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Description
Generic Minor Consent Form document sample
Document Sample
* indicates answer is required in eResearch
Red text and yellow shaded areas represent 1.6 Release Changes Review Routing:
Required for all
1. General Study Information studies
1.1 * AE/ORIO Title: Leave the HUM Number in the title, then revise
the title to indicate the type of report you are completing (AE or ORIO),
and your referent for the report. Examples: HUM00003155_Adverse
Event – UM 3/15/06, HUM00003155_ORIO_Subject Incarceration 3-30-
06
This report is being submitted for the following study:
1.2 * Type of Report -- choose one
Select one:
Adverse Events Report
Other Reportable Information or Occurrence (ORIO)
1-1. Report of Adverse Event (AE)
1-1.1 * Adverse Event types:
UM Serious Adverse Events Report
UM Non-Serious Adverse Events Report
External Adverse Events Report
UM Coordinating Center Aggregate Adverse Events Report
1-1.2 * Does this report include follow-up to previously reported
events?
1-2. Other Reportable Information or Occurrence (ORIO)
1-2.1 * Other Reportable Information or Occurrences (ORIO) types:
Protocol deviation/violation
Report(s) to or from oversight entity
Subject incarceration
Accident/incident
Notification of audit/inspection/inquiry
Pertinent publication/public announcement
Complaint
Subject withdrawal
1-2.2 * Does this report include follow-up to previously reported
events?
1-3. Previous Adverse Events
1-3.1 * Indicate all previously approved reports being updated:
1-4. Previous ORIOs (Other Reportable Information or Occurrence)
1-4.1 * Indicate which previous report is being updated:
2. UM Serious AE Reporting Form
2.1 AE/ORIO Title:
This report is being submitted for the following study:
2.2 * UM Serious Adverse Events
2.3 * UM investigator‘s overview assessment of new and/or updated
information in this submission.
An ‗overview assessment‘ should address the following if they apply:
Explain how AEs included in this report impact the study
List any AEs that the UM investigator believes the IRB should give
special attention and explain why
List any AEs recorded as ‗unrelated‘ in 2.2 that the UM investigator
believes were caused by participating in the study even if not caused
by the drug, device, or other intervention under direct study
List any AEs on which the UM PI and an oversight body disagree (e.g
the sponsor‘s opinion of seriousness, relatedness, or expectedness
differs from the UM PI's). Provide the event numbers and explain the
disagreement.
Explain voluntary holds or urgent changes that will be initiated on any
part of the study because of the AEs included in this report. Provide a
description of the changes and rationale.
NOTE: Solely referring to uploaded document(s) or other sections
without providing an overview is not acceptable.
2.4 * Are subjects still being recruited at any of these sites?
2.5 * Are subjects still participating or being monitored at any of the
sites listed in 2.4?
2.6 * Indicate which of the following parties, identified as providing
additional monitoring in the currently approved data and safety
monitoring plan, will be notified of this event. If this has changed,
describe the change in Additional Information below and complete and
submit an eResearch Amendment Application.
2.7 * Will any changes/amendments be made to the research because
of information included in this report (including informing currently
enrolled subjects and/or those who have completed the study)?
Note—amendments cannot be made as part of this report. In order to
amend items checked below, go to the study‘s home work-space and
complete an amendment (click on the Amendment activity in the lower
left of study‘s home work space)
2.7.1 If yes, indicate all aspects of the research that will be changed:
Select all that apply:
Risk Assessment
Informed Consent Document
Informed Consent Document with re-consenting of all previously
enrolled subjects
Informed Consent Document with re-consenting of previously enrolled
subjects still receiving research intervention or investigational agents
Intervention or investigational agents
Protocol
Investigator‘s Brochure
Other
If Other, please specify:
2.7.2 If applicable, indicate the revised risk assessment that will be
made on an amendment application:
2.8 Additional information: Provide additional pertinent information. If
you require documentation of IRB submission for any information not
requested/required in other fields, enter it here.
2.2 UM Serious Adverse Event Detail
This form is only for events that meet the following definition:
Definition of serious adverse event:
An adverse experience that resulted in any of the following outcomes:
Death
A life-threatening experience
Severe social, psychiatric/psychological, familial, or financial harm
related to the research
Inpatient hospitalization or prolongation of existing hospitalization
A persistent or significant disability/incapacity
A congenital anomaly/birth defect
Events that jeopardize the patient or subject and may require medical,
psychiatric, dental, or surgical intervention to prevent one of the
outcomes listed in this definition.
2.2.1 * Provide unique identifier for this event
2.2.2 * Initial date of event:
2.2.3 * Date event came to the attention of the study team:
2.2.4 * Location of responsible UM performance site (check all that
apply):
2.2.5 * Coded subject identifier:
2.2.6 * Provide up to six keyword descriptors for this AE:
2.2.7 * Relatedness: What is the current assessment?
If UM PI and oversight entity disagree about this assessment or if UM
PI believes the AE to be related to the research and not just related to
an agent, drug or device involved in the research explain in 2.3.
See the Help for links to definitions.
2.2.8 * Is this event expected?
If UM PI and oversight entity disagree about this assessment, explain
in 2.3.
2.2.8.1 If yes, indicate how the event meets the UM definition of
expected by checking all that apply below:
Informed consent document(s) for this study
IRB application for this study
Grant application or study agreement
Protocol or procedures for this study
Investigators‘ brochure or equivalent (for FDA regulated drugs or
devices)
DSMB/DSC Reports
Published literature
Other
If Other, please specify:
2.2.8.2 If item(s) checked have not been previously provided to the
IRB, upload them here (Uploading documents here does not
preclude the requirement for an amendment or ORIO if such is
required by IRB guidance or policy):
2.2.9 * Severity:
Select one:
Grade Definition
1 Mild AE - No treatment needed (NCI CTC Grade 1)
2 Moderate AE – Resolved with treatment (NCI CTC Grade 2)
3 Severe AE – Inability to carry on normal activities, required
professional medical or psychiatric attention (NCI CTC Grade 3)
4 Life-threatening or disabling AE (NCI CTC Grade 4)
5 Fatal AE (NCI CTC Grade 5)
2.2.10 * Event Information. Briefly describe the event and discuss:
what happened (including where the adverse event occurred if known)
description of the subject (as it relates to the research)
circumstances of the event
how the problem was detected
how problem was treated or addressed
what phase of study the subject was at (e.g. consented, receiving
intervention, receiving a drug or device, dose, length of time received,
number of doses received)
2.2.11 Primary Supporting Documentation:
2.2.11.1 Upload primary supporting documentation here. Name the
document with the report identifier and date (Example: MedWatch
30937 5-5-2006). No uncoded subject or patient identifiers should
appear on the uploaded document (e.g. subject‘s name).
2.2.11.2 Date of primary supporting document:
2.2.12 Other Supporting Documents:
2.2.12.1 Upload other supporting documentation here. Name the
document with its title and date (Example: Sponsor-Cover-Letter-2-
16-06).
3. UM Non-serious AE Reporting Form
3.1 AE/ORIO Title:
This report is being submitted for the following study:
3.2 * UM Non-serious Adverse Events
3.3 * UM investigator‘s overview assessment of new and/or updated
information in this submission.
An ‗overview assessment‘ should address the following if they apply:
Explain how AEs included in this report impact the study
List any AEs that the UM investigator believes the IRB should give
special attention and explain why
List any AEs recorded as ‗unrelated‘ in 3.2 that the UM investigator
believes were caused by participating in the study even if not caused
by the drug, device, or other intervention under direct study
List any AEs on which the UM PI and an oversight body disagree (e.g
the sponsor‘s opinion of seriousness, relatedness, or expectedness
differs from the UM PI's). Provide the event numbers and explain the
disagreement.
Explain voluntary holds or urgent changes that will be initiated on any
part of the study because of the AEs included in this report. Provide a
description of the changes and rationale.
NOTE: Solely referring to uploaded document(s) or other sections
without providing an overview is not acceptable.
3.4 * Are subjects still being recruited at any of these sites?
3.5 * Are subjects still participating or being monitored at any of the
sites listed in 3.4?
3.5.1 Indicate level of subject participation (check all that apply):
Select all that apply:
Subjects are receiving investigational agents (FDA regulated studies)
Subjects are receiving research intervention
Subjects are being contacted by or interacting with researchers
(active participation and/or follow-up)
Subjects records are being followed
3.6 * Indicate which of the following parties, identified as providing
additional monitoring in the currently approved data and safety
monitoring plan, will be notified of this event. If this has changed,
describe the change in Additional Information below and complete and
submit an eResearch Amendment Application.
3.7 * Will any changes/amendments be made to the research because
of information included in this report (including informing currently
enrolled subjects and/or those who have completed the study)?
Note—amendments cannot be made as part of this report. In order to
amend items checked below, go to the study‘s home work-space and
complete an amendment (click on the Amendment activity in the lower
left of study‘s home work space)
3.7.1 If yes, indicate all aspects of the research that will be changed:
Select all that apply:
Risk Assessment
Informed Consent Document
Informed Consent Document with re-consenting of all previously
enrolled subjects
Informed Consent Document with re-consenting of previously enrolled
subjects still receiving research intervention or investigational agents
Intervention or investigational agents
Protocol
Investigator‘s Brochure
Other
If Other, please specify:
3.7.2 If applicable, indicate the revised risk assessment that will be
made on an amendment application:
3.8 Additional information: Provide additional pertinent information. If
you require documentation of IRB submission for any information not
requested/required in other fields, enter it here.
3.2 UM Non-serious Adverse Event Detail
3.2.1 * Is this an aggregate report. NOTE: Events not described in the
currently approved informed consent document cannot be included in
aggregate reports (i.e. cannot be on spreadsheets of multiple events).
They must be reported on their own detail page.
3.2.1.1 If yes, indicate the total number of reported adverse events in
each of the following categories:
Do not complete for a single incident report.
3.2.2 * Provide a unique identifier for this event or a report identifier for
a spreadsheet.
For aggregate reports events upload a spreadsheet in 3.2.12.2 that
includes all required data needed for IRB review
3.2.3 * Initial date of event:
For aggregate reports provide the date of the earliest event on the
spreadsheet.
3.2.4 * Date event came to the attention of the study team:
For aggregate reports provide the earliest date an included event came
to the study team‘s attention.
3.2.5 * Location of responsible UM performance site (check all that
apply):
3.2.6 Coded subject identifier:
For aggregate reports, skip this question.
3.2.7 * Provide up to six keyword descriptors for this AE:
For aggregate reports provide a description of the report.
3.2.8 * Relatedness: What is the current assessment?
If UM PI and oversight entity disagree about this assessment or if UM
PI believes the AE to be related to the research and not just related to
an agent, drug or device involved in the research explain in 3.4.
See the Help for links to definitions.
For aggregate reports, answer 'definitely related' if one or more events
on the spreadsheet is 'definitely related' (if none are 'definitely related,
but one or more are 'probably related', answer 'probably related. Same
for 'possibly related').
3.2.9 * Is this event and/or the incidence, severity, and magnitude
expected?
If UM PI and oversight entity disagree about this assessment, explain
in 2.4.
For aggregate reports answer ‗no‘ if one or more events on the
spreadsheet is unexpected. NOTE: Events not described in the
currently approved informed consent document cannot be included in
aggregate reports (i.e. cannot be on spreadsheets of multiple events).
They must be reported on their own detail page.
3.2.9.1 If yes, indicate how the event meets the UM definition of
expected by checking all that apply below:
Location
Informed consent document(s) for this study
IRB application for this study
Grant application or study agreement
Protocol or procedures for this study
Investigators‘ brochure or equivalent (for FDA regulated drugs or
devices)
DSMB/DSC Reports
Published literature
Other
If Other, please specify:
3.2.9.2 If item(s) checked have not been previously provided to the
IRB, upload them here (Uploading documents here does not
preclude the requirement for an amendment or ORIO if such is
required by IRB guidance or policy):
3.2.10 * Severity:
For aggregate reports choose the highest grade noted on the
spreadsheet.
3.2.11 * Event Information: Briefly describe the event. Discuss:
what happened (including where the adverse event occurred if known)
description of the subject (as it relates to the research)
circumstances of the event
how the problem was detected
how problem was treated or addressed
what phase of study the subject was at (e.g. consented, receiving
intervention, receiving a drug or device, dose, length of time received,
number of doses received)
For aggregate reports provide a summary overview of the report
3.2.12 Primary Supporting Documentation:
3.2.12.1 Date of primary supporting document:
3.2.12.2 Upload primary supporting documentation here. Name the
document with the report identifier and date (Example: MedWatch
30937 5-5-2006). No uncoded subject or patient identifiers should
appear on the uploaded document (e.g. subject‘s name).
For aggregate reports upload the spreadsheet here.
3.2.13 Other Supporting Documents:
3.2.13.1 Upload other supporting documentation here. Name the
document with its title and date (Example: Sponsor-Cover-Letter-2-
16-06).
4. External AE Reporting Form
General Instructions: read and follow all instructions.
To add a new event or upload a spreadsheet of multiple events, click
the Add button in section 4.2. A ‗detail page‘ will open. Answer the
questions on the detail page and click OK or OK and Add Another. The
table will auto-fill with the information provided in the detail page.
NOTE: Events not described in the currently approved informed
consent document cannot be included in aggregate reports (i.e. cannot
be on spreadsheets of multiple events). They must be reported on their
own detail page.
To update a previously reported event click the particular ―Event
Identifier‖ in the table. A ‗detail page‘ will open. Update the questions
on the detail page and click OK. The table will auto-update with the
information provided in the detail page
To submit a follow-up report about an event not previously reported to
the UM IRB add a row to the appropriate table (as done with an initial
report). Record the event according to the information provided in the
follow-up report. Indicate in the ‗Follow-up Comments‘ column that the
event was ―Previously un-reported at UM for this study.‖
Complete the remaining sections.
Click Finish when done.
4.1 AE/ORIO Title:
This report is being submitted for the following study:
4.2 * Subjects are enrolled at non-UM sites.
4.2.11 ―Comments:
These comments also display on the table in section 4.2 of this
submission (e.g. additional information about this event). These
comments do not appear on the approval letter.‖
Updated for 1.6
4.3 * UM investigator‘s overview assessment of new or updated
information in this submission.
An ‗overview assessment‘ should address the following if they apply:
Explain how AEs included in this report impact the study
List any AEs that the UM investigator believes the IRB should give
special attention and explain why
List any AEs recorded as ‗unrelated‘ in 4.2 that the UM investigator
believes were caused by participating in the study even if not caused
by the drug, device, or other intervention under direct study
List any AEs on which the UM PI and an oversight body disagree (e.g
the sponsor‘s opinion of seriousness, relatedness, or expectedness
differs from the UM PI's). Provide the event numbers and explain the
disagreement.
Explain voluntary holds or urgent changes that will be initiated on any
part of the study because of the AEs included in this report. Provide a
description of the changes and rationale.
NOTE: Solely referring to uploaded document(s) or other sections
without providing an overview is not acceptable.
4.4 * Are subjects still being recruited at sites under UM oversight?
4.5 * Are subjects still receiving the investigational intervention at sites
under UM oversight?
4.6 * Will any changes/amendments be made to the research because
of information included in this report (including informing currently
enrolled subjects and/or those who have completed the study)?
Note—amendments cannot be made as part of this report. In order to
amend items checked below, go to the study‘s home work-space and
complete an amendment (click on the Amendment activity in the lower
left of study‘s home work space)
4.6.1 If yes, indicate all aspects of the research that will be changed:
Select all that apply:
Risk Assessment
Informed Consent Document
Informed Consent Document with re-consenting of all previously
enrolled subjects
Informed Consent Document with re-consenting of previously enrolled
subjects still receiving research intervention or investigational agents
Intervention or investigational agents
Protocol
Investigator‘s Brochure
Other
If Other, please specify:
4.6.2 If applicable, indicate the revised risk assessment that will be
made on an amendment application:
4.7 Additional information: Provide additional pertinent information. If
you require documentation of IRB submission for any information not
requested/required in other fields, enter it here.
4.2 External Adverse Event Detail
4.2.1 * The subject(s) involved in the adverse event(s):
Is enrolled at a non-UM site in the multi-site study that this UM study is
a part of (the same protocol as this study is being followed but a non-
UM IRB has direct oversight of the investigator handling the AE).
Is enrolled in a different research study involving an agent, procedure,
or other intervention that is included in this research study but involves
a different protocol, disease, dose, study population etc.
Is not enrolled any research at any site (received an agent, procedure,
or other intervention involved as part of clinical care).
4.2.2 * Is this an aggregate report?
4.2.2.1 If yes, indicate the total number of reported adverse events in
each of the following categories:
Do not complete for a single incident report.
4.2.3 * Provide unique identifier for this event or a report identifier for
events reported in aggregate (multiple events listed on a spreadsheet
that includes all required data needed for IRB review).
For aggregate reports upload a spreadsheet in 4.2.9.2 that includes all
required data for IRB review.
4.2.4 * Initial date of event:
For aggregate reports provide the date of the earliest event on the
spreadsheet.
4.2.5 * Provide up to six keyword descriptors for this AE:
For aggregate reports provide a description of the report.
4.2.6 * Is this event serious? UM PI and report source (e.g. a sponsor)
disagree about this assessment, explain in 3.4.
For aggregate reports choose ‗yes‘ if one or more AEs on the
spreadsheet is serious.
4.2.7 * Relatedness: What is the current assessment?
UM PI and report source (e.g. a sponsor) disagree about this
assessment, explain in 3.4. If UM PI and oversight entity disagree
about this assessment or if UM PI believes the AE to be related to the
research and not just related to an agent, drug or device involved in the
research explain in 3.4.
See the Help for links to definitions.
For aggregate reports, answer 'definitely related' if one or more events
on the spreadsheet is 'definitely related' (if none are 'definitely related,
but one or more are 'probably related', answer 'probably related. Same
for 'possibly related').
4.2.8 * Is this event expected?
For aggregate reports answer ‗no‘ if one or more events on the
spreadsheet is unexpected. NOTE: Events not described in the
currently approved informed consent document cannot be included in
aggregate reports (i.e. cannot be on spreadsheets of multiple events).
They must be reported on their own detail page.
4.2.8.1 If yes, indicate how the event meets the UM definition of
expected by checking all that apply below:
Informed consent document(s) for this study
IRB application for this study
Grant application or study agreement
Protocol or procedures for this study
Investigators‘ brochure or equivalent (for FDA regulated drugs or
devices)
DSMB/DSC Reports
Published literature
Other
If Other, please specify:
4.2.9 Primary Supporting Documentation:
4.2.9.1 Date of primary supporting document:
4.2.9.2 Upload primary supporting documentation here. Name the
document with the report identifier and date (Example: MedWatch
30937 5-5-2006). No uncoded subject or patient identifiers should
appear on the uploaded document (e.g. subject‘s name).
For aggregate reports upload the spreadsheet here.
4.2.10 Other Supporting Documents:
4.2.10.1 Upload other supporting documentation here. Name the
document with its title and date (Example: Sponsor-Cover-Letter-2-
16-06).
4.2.11 Comments. Begin comments with any information needed to
display on the table in the main form (e.g. a document identifier you
need readily visible for sponsor requirements). Include detail of
events as PI or sponsor deems necessary and appropriate.
5. Coordinating Center AE Reporting Form
5.1 AE/ORIO Title:
This report is being submitted for the following study:
5.2 * UM Coordinating Center Adverse Events
Initial and/or follow-up reports of adverse events involving subjects at
sites reporting to UM as a coordinating center.
NOTE TO IRB REVIEWERS: Detail pages may include information in
addition to that displayed in the table. Blank fields in the table indicate
that non-required/optional information was not provided on the detail
page.
5.3 * UM Investigator‘s Overview Assessment of new or updated
information in this submission.
An ‗overview assessment‘ should address the following if they apply:
Explain how AEs included in this report impact the study
List any AEs that the UM investigator believes the IRB should give
special attention and explain why
List any AEs recorded as ‗unrelated‘ in 5.2 that the UM investigator
believes were caused by participating in the study even if not caused
by the drug, device, or other intervention under direct study
List any AEs on which the UM PI and an oversight body disagree (e.g
the sponsor‘s opinion of seriousness, relatedness, or expectedness).
Provide the event numbers and explain the disagreement.
Explain voluntary holds or urgent changes that will be initiated on any
part of the study because of the AEs included in this report. Pprovide a
description of the changes and rationale.
NOTE: Solely referring to uploaded document(s) or other sections
without providing an overview is not acceptable.
5.4 * Are Are subjects still being recruited at sites under UM oversight?
5.5 * Are subjects still receiving the investigational intervention at sites
under UM oversight?
5.5.1 Indicate level of subject participation:
5.6 * Indicate which of the following parties, identified as providing
additional monitoring in the currently approved data and safety
monitoring plan, will be notified of this event. If this has changed,
complete and submit an eResearch Amendment Application and
describe the change in Additional Information below.
5.7 * Will any changes/amendments be made to the research because
of information included in this report (including informing currently
enrolled subjects and/or those who have completed the study)?
Note—amendments cannot be made as part of this report. In order to
amend items checked below, go to the study‘s home work-space and
complete an amendment (click on the Amendment activity in the lower
left of study‘s home work space)
5.7.1 If yes, indicate all aspects of the research that will be changed:
Select all that apply:
Risk Assessment
Informed Consent Document
Informed Consent Document with re-consenting of all previously
enrolled subjects
Informed Consent Document with re-consenting of previously enrolled
subjects still receiving research intervention or investigational agents
Intervention or investigational agents
Protocol
Investigator‘s Brochure
Other
If Other, please specify:
5.7.2 If applicable, indicate the revised risk assessment that will be
made on an amendment application:
5.8 Additional information: Provide additional pertinent information. If
you require documentation of IRB submission for any information not
requested/required in other fields, enter it here.
5.2 Coordinating Center Adverse Event Detail
5.2.1 * Is this an aggregate report. NOTE: Events not described in the
currently approved informed consent document cannot be included in
aggregate reports (i.e. cannot be on spreadsheets of multiple events).
They must be reported on their own detail page.
5.2.1.1 If yes, indicate the total number of reported adverse events in
each of the following categories:
Do not complete for a single incident report. The number will be
calculated based on the answers below.
5.2.2 * Provide a unique identifier for this event or a report identifier for
a spreadsheet.
For aggregate reports events upload a spreadsheet in 5.2.10.2 that
includes all required data needed for IRB review
5.2.3 * Initial date of event:
For aggregate reports provide the date of the earliest event on the
spreadsheet.
5.2.4 Coded subject identifier:
For aggregate reports, skip this question.
5.2.5 * Provide up to six keyword descriptors for this AE:
For aggregate reports provide a description of the report.
5.2.6 * Relatedness: What is the current assessment?
If UM PI and oversight entity disagree about this assessment or if UM
PI believes the AE to be related to the research and not just related to
an agent, drug or device involved in the research explain in 5.4.
See the Help for links to definitions.
For aggregate reports choose the assessment that reflects the
strongest relationship noted on the spreadsheet.
5.2.7 * Is this event and/or the incidence, severity, and magnitude
expected?
If UM PI and oversight entity disagree about this assessment, explain
in 2.4.
For aggregate reports answer ‗no‘ if one or more events on the
spreadsheet is unexpected. NOTE: Events not described in the
currently approved informed consent document cannot be included in
aggregate reports (i.e. cannot be on spreadsheets of multiple events).
They must be reported on their own detail page.
5.2.7.1 If yes, indicate how the event meets the UM definition of
expected by checking all that apply below:
Location
Informed consent document(s) for this study
IRB application for this study
Grant application or study agreement
Protocol or procedures for this study
Investigators‘ brochure or equivalent (for FDA regulated drugs or
devices)
DSMB/DSC Reports
Published literature
Other
If Other, please specify:
5.2.7.2 If item(s) checked have not been previously provided to the
IRB, upload them here:
5.2.8 * Severity:
For aggregate reports choose the highest grade noted on the
spreadsheet.
5.2.9 * Event Information. Briefly describe the event and discuss:
what happened (including where the adverse event occurred if known)
description of the subject (as it relates to the research)
circumstances of the event
how the problem was detected
how problem was treated or addressed
what phase of study the subject was at (consented, receiving
intervention, receiving a drug or device, dose, length of time received,
number of doses received)
5.2.10 Primary Supporting Documentation:
5.2.10.1 Date of primary supporting document:
5.2.10.2 Upload primary supporting documentation here. Name the
document with the report identifier and date (Example: MedWatch
30937 5-5-2006). No uncoded subject or patient identifiers should
appear on the uploaded document (e.g. subject‘s name).
For aggregate reports upload the spreadsheet here.
5.2.11 Other Supporting Documents:
5.2.11.1 Upload other supporting documentation here. Name the
document with its title and date (Example: Sponsor-Cover-Letter-2-
16-06).
6. Protocol Deviation/Violation Report
6.1 * Protocol Deviation/Violation involving:
Select all that apply:
Single/isolated incident
Multiple incidents indicating a systemic problem
Inadvertent/accidental protocol departure
Deliberate protocol departure for subject‘s safety
Deliberate protocol departure for other reason (specify in description)
Breach of confidentiality
Schedule deviation (appointment, visit, data collection point)
Dosage/intervention errors or deviations
Informed consent process deviations or problems
Eligibility criteria deviations
6.2 General Information
6.2.1 * Date Deviation/Violation occurred:
6.2.2 * Date the Deviation/Violation came to the attention of the study
team:
6.2.3 * From what source did the study team receive the information?
6.2.4 * Date subject was enrolled (consented) in study:
6.2.5 Subject identifier: (use study number, codes, etc. - no name,
initials, SSN, or CPI Number)
6.3 * Description of Event or Information
6.4 Investigators‘ Assessment
6.4.1 * Is/was there a potential for physical, social, or psychological
harm to the subject, others, society at large, or the environment?
6.4.2 * Has the integrity or validity of the data been compromised?
6.5 * Investigators' Response: Briefly discuss how the event or
information will be addressed, rectified, or resolved. Provide
justification for inclusion of subject data in study analysis if applicable.
What measures will be taken to prevent this event from happening
again.
6.6 Additional Information: Provide additional pertinent information.
6.7 Supporting Documentation: Upload all supporting documentation
here.
7. Subject Incarceration
7.1 * This submission is to report:
Select one:
Enrollment of a subject who is currently a prisoner (Note: consider
enrollment to be the point at which
the prisoner provided informed consent to participate in the study)
Incarceration of a previously-enrolled subject
7.2 * General Information
7.2.1 * Date subject was enrolled (consented) in study:
7.2.2 * Date study team became aware of prisoner status:
7.2.3 * Subject identifer: (use codes, study number, etc. no name,
initials, SSN, or CPI#)
7.2.4 * How did the study team become aware of the subject‘s prisoner
status?
7.2.5 * Indicate which prison/correctional facility has jurisdiction over
the prisoner.
7.2.6 * Will the location for the conduct of the research be different
than described in the currently approved study?
7.2.7 * Describe the timing of necessary interactions/interventions
relative to the subject's incarceration.
7.3 * Description of event and investigator‘s assessment. Describe the
circumstances around the enrollment of a prisoner or the incarceration
of a previously enrolled subject. Justify the subject‘s participation or
continued participation during their incarceration. Describe the manner
in which the incarceration may impact the conduct of the study.
7.4 Additional Information: Provide additional pertinent information.
7.5 Supporting Documentation: Upload all supporting documentation
here.
8. Data/Specimen/Facility Accident or Incident Report:
8.1 * This report is for an accident or incident involving:
Select all that apply:
Study data
Study specimen(s)
Study facility
Other (specify in 5.3 Description of Event)
8.2 General Information
8.2.1 * Date study team became aware of event:
8.2.2 * From what source did the study team receive the information?
8.3 * Description of Event: Briefly describe what happened, how many
subjects were affected and in what way, how the problem was
detected, how it did or could affect the study overall, etc. Include any
known regulatory compliance issues.
8.4 Investigators‘ Assessment
8.4.1 * Is/was there a potential for physical, social, or psychological
harm to the subject, others, society at large, or the environment?
8.4.2 * Has the integrity or validity of the data been compromised?
8.5 * Investigators‘ Response: Briefly discuss how the event was or will
be addressed, rectified, or resolved. Provide justification for inclusion
of subject data in study analysis, if applicable. What measures will be
taken to prevent a recurrence of this event.
8.6 Additional Information: Provide any additional pertinent information.
8.7 Supporting Documentation: Upload all supporting documentation
here.
9. Notification of Audit/Inspection/Inquiry
9.1 * Official Audit/Inspection/Inquiry Notification received from: Select
one:
Internal UM Office (University Internal Audits, ORCR, OVPR)
DSMB/DSC
FDA
Other Government Oversight Agency (OHRP, OBA, NRC, ORI, ORC,
OIG etc)
Granting Agency (NIH, NSF, NCI, etc)
Non-routine Sponsor Inspection
Other (specify in description)
9.2 General Information
9.2.1 * Date study team received notification of audit/inspection/inquiry:
9.2.2 Dates of the on-site audit/inspection/inquiry:
9.2.3 Date range of materials to be audited or inspected:
9.2.4 * This audit/inspection/inquiry is classified as: Select one:
Announced
Unannounced – describe in 6.3 Description of Audit/Inspection/Inquiry
9.2.5 * This audit/inspection/inquiry is classified as: Select one:
Routine
For cause – describe in 6.3 Description of Audit/Inspection/Inquiry
9.3 * Description of Audit/Inspection/Inquiry: Briefly describe the nature
of the audit/inspection/inquiry. Specify the agency conducting the
audit/inspection/inquiry, the purpose of the inspection, personnel
involved, the activities or records involved, etc.
9.4 Additional Information: Provide any additional pertinent information.
9.5 Supporting Documentation: Upload all supporting documentation
here.
10. Report(s) Submitted To or Received From an Oversight Entity
10.1 * Indicate whether report(s) are to or from the following oversight
entities. Select all that apply:
Sponsor report, advisory, or update
Internal UM office (University Internal Audits, IRB, ORCR, OVPR or
reports of study activity conducted during lapse of IRB approval)
DSMB/DSC
FDA Form 483, EIR, Warning Letter, NIDPO, etc.
Other government oversight agency (OHRP, OBA, NRC, ORI, ORC,
OIG etc)
Granting agency (NIH, NSF, NCI, etc.) communication impacting the
conduct of this human subjects study
Other (specify in 10.3 Description of Report)
10.2 General Information
10.2.1 * Provide up to six keyword descriptor for this report:
10.2.2 * Date study team submitted or received report:
10.2.3 * Specify the oversight entity involved in the communication:
10.3 * Description of Report: Briefly describe the purpose of the report.
10.4 Investigators‘ Assessment
10.4.1 * Is/was there a potential for physical, social, or psychological
harm to the subject, others, society at large, or the environment?
10.4.2 * Has the integrity or validity of the data been compromised?
10.5 * Investigators‘ Response: Briefly discuss how the report
information will be addressed, rectified or resolved. If reporting a study
lapse, briefly describe any study activity conducted during lapse of IRB
approval.
10.6 Additional Information: Provide any additional pertinent
information.
10.7 Supporting Documentation: Upload all supporting documentation
here.
11. Pertinent Publications/Public Announcements
11.1 * Characterize the source of the publication or public
announcement: Select all that apply:
Scientific publication
Media coverage
Public heath announcement
Other – describe in 8.3 Description of Information
11.2 General Information
11.2.1 * Provide up to six keyword descriptor for this report:
11.2.2 * Date study team became aware of information:
11.2.3 * Name the publication or the official source of the information:
11.3 * Description of Information: Briefly summarize the information.
11.4 * Investigators‘ Assessment: The information in the publications/
public announcement could: Select all that apply:
Impact subject willingness to participate in study (e.g. negative, overly
inducive, or confusing media attention)
Impact risk or benefit to subject
Necessitates change to study protocol
Necessitates change to Informed Consent Document
Necessitates information letter to subject
Other - describe in 8.6 Investigator's Response
The information is not expected to affect the conduct of the study
11.5 * Investigators‘ Response: Briefly discuss how the impact of the
information was or will be addressed.
11.6 Additional Information: Provide any additional pertinent
information.
11.7 Supporting Documentation: Upload all supporting documentation
here, including electronic copies of the publications or announcements.
12. Complaint
12.1 The complaint is:
Select one:
Resolved
Unresolved
12.2 General Information
12.2.1 * Date study team became aware of complaint:
12.2.2 * Complaint was made by:
Select one:
Subject
Subject Advocate
Heath care provider
Study Team Member
Other - describe in 9.3 Description of Complaint
12.2.3 * Did the complaint center around specific subjects?
12.2.3.1 If yes, Identify the subject's date of enrollment and the subject
identifier: (use study number, codes, etc. no name, initials, SSN, or
CPI#)
12.2.4 * Provide up to six keyword descriptors for this complaint:
12.3 * Description of Complaint:
12.4 Investigators‘ Assessment
12.4.1 * Is/was there a potential for physical, social, or psychological
harm to the subject, others, society at large, or the environment?
12.4.2 * Has the integrity or validity of the data been compromised?
12.5 * Investigators‘ Response: Briefly discuss how the complaint was
or will be addressed, rectified, or resolved. What measures will be
taken to prevent future similar complaints.
12.6 Additional Information: Provide any additional pertinent
information.
12.7 Supporting Documentation: Upload all supporting documentation
here
13. Subject Withdrawal
13.1 * Reason for subject's withdrawal:
Select all that apply:
Study time requirements
Study-related pain, discomfort, or distress
Subject relocation
Subject lost to follow-up
Investigator's prerogative
Other – specify in 10.3 Description of Withdrawal
13.2 General Information
13.2.1 * Date of subject withdrawal or date study team determined that
subject had withdrawn:
13.2.2 * Date subject was enrolled (consented) in study:
13.2.3 Subject identifer: (use codes, study number, etc. no name,
initials, SSN, or CPI#)
13.2.4 * Will the subject‘s data be included in study analyses? If yes,
provide scientific justification in 13.6 Additional Information.
13.2.5 * Did the subject withdraw their HIPAA authorization for use of
PHI?
13.3 * Description of Withdrawal: Briefly describe the circumstances
surrounding the subject‘s withdrawal.
13.4 Investigators‘ Assessment
13.4.1 * Is/was there a potential for physical, social, or psychological
harm to the subject, others, society at large, or the environment?
13.4.2 * Has the integrity or validity of the data been compromised?
13.5 * Investigators‘ Response: Briefly address whether the subject‘s
withdrawal will have an affect on the study overall. Discuss any
emerging patterns for withdrawal or reasons for withdrawal.
13.6 Additional Information: Provide any additional pertinent
information.
13.7 Supporting Documentation: Upload all supporting documentation
here.
14. Supporting Documents List
14.1 ―If the study sponsor requires that the IRBMED approval letter
contain a list of supporting documents, list the names of the
documents in the box below as they should appear on the IRBMED
approval letter‖
New for 1.6
Committee
Smartform logic Specific Info
ence (ORIO)
mation or Occurrence)
If yes, answer 2.5.1.
If no, skip to 2.6
If no, skip to 2.8
If yes, answer 3.5.1.
If no, skip to 3.6
If no, skip to 3.8
If no, skip to 4.7
fixed typo
Version 1.6: no longer a required
question.
ent Report:
m an Oversight Entity
Question # (* indicates answer is required in eResearch)
Review
Routing:
0.1 * Amendment Title (limited to 256 characters):
This amendment is being submitted for the following application:
Study Title: (auto-populated)
PI: (auto-populated)
Expiration Date: (auto-populated)
eResearch ID: (auto-populated)
GCRC ID: (auto-populated)
Cancer PRC ID: (auto-populated)
1.2 * Subject Enrollment Status: (Note: This information will also need to be provided at
scheduled continuing review) Projected subject enrollment for the study:
Total number of subjects enrolled to date:
Remaining subjects to be enrolled:
1.3 * Provide up to six keyword descriptors for this Amendment.
1.4 * Proposed changes:
Select all that apply:
Change to the risk level or anticipated benefits to research subjects. Section 6 - Benefits and
Risks
Change to the informed consent document or process. Section 10 - Informed Consent
Change that may affect the safety or well being of the research subject. Section 6 - Benefits
and Risks
Change in research goals or specific objectives. Section 5 - Research Design
Change in eligibility criteria. Section 8 - Subject Description
Change in accrual. Section 8-1 -Subject Participation
Change in therapy, intervention, or interaction (e.g changes in dosing, schedule, addition or
deletion of therapeutic agents or protocol specific treatment, etc.) Section 5 - Research
Design
Changes to study specific evaluations (e.g. change in statistical analysis, addition/deletion of
blood test, clinical visits, etc.) Section 5 - Research Design
Administrative changes (e.g. addition/deletion of investigator(s), change in study team, etc.)
Section 1 - General Study Information
Other - Describe below.
1.5 * For each proposed change, provide a description and justification. Proposed changes
to uploaded supporting documention (e.g., research protocol, informed consent document,
investigator's brochure, survey instrument, recruitment script, etc.) may not be readily
apparent to reviewers and therefore should be described here in detail.
1.6 * Why is this amendment being requested?
Select all that apply:
Required for conversion to eResearch
Initiated by principal investigator
Initiated by study sponsor, cooperative group, coordinating center, etc.
Response to an adverse event (AE) or other reportable information or occurrence (ORIO)
Response to a regulatory requirement
Other
1.6.1 If this amendment is in response to one or more AEs/ORIOs, select the related
AEs/ORIOs below: If no AEs/ORIOs appear, it's because none have been submitted.
Committee
Specific
Smartform logic Info Comments
* indicates answer is required in eResearch
Red text and yellow shaded areas represent 1.6
Release Changes Review Routing: Smartform logic
Scheduled Continuing Review (SCR) or Termination
The SCR or Termination is only for renewing or
terminating an already approved study.
Changes to the study must be made via an
Amendment.
Any changes to the study or its supporting documents
must be submitted to the IRB separately using an
eResearch Amendment. The amendment application
provides a copy of the currently approved application
that can be edited to indicate changes. The SCR or
Termination is an update report only and does not
allow for changes to be made to the study.
Submit Adverse Events or ORIOs before continuing
with this SCR.
Adverse events (AEs) and other reportable information
and occurrences (ORIOs) occuring in the approval
period must be recorded in eResearch before creating
the SCR or Termination. If there are unrecorded AE or
ORIOs, click the Back button and select New Adverse
Event/ORIO. AE and ORIOs must be submitted prior
to the initiation of the SCR or Termination in order for
them to automatically display in the SCR or
Termination report.
0.1 * SCR or Termination Title:
1.0 Study Activity Status
1.1 * Characterize the ongoing study activity.
Select one:
Renewal - study activity continues to include
ongoing or future research interaction/intervention with
subjects or collection of identifiable private information.
Renewal – activity limited to subject follow-up and
analysis of identifiable data. All research intervention
has been completed. Interaction is limited to follow-up
activities only. Data continues to contain subject
identifiers or links.
Renewal – activity limited to analysis of
identifiable data. All research interaction and
intervention has been completed. Data continues to
contain subject identifiers or links.
Renewal – activity limited to analysis of de-
identified data. All research interaction and
intervention with subjects or collection of identifiable
private information has been completed. The subject
identifiers held by the study team (including links and
lists) have been destroyed.
Renewal - umbrella project. The study lacks
immediate plans for involvement of human subjects,
their data, or their specimens.
Termination Report. The study is completed; there is
no further subject recruitment, follow-up, or data
analysis.
1.1.1 If study activity continues to include research
interaction/intervention with subjects, has subject
enrollment concluded?
1.1.2 If terminating, reason for termination (e.g. study
is complete including data analysis, funding was not
obtained, investigator relocated).
1.2 Describe any significant new findings or
information developed during the course of this
research or other associated research that may relate
to a subject's willingness to continue participation.
Provide literature citations and/or links to publications.
This field may also be used to communicate additional
information to the IRB that is pertinent to the review of
this SCR.
1-1 Study Risk Level
1-1.1 * Indicate the highest level of risks of harm to the
subjects resulting from the remaining portion of this
research?
No more than minimal risk
Minor increase over minimal risk
Moderate risk
High risk
1-2 Humanitarian Use Device New section in 1.6
(HUD)
1-2.1 * Characterize the ongoing activity:
Renewal: Device continues to be used clinically.
Renewal:Activity limited to clinical follow-up of the
device.
Termination Report. The study is completed; there is
no further subject recruitment, follow-up, or data
analysis.
1-2.2 * Number of patients and devices:
2.0 Approved Study Summary
2-2. Subject Enrollment Status
2-2.1 * Complete the highlighted column in the
following table with the total number of subjects that
have been enrolled at each performance site.
2-2.1.1 Explanation of discrepancies between
projected and actual enrollment progress:
2-2.2What is the total number of subjects to date that
were consented but were later determined ineligible
based on screening results? This does not include the
numbers you may be required to report to your
sponsor, such as the total number of potential subjects
approached.
2-4. Adverse Event (AE) and Other Reportable Information and Occurr
2-4.1 Individually-reported subject withdrawals to-date:
2-4.1.1 What are the total number of withdrawals that
have not been individually reported? (Use for large
minimal risk survey studies or UM coordinating site
reports)
2-4.2 Reported complaints to date:
2-4.4 Protocol deviations/violations to date:
2-4.5 Accidents/incidents involving data, specimens, or
facilities to date:
2-4.6 Reports from or to an oversight entity to date:
2-4.7 Pertinent publications/public announcements to
date:
3.0 Converted Study Information
3.1 * Prior to the conversion of this study to
eResearch, did the study design include the use of pre-
existing subject data, databases, data sets, medical
records, specimens from banks or repositories (i.e.,
secondary data analysis)?
3.2 * Prior to the conversion of this study to
eResearch, did the study design include the
recruitment and/or active participation of subjects in
order to produce new data (e.g., surveys, interaction,
intervention)?
3.3 Upload currently approved informed consent
documents:
3-2. Subject Enrollment Status - Converted Study
3-2.1 * Complete the highlighted column in the
following table with the total number of subjects that
have been enrolled at each performance site.
3-2.1.1 If subjects have been enrolled from additional
sites, list the sites and total number of adults and
children that have been enrolled at each site.
3-2.2What is the total number of subjects to date that
were consented but were later determined ineligible
based on screening results? This does not include the
numbers you may be required to report to your
sponsor, such as the total number of potential subjects
approached.
3-3. Amendments Summary
3-3.1 Since its last continuing review, the following
amendments have been submitted for this study via
eResearch:
3-3.2 * Since its last continuing review, describe any
amendments that have been approved for this study
that were submitted in the IRB‘s previous (―legacy‖)
system. Include reasons for the amendments and their
approval dates:
3-4. Adverse Event (AE) and Other Reportable Information and Occurr
3-4.1 List the individually-reported subject withdrawals
for this study not reported in eResearch. Include each
subject‘s withdrawal date, and reason for withdrawal:
3-4.1.1 If this study is a large, minimal-risk survey
study, or UM is only the coordinating site, what is the
total number of withdrawals that have not been
individually reported? In the table below, indicate the
total as of the this study‘s last scheduled continuing
review, and the total as of this continuing review.
3-4.2 Describe any reported complaints not reported in
eResearch. Include the date of complaint and its
current status:
3-4.3 Describe any internal UM adverse events not
reported in eResearch Include the date of the event, its
seriousness (i.e., mild, moderate, severe, life-
threatening, or fatal), relatedness, and expectedness:
3-4.4 Describe any protocol deviations/violations not
reported in eResearch. Include the date and type of
deviation/violation:
3-4.5 Describe any accidents/incidents involving data,
specimens, or facilities not reported in eResearch.
Include the date and type of incident (i.e., data,
specimen, facility):
3-4.6 Describe any reports from or to an oversight
entity not reported in eResearch. Include the date of
the report and the name of the oversight entity:
3-4.7Describe any pertinent publications/public
announcements not reported in eResearch. Include
the date and source of the publication/public
announcement:
Committee Specific Info Comments
new in release 1.6
new in release 1.6
If the original submission was a HUD
study the SCR will skip 1-1 taking the
PI to section 1-2
ormation and Occurrences (ORIO) Summary
ormation and Occurrences (ORIO) Summary
eResearch Application Questions and Logic as of 8/20/07
* indicates answer is required in eResearch Review eResearch Committee Comments
Routing: Program Specific
Branching Logic Info
1. General Study Information Required for all studies
1.1 * Study Title (limited to 256 characters):
1.1.1 Full Study Title (if applicable)
1.2 * Principal Investigator:
1.3 Study Team Members: (Note: PI is listed below and other study team members must be
added one at a time)
1.4 * Team Member: COI
1.5 * Function with respect to project: COI
1.6 * Allow this person to EDIT the application, including any supporting
documents/stipulations requested during the review process:
1.7 * Include this person on all correspondences regarding this application: (Note: This will
include all committee correspondence, decision outcomes, renewal notices, and adverse
event submissions. Co-investigators and faculty advisors are required to receive this
information.)
Conflict of Interest Detail: Required for PI, Co-Is and Faculty Advisors COI
C1 Do you receive income greater than $10,000/year or have any other significant financial COI
interest (stock, stock options, debt, security, or capital holdings, etc.) in or manage:
a business commercializing a product that the research is intended to evaluate or further
develop, or
a party whose financial interests would be directly and significantly affected by the research?
If yes, answer the following questions. COI
C1.1 Where have you submitted a disclosure of Conflict of Interest? COI COI
IRBMED or
COI OVPR
C1.2 Has a management plan been formalized? COI
C1.2.1 If yes, attach the management plan here. COI
C1.2.2 If no, describe the financial interest in sufficient detail to permit the IRB to determine COI
if such involvement represents a potential conflict-of-interest and/or should be disclosed to
potential research subjects in the informed consent form.
1.8 3rd party services: (e.g., transcriptionists, lab work, data analysis. etc.)
1.9 * Estimated Study Start Date: (mm/dd/yyyy)
1.10 * Estimated Study End Date: (mm/dd/yyyy)
1.11 * Select the appropriate IRB: Specific IRB
1.12 * Type of Application:
Research project involving human subjects, their data, and/or their specimens, including Requires 1-1
requests for exemption
Projects lacking immediate plans for involvement of human subjects, their data, and/or their Requires 1-2
specimens
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eResearch Application Questions and Logic as of 8/20/07
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Routing: Program Specific
Branching Logic Info
Facilitated Review Requires 1-1
Emergency one-time use of an investigational drug or biologic Requires 1-3
Emergency one-time use of an investigational or unapproved device Requires 1-4
Humanitarian Use Device (HUD) Requires 1-5
Facilitated Review (DO NOT SELECT-UNDER CONSTRUCTION) ONLY for
studies that
have already
been
approved by
the NIH NCI
Central IRB.
1-1. Standard Study Information Required for standard or faciliate review selected in 1.12
1-1.1 * Who initiated this study?
1-1.2 * This application is being submitted by a: Answer may
require Faculty
Advisor be named
1-1.2.1 Indicate course number here:
1-1.3 This study is currently associated with the following department. To associate this
research with a different department, click Select. If the department has defaulted to
"Student," click Select to specify the department through which this application is being
submitted.
1-1.4 * Has this study been previously disapproved by any UM or non-UM IRB?
1-1.4.1 If yes, list all IRBs.
Attach the IRB documentation outlining the previous review outcome.
1-1.5 Will the study utilize resources from the following centers? GCRC or
MADRC
1-1.6 * Does this study require review by the UM Health System Comprehensive Cancer Cancer Requires 1-6 and Added a new Cancer Center Program, Phase I
Center Protocol Review Committee or Cancer Prevention and Control Protocol Review Center PRC 3-2 unit, has been added.
Committee (PRC/CPC-PRC)? /CPC-PRC
1-1.7 * Has the scientific merit of this study already been peer reviewed (i.e., reviewed by
one or more recognized authorities on the subject)?
1-1.7.1 If yes, list the peer-review organization(s).
1-2. General Study Information - Project/Study Required for Projects lacking immediate plans for involvement of human subjects selected in
1.12
Lacking Immediate Plans for Involvement of
Human Subjects
1-2.1 This project/study is currently associated with the following department. To associate
this research with different department, click Select.
1-2.2 * Affirm that separate IRB approval will be obtained for any research study or activity
directly involving human subjects (or other identifiable information).
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eResearch Application Questions and Logic as of 8/20/07
* indicates answer is required in eResearch Review eResearch Committee Comments
Routing: Program Specific
Branching Logic Info
1-3. Emergency Use Drug or Biologic Information Required for Emergency use of drug or biologic selected in 1.12
1-3.1 * Provide the single-patient IND number:
1-3.3 * Describe the diseases or other indications for use of the emergency use drug or
biologic, including the justification for not enrolling the subject in an established research
study. Include a brief clinical history of the patient, including the diagnosis, the disease
status, prior therapy, response to prior therapy, and rationale for requesting the proposed
treatment.
1-3.4 * Describe proposed treatment plan, including the dose, route, planned duration,
monitoring procedures and modifications for toxicity. If appropriate, reference an IRB-
approved clinical protocol or journal publication.
Upload the referenced documents
1-3.5 * Describe the circumstances that led the physicians to conclude that this situation
constituted an emergency.
1-3.6 * Describe the signs and symptoms that led the physicians to conclude the patient was
facing a life-threatening or severely debilitating condition.
1-3.7 * Discuss why alternative therapies are unsatisfactory and why using the
investigational treatment has a greater likelihood of improving the patient‘s condition.
1-3.8 * Was or will consent be obtained before administration of the drug or biologic?
1-3.8.1 What type of informed consent process was or will be implemented prior to
administration or application of the test drug or biologic to the patient?
Upload a copy of the unsigned (to protect patient privacy) informed consent document here:
1-3.8.2 Affirm that the following circumstances prevented obtaining informed consent prior to
the administration of the drug or biologic.
Append a copy of the certification document prepared by the investigator and an impartial
physician.
1-3.9 * On what date did the administration or application of the test drug or biologic to the
patient begin, and when did, or will it end?
1-3.10 If the interval between the date of initial administration of the test drug or biologic and
the date of submission of this application is more than five days, what was the reason for the
delay in reporting?
1-3.11 * What information is available on the response of the patient‘s life-threatening
condition to the test drug or biologic at the time of this report?
1-4. Emergency Use Device Information Required for Emergency use of device selected in 1.12
1-4.1 * Provide the single-patient IDE number:
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eResearch Application Questions and Logic as of 8/20/07
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Routing: Program Specific
Branching Logic Info
1-4.3 * Describe the patient's condition and the circumstances necessitating treatment,
including the justification for not enrolling the subject in an established study. Include a brief
clinical history of the patient, including the diagnosis, the disease status, prior therapy,
response to prior therapy, and rationale for requesting the proposed treatment.
1-4.4 * Discuss why alternative therapies are unsatisfactory and why the probable risk of
using the investigational device is no greater than the probable risk from the disease or
condition.
1-4.5 * Describe any deviations from the approved clinical protocol that may be needed in
order to treat the patient. Provide IRB tracking number if the clinical protocol was approved
by a UM IRB. Clinical protocols approved by a non-UM IRB must be uploaded below.
Upload non-UM IRB approved clinical protocol here.
1-4.6 * Was or will consent be obtained before administration of the device?
1-4.6.1 What type of informed consent process was or will be implemented prior to
administration or application of the test article to the patient?
Upload a copy of the unsigned (to protect patient privacy) informed consent document here:
1-4.6.2 Affirm that the following circumstances prevented obtaining informed consent prior to
the administration of the test article.
Append a copy of the certification document prepared by the investigator and an impartial
physician.
1-4.7 * Provide the start and end dates of administration or application of the investigational
device to the patient.
1-4.8 * If the device has been administered, provide any information on the patient‘s
response.
1-5. Humanitarian Use Device Information Required for Humanitarian use of device selected in 1.12
1-5.1 * What is the name of the device? Include the generic and trade names as applicable.
1-5.2 * What is the source (supplier or manufacturer) of the device?
1-5.3 * What is the indication for use of the device?
1-5.4 * What are the alternative practices and procedures?
1-5.5 * What is the proposed mechanism of action of the device? Describe the device and
include any post-manufacturing modifications to the device.
1-5.6 * What is the frequency and total duration of use of the device?
1-5.7 * What are the contraindications, warnings, and precautions for the use of the device?
1-5.8 * Describe any foreseeable adverse effects of the device.
1-5.9 * What is the sponsor‘s risk designation for the device
1-5.10 * Date of HUD designation:
1-5.11 * HDE number:
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1-5.12 Attach the Humanitarian Device Exemption (HDE) documentation as provided by the
sponsor:
1-5.13 * Upload the unsigned informed consent document (to protect patient privacy) here:
1-5.14 * Affirm that the use of the HUD as described in this application will not contribute
data to any ongoing research project or clinical investigation. This does not preclude
reporting any FDA-required information to the manufacturer or sponsor of the HUD.
1-6. PRC/CPC PRC Information Requires if yes to 1-1.6
1-6.0 *Click ADD to attach scientific protocol electronically. PRC/CPC Added/updated text "Important information
PRC naming, editing, uploading, and downloading
documents.
Use the [Edit] function to upload a new version
of the document."
1-6.1 * Study Type: PRC/CPC
PRC
1-6.1.1 If Ancillary, Companion, or Correlative, please list associated studies. PRC/CPC
PRC
1-6.2 * Study Phase: PRC/CPC
PRC
1-6.3 * Does this trial require Cancer Center Resources (patients, space, CTO, biostatistics, PRC/CPC
IDS, CCCores)? PRC
1-6.3.1 For all unfunded and underfunded research studies requesting support, the CTRAC PRC/CPC
Application is available on the CTO Committee Website. Please complete this form and PRC
upload for review.
1-6.4 * Indicate needed Clinical Trials Office (CTO) resources. PRC/CPC
PRC
1-6.5 * Indicate the anatomic cancer site(s) (i.e. breast, ovary) on which the study is PRC/CPC
focused. PRC
1-6.6 * Indicate Cancer Center Research Program. Check all that apply. Required PRC/CPC
Cancer PRC
Center
Program
Directors
1-6.7 * Are there competing protocol(s)? PRC/CPC
PRC
1-6.7.1 If yes, please list protocol(s). PRC/CPC
PRC
2. Sponsor Information Required for all studies
2.1 External Sponsor(s)/Support:
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2.2 * Direct Sponsor/Support: Click Select to display the sponsor search engine. If your
sponsor is not listed in the search engine, enter it below.
2.2.1 * Sponsor Type:
2.2.2 * Support Type:
2.2.3 * Is the support confirmed?
2.2.4 DRDA #:
2.3 * Is this a subcontract to UM? If no, skip to question 2.4.
2.3.1 If yes, indicate the Prime Sponsor (the original source of funding): Click Select to
display the sponsor search engine. See Help for important instructions on conducting a
search.
2.3.2 Prime Sponsor Type:
2.3.3 Prime Support Type:
2.3.4 Is the Prime support confirmed?
2.4 Upload all of the following documents that apply:
Grant (*required for "Government - Federal" sponsor types)
Contract application (*required for "Government - Federal" sponsor types)
Sponsor budget (*required for use of GCRC resources)
Sponsor application
PAF
Most recent competing renewal application
2.5 Internal UM Sponsor(s): [Including department or PI discretionary funding]
2.6 * Department Sponsor/Support: Click Select to display the department search engine.
2.6.1 * Sponsor Type:
2.6.2 * Support Type:
2.6.3 * Is the support confirmed?
2.7 Upload Supporting Documentation
2.8 Check here if the proposed study does not require external or internal sponsorship or
support:
3. University of Michigan Study Functions Required for all studies except emergency and one time use studies
3.1 * Indicate all functions that will be performed at University of Michigan locations.
3-1. Performance Sites Required for all studies except emergency and one time use studies
3-1.1 * Based on the information provided in 3.1, "University of Michigan" is listed below as a
performace site. Click ADD to list non-UM locations (both domestic and foreign) where UM-
related research activities are conducted including subject recruitment, interaction,
intervention, study coordination, and/or data collection or analysis. Include all locations to
which identifiable private information may be sent. This section may or may not apply to
certain industry/corporate sponsor locations -- see Help for important instructions.
3-1.2 * Location or Institution:
3-1.3 Address:
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3-1.4 * Function of this location with respect to this study:
3-1.5 * Will this site be "engaged" in the conduct of the research? Note: "engaged" in this
context refers to the regulatory definition and NOT the use of the "Engage" portal website.
See Help for important information about responding to this question.
3-1.5.1 If yes, indicate the IRB or its regulatory equivalent that has reviewed or will review
this research and provide its approval.
3-1.6 If applicable, provide the Federalwide Assurance (FWA) number for this location.
(Note: If federally sponsored, FWA is required for site in addition to IRB approval.)
3-1.7 If applicable, indicate what organization, agency or government office has reviewed
this research and provided its approval (e.g. school district office, prison official, nursing
home administrator).
3-1.8 Upload any location site approval documentation here : IRB approval documention
and/or approval letters from the appropriate administrative authority (e.g, school district
office, prison official, nursing home administrator) as indicated above.
3-2. Cancer Center Subject Participation Requires if yes to 1-1.6
3-2.1 * Using the grid below, estimate the number of subjects at University of Michigan over PRC/CPC Validation rule has been corrected.
all of the years of the study. (populates 8-1.1.1) PRC
3-2.2 * Indicate the total number of subjects required from ALL study locations: (populates 1- PRC/CPC
1.1) PRC
3-2.3 * Is this a Multi-Institutional Study? PRC/CPC
PRC
3-2.3.1 If yes, indication the number of institutions involved in the study. PRC/CPC
PRC
4. Non-Technical Study Abstract Required for all studies
4.1 * Non-Technical Study Abstract (400 words or less): Use non-technical language that
someone without a scientific background could understand. Include a summary of the
significance, scientific objective or research question, and specific aims.
5. Research Design Required for standard or faciliate review selected in 1.12
5.1 * Is there a stand-alone scientific protocol document and/or research plan associated
with this application?
If yes, click ADD to attach the document(s) electronically, OR check below if the document is
not available electronically.
5.2 * Will the involvement of ANY subjects in this study be limited to analysis of their
existing data or specimens (other than any potential informed consent process, there will be
no DIRECT interaction/intervention with these subjects. Involvement for these subjects is
limited to analysis of subject data in existing databases, data sets, medical records, and/or
specimens from banks or repositories)?
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5.2.1 If yes, how many subjects are represented in the data or specimens to be analyzed
5.3 * Will the study involve recruitment and/or participation of subjects in order to produce Yes requires 7-1, Version 1.6: This is now required if Study team
new data (e.g., surveys, interaction, intervention)? [Require sections 8-3 and 11-3] 8-1, 8-3 and 11-3. answers yes to 1-1.5
5-1. Research Design
5-1.1 * Objective: What is the overall purpose of this research study? (Limit response to 1-2
sentences. If covered in attached document, indicate specific location. Failure to do so may
result in delays in the review process or return of the application.)
5-1.2 * Specific Aim(s): What is (are) the specific aim(s) of this study and/or what hypothesis
(hypotheses) is (are) to be tested? (If covered in attached document, indicate specific
location. Failure to do so may result in delays in the review process or return of the
application.)
5-1.3 * Background: What prior information or knowledge exists to support the conduct of
this study? (Limit response to 5,000 characters, including references. If covered in attached
document, indicate specific location. Failure to do so may result in delays in the review
process or return of the application.)
5-1.4 * Study team expertise: Briefly outline the special expertise and qualifications of the PI,
Co-Investigators and/or Faculty Advisors to conduct and/or oversee this particular study. (If
covered in attached document, indicate specific location. Failure to do so may result in
delays in the review process or return of the application. This will supplement information
provided in study team CVs.)
5-1.5 * Methodology: Describe the design and procedures to be used to accomplish the
specific aims of the study. Describe the advantages of any innovative methodologies.
Include a sequence or timetable of research activities. (If covered in attached document,
indicate specific location. Failure to do so may result in delays in the review process or
return of the application.)
5-1.6 * Statistical Design: Describe the statistical design of the research study, including
methods used to analyze data. Include (as appropriate) statistical or interpretive analysis
methods, study stopping rules, etc. (If covered in attached document, indicate specific
location. Failure to do so may result in delays in the review process or return of the
application.)
6. Benefits and Risks Required for standard or faciliate review selected in 1.12
6.1 * Are there potential direct benefits of this research to the subjects?
6.1.1 If yes, describe the potential direct benefits. Indicate if all, or only some, of the subject
groups may derive this potential benefit.
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6.2 * Describe the potential benefits of this research to society (e.g., how might the research
lead to improvement in management of a particular illness; health care cost reduction;
increased knowledge of a social issue; improved safety; better health; technological
advancement?).
6.3 * Provide a description of the foreseeable risks to the subjects (Rarely is a study
completely risk-free. Consider physical, psychological, social/reputation, legal, financial,
privacy risks, etc.)
For EACH identified risk, include:
likelihood of the risk,
seriousness to the subject; and
what measures will be taken to minimize the risk.
If possible, please use the following categories to assess the likelihood
―Common‖ (i.e., approximate incidence > 25%)
―Likely‖ (i.e., approximate incidence of 10-25%)
―Infrequent‖ (i.e., approximate incidence of 1-10%)
―Rare‖ (i.e., approximate incidence < 1%):
6.4 * Describe any direct risks to the public or community, which could result from this
research (e.g. potential dissemination to others of transferred genetic material, exposure of
others to radiation from radioisotopes administered to a subject.)?
6.5 * What is the highest level of risks of harm to the subjects, resulting from this research?
6.6 * Discuss why the risks to the subjects are reasonable in relation to the anticipated
benefits.
7. Special Considerations Required for standard or faciliate review selected in 1.12
7.1 * Does this study involve human tissue or biological specimens (use, collection, or Yes requires
secondary analysis) (e.g. blood, urine, bone marrow, skin, etc.)? [Require Section 18] Section 18
7.2 * Will genetic analysis be performed on any specimens acquired in conjunction with this Yes requires
study? [Require Section 20] Section 20
7.3 * Does this study involve the secondary analysis of a pre-existing data set, including Yes Requires
data associated with any specimens identified in response to question 7.1? (Studies that are Section 24
limited to retrospective review of medical records ARE considered secondary data analyses.
Consultation of medical record information in conjunction with a study involving
interaction/intervention (e.g., screening for eligibility) is not necessarily considered
secondary data analysis. In either case, a request for full or partial waiver of informed
consent and HIPAA authorization may be required.) [Require Section 24]
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7.4 * Will the research involve the access, collection, use, maintenance, or disclosure of Requires Section
University of Michigan protected health information (PHI)? PHI is: 25
information about a subject's past, present, or future physical or mental health, the provision
of healthcare to a subject, or payment for the provision of healthcare to a subject; AND that
is maintained by a University of Michigan school, department, division, or other unit that is
part of the University's HIPAA-covered component (e.g. healthcare provider, helathcare
plan, or healthcare clearinghouse).
(Answer ―yes‖ even if the information is de-identified or coded. See Help for a list of schools,
departments, or units that are part of the UM HIPAA-covered component) [Require Section
25]
7.5 * Is this study considered epidemiological or public health research? [Require Section Requires Section
26] 26
7.6 * Does this study involve UM-related research activities conducted or coordinated at Requires Section
sites outside of the United States? [Require Section 30] 30
7.7 * Is the intent of the study the development of a commercial product that may bring
financial benefit to the investigators and/or the University?
7-1. Special Considerations (continued) Required for all studies that involve direct interaction indicated in 5.3
7-1.1 * Will subjects receive payment or other incentives for their participation in the study? Requires Section
(e.g., free parking, course credit, health-care procedures provided at no charge, etc.) 13
[Require Section 13]
7-1.2 * Will subjects undergo healthcare-related treatments or procedures (standard of care Requires Section
and/or experimental) as part of the study (e.g., medical, dental, therapeutic, psychological, 14
etc.)? [Require Section 14]
7-1.3 * Does this study involve the deception of subjects? (I.e., the researcher intentionally Requires Section
does not reveal the whole truth to subjects, including elements of the informed consent 27
process. Research involving deception typically requires waiver or alteration of informed
consent, and a debriefing.) [Require Section 27]
7-1.4 * Excluding routine email correspondence, does this study involve the use of the Requires Section
Internet or email as an integral part of the research design or will sensitive information be 28
transmitted by e-mail? [Require Section 28]
7-1.5 * Will the study collect data using surveys, interviews, or focus groups? (e.g., collected Requires Section
from individuals, patients, households, businesses, organizations, etc.) [Require Section 29] 29
7-1.6 * Does this study require subjects to listen to an audio recording or view images (e.g. Requires Section
photographs, artwork, sketches, videos, etc.)? [Require Section 31] 31
7-1.7 * Will any drugs, biologics, nutritional (e.g., herbal or alternative medication) Requires Section
supplements or other material be administered, implanted, or applied to the subjects as the 15
object of the study? (Please note, a fee applies if using UMHS IDS services) [Require
Section 15]
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7-1.8 * Will the study involve a placebo (drug, device, procedure, intervention, surgery, etc.) Requires Section
control group? [Require Section 17] 17
7-1.8.1 If yes, is the placebo for a drug? [Require Section 15] Require Section
15
7-1.9 * Will the study involve human embryonic stem cells (hESCs), human embryonic germ Require Section
cells derived from fetal tissue, or hESC- or germ cell-derived test articles? [Require Section 19
19]
7-1.10 * Will the study have a Data and Safety Monitoring Plan (DSMP)? A DSMP is Require Section
required for: 32
GCRC-sponsored research,
FDA-regulated research,
Research where adverse events (AEs) are expected (e.g., physical, social, psychological,
confidentiality/privacy, etc. and
NIH-sponsored research involving human subjects.
Note: For Dental School Applications, See Help for more information. [Require Section 32]
7-2. Special Considerations (continued) Required for all IRBMED, Health, and Flint IRB studies indicated in 1.11 that involve direct
interaction indicated in 5.3
7-2.1 * Will any clinical devices be used, administered, implanted, or applied to Require Section
the subjects?[Require Section 16] 16
7-2.2 * Will the subjects be exposed to any ionizing radiation during the course of this study? Require Section
(e.g., x-rays, CT-scans, PET-scans, beta-rays, gamma-rays, neutrons, and other high-speed 21
atomic particles. Magnetic Resonance Imaging (MRI) is NOT ionizing radiation.) [Require
Section 21]
7-2.3 * Will any organs, tissues, or cells from other humans (including fetal tissue) or Require Section
animals be administered to the subjects for the purposes of this study? [Require Section 22] 22
7-2.4 * Does this study involve a gene transfer intervention or an intervention based on Require Section
recombinant DNA technology? [Require Section 23] 23
8. Subject Description
In Section 5 - Research Design, the following information was provided about subject
involvement:
8.1 * List the inclusion and exclusion criteria for this study population and/or data set. (If
covered in attached protocol, indicate section)
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8.2 * Indicate the age range (in years) of the subject population in this study. Use age to
Minimum Age: idetermine
Maximum Age: whether 10 Adults
or Minor Informed
Consent pages
are required
8-1. Subject Participation Required for all studies that involve direct interaction indicated in 5.3
8-1.1 * Please indicate the number of subjects required (from ALL study sources, sites, and
locations combined) to achieve the goal of the study (the statistical "n" of the study):
8-1.1.1 * Of the number provided in 8-1.1, indicate the number of subjects from performance
sites where UM-related research activities are conducted (see list of sites in 8-1.2, below).
8-1.2 * Apportion the number provided in question 8-1.1.1 using the grid below. This will
represent the estimated number of subjects required from each site where UM-related
activities are to be conducted, over all of the years of the study. To modify this list of study
locations, use the "Jump To" list at the top of the page and return to Section "03-1.
Performance Sites" before completing this section.
8-1.3 * Will subjects' ethnic, racial, or gender information be recorded? This is a
requirement for studies utilizing General Clinical Resource Center (GCRC) resources, and
for other NIH-funded studies.
8-1.3.1 For GCRC and/or NIH-funded studies, please complete the NIH Targeted/Planned
Enrollment Table, summarizing enrollment for all sites where UM-related activities are to be
conducted, over all of the years of the study. The Ethnic Category Total of all Subjects and
the Racial Category Total of all Subjects must be equal. See Help for regional and national
demographic information. Enter values in whole numbers, not percentages. TABLE
INCLUDED: Ethinic Category1: Hispanic or Latino, Non-Hispanic and Non-Latino, Ethinic
category: Total of All Subjects. Racial Category: American Indian/Alaska Native, Asian,
Native Hawaiian or Other Pacific Islander, Black or African American, White,
RacialCategory: Total of All Subjects
8-1.3.2 Identify any racial, ethnic, or gender group(s) that will be specifically excluded from
participation in this research study and provide a compelling justification for such exclusion:
8-2. GCRC Subject Participation Required for all studies that involve direct interaction indicated in 5.3 and GCRC is selected in
1-1.5
8-2.1 * What are the proposed dates of enrollment, including timeframe and expected GCRC
dates?
8-2.2 Inclusion of Women GCRC
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8-2.2.1 * Provide a description of the subject selection criteria and rationale for selection in GCRC
terms of the scientific objectives and proposed study design as it relates to the inclusion of
women.
8-2.2.2 * Provide a description of proposed outreach programs for recruiting women in GCRC
clinical research as subjects.
8-2.3 Inclusion of Minorities GCRC
8-2.3.1 * Provide a description of the subject selection criteria and rationale for selection in GCRC
terms of the scientific objectives and proposed study design as it relates to the inclusion of
minorities.
8-2.3.2 * Provide a description of proposed outreach programs for recruiting minorities in GCRC
clinical research as subjects.
8-2.4 * Are children (under 18 years) excluded from the study GCRC
8-2.4.1 Which of the following NIH reasons apply to the exclusion of children in the proposed GCRC
study?
8-2.4.2 Explain the justification for the exclusion of children. GCRC
8-3. Subject Recruitment Required for all studies that involve direct interaction indicated in 5.3
8-3.1 * Indicate which of the following established subject pools, if any, will be used for
recruitment. The following is not an exhaustive list. If an established subject pool will be
used but does not appear in this list, check "other" and describe it below. If no established
subject pools will be used, check "N/A."
Children at their preschool, elementary, middle, or high school location
UM Ann Arbor Introductory Psychology Pool
UM Dearborn Introductory Psychology Pool
UM Flint Introductory Psychology Pool
UM Housing Residents/Student Dorms
UM Human Research Recruiting Registry (e.g., Engage –
http://www.med.umich.edu/engage/)
Department or unit-specific research recruiting registry (provide UM IRB project number
below)
Other UM subject pools (describe below)
Patients or their medical records from the UM Health System or any other UM health care
provider (e.g., School of Dentistry, University Health Service, University Center for
Language and Literacy)
M-CARE, M-CAID, MHIC or MHMC members Patients of non-UM physicians, dentists, or
other health care providers or facilities
N/A
Provide Related UM IRB Project Number or Subject Pool Description:
8-3.2 * Describe the location and manner in which potential study subjects will be
recruited.List specific locations (e.g., Taubman Center, Cancer Center, Briarwood Mall).
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8-3.2.1 If applicable, how will prospective subjects' healthcare providers (e.g., physician,
dentist, etc.) be involved in the recruitment and/or be notified of their individual patients'
participation in the study?
8-3.3 * Explain how the recruitment strategy is equitable and represents the population
required for the study. If the information is covered in the attached protocol, please indicate
section.
8-3.4 * Does the recruitment strategy involve contacting individuals multiple times in an
effort to secure their initial enrollment into the study?
8-3.4.1 If yes, describe how frequently and in what manner individuals will be contacted. If
the information is covered in the attached protocol, please indicate section.
8-3.5 * Indicate which methods will be used for recruitment?
8-3.5.1 * Estimate the total number of individuals and/or households that will be contacted in
the recruitment effort for all phases of the study. See Help for important information about
responding to this question.
8-3.5.2 How will any email, address, and/or telephone lists be obtained?
8-3.6 * What materials will be used for recruitment? The IRB must approve all recruitment
materials.
If Web pages will be used, provide the Web address (URL) for the location where the pages
will be posted (also upload the content of the pages below):
Upload recruitment materials here:
9. Survey Populations Required for all studies that involve direct interaction indicated in 5.3 and yes to 7-1.5
9.1 * Is the study limited to a survey of either:
The general adult population (aged 18 or older); or
A subgroup of the general population which does not specifically target
Pregnant women and/or fetuses
Lactating women
Women of child-bearing potential
Prisoners
Cognitively impaired adults
College students
Economically or educationally disadvantaged persons
Patients of the study team
Employees, students or trainees of the study team
Family members of the study team
where the survey is the sole interaction with the subject and does not pose more than
minimal risk? (Interaction includes communication or interpersonal contact between the
subject and the investigator.)
9-1. Subject Populations Required for all standard and facilitated review studies in Release 1.5 unless 9.1=yes
9-1.1 Is the research designed to include or allow the following populations?
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Normal, healthy subjects
Adults age 18 and older
Emancipated Minors under the age of 18 that have been granted adult status by the courts
Children (Minors under the age of 18) [Require Sections 33 and 41 or Section 33-1 for Requires Sections
analysis only studies] 33 and 41 for
studies that
involve direct
interaction
(5.3=Yes).
Requires 33-1 for
analysis only
studies studies
(5.2=Yes and
5.3=No)
Viable neonates [Require Sections 33 and 41 or Section 33-1 for analysis only studies.] Requires Sections
33 and 41 for
studies that
involve direct
interaction
(5.3=Yes).
Requires 33-1 for
analysis only
studies studies
(5.2=Yes and
5.3=No)
Neonates of uncertain viability and/or non-viable neonates (do not check this box if the Requires Section
research is solely retrospective. For retrospective research regarding neonates of uncertain 34 for all studies
viability, check the box for 'children'. See Help for additional information.) [Require Section
34.]
Individuals and/or products involving human in-vitro fertilization
Pregnant women and/or fetuses [Require Sections 35 and 41or Section 35-1 for analysis Requires Sections
only studies] 35 and 41 for
studies that
involve direct
interaction
(5.3=Yes).
Requires 35-1 for
analysis only
studies studies
(5.2=Yes and
5.3=No)
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Lactating women [Require Section 36 studies involving interaction/intervention.] Requires Section
36 for studies that
involve direct
interaction
(5.3=Yes).
Women of child-bearing potential [Require Section 37 studies involving Requires Sections
interaction/intervention] 37 for studies that
involve direct
interaction
(5.3=Yes).
Prisoners (If the research includes a study population that is likely to become incarcerated Requires Section
during the conduct of the research, also select this category) [Require Section 38 for all 38 for all studies.
studies. Require Sections 38 and 41 for studies involving interaction/intervention] Requires Section
41 for studies that
involve direct
interaction
(5.3=Yes).
Cognitively impaired adults [Require Sections 39 and 41 studies involving Requires Sections
interaction/intervention.] 39 and 41 for
studies that
involve direct
interaction
(5.3=Yes).
College students [Require Sections 40 and 41 for direct interaction studies] Requires Sections
40 and 41 for
studies that
involve direct
interaction
(5.3=Yes).
Economically or educationally disadvantaged persons [Require Section 41 for direct Requires Section
interaction studies.] 41 for studies that
involve direct
interaction
(5.3=Yes).
Patients of the study team [Require Section 41 for direct interaction studies] Requires Section
41 for studies that
involve direct
interaction
(5.3=Yes).
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Employees, students or trainees of the study team [Require Section 41 studies involving Requires Section
interaction/intervention.] 41 for studies that
involve direct
interaction
(5.3=Yes).
Family members of the study team [Require Section 41 studies involving Requires Section
interaction/intervention] 41 for studies that
involve direct
interaction
(5.3=Yes).
Unknown, unspecified population
10. Informed Consent - Adults Required if subject maximum age > 17 or Emancipated minors are subject population
10.1 * What type of informed consent will be obtained from adults or emancipated minors? Answer
See Help for important instructions on selecting the appropriate category. determines
required Informed
Consent sections
10.1.1 * Describe the process to seek and obtain informed consent from adults (e.g., setting,
timing, personnel involved, arrangements for answering subject questions before and after
the consent is signed).
10.1.2 * Is the cognitive capacity of the subjects expected to change significantly during the
study?
10.1.2.1 If yes, describe the plan to re-consent the subject or the subject‘s legally authorized
representative after the change in the cognitive capacity of the subject.
10. Informed Assent for Children and Parental or Required if subject minimum age < 18
Guardian Consent/Permission
10.2 * What types of informed assent for children and parental consent/permission will be Answer
obtained? determines
NOTE 'Parent' or 'Parental' below refers to parent or guardian. See Help for important required Informed
instructions on selecting the appropriate category. Consent sections
10.2.1 * Describe the process to seek and obtain informed assent for children and parental
consent/permission (e.g., setting, timing, personnel involved, arrangements for answering
subject questions before and after the consent is signed).
10.2.2 * What criteria will be used to determine whether or not a child‘s assent to participate
will be obtained, whether that assent will be oral or written, and whether documentation of
the child's assent (e.g., signature on the assent form) will be obtained?
10.2.3 * Are any of the following changes expected in the status of child subjects during the
study?
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10.2.3.1 If applicable, describe the plan to re-assent or obtain consent for the subject if any
of the changes occur.
10-1. Informed Consent Required if any informed consent is selected in either 10.1 or 10.2
10-1.1 * Upload all informed consent, assent, permission, and/or debriefing documents: Added/updated text "Important information
naming, editing, uploading, and downloading
documents.
Use the [Edit] function to upload a new version
of the document."
Informed consent documents must contain
merge fields.
10-1.2 * Will the subjects be audiotaped, videotaped, or photographed; or will recognizable
images of subjects be recorded during the research?
10-1.2.1 If yes, confirm that any required informed consent document(s) and/or debriefing
document(s) seek explicit permission (e.g., separate signature) to record the subjects and/or
use the materials for the purpose of this research.
10-1.3 * Is there a substantial likelihood that the research will be conducted among a non-
English-speaking population?
10-1.3.1 If yes, identify the language(s) expected to be encountered:
10-1.4 * Indicate which anticipated costs could be the full or partial responsibility of the
subject.
Cost of routine health care that would be incurred for this condition if the subject were not
participating in the research studyNo anticipated costs
Parking
Travel
Lodging
Lost wages
Research-related services/procedures
Research-related counseling
Drugs, biologics, or devices
Other
10-1.5 * Is the study designed to collect identifiable information from primary research Requires 10-2
subjects about other individuals (including family members) ?
10-2. Informed Consent for Other Individuals Required if yes to 10-1.5
10-2.1 * What specific information will be collected about other individuals (including family
members)?
10-2.2 * How will these individuals be referenced in the research record (e.g., full names,
addresses, relationship to subject, unique identifiers, etc.)?
10-2.3 * Will informed consent be obtained from these individuals?
10-2.3.1 If yes, describe the plan to contact the individuals to obtain consent.
10-3. Informed Consent Waiver Required if waiver of informed consent is selected in either 10.1 or 10.2
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10-3.1 * This request is for:
10-3.1.1 If this request is for PART of the project, identify the specific research procedures
(e.g., screening interview) and/or the specific subject populations (e.g., parents of child-
subjects) involved.
10-3.1.2 Explain any requested alterations to the informed consent process.
10-3.2 Check below to affirm that this study meets each of the following four criteria for
waiver or alteration of informed consent and explain how:
10-3.2.1 * The research involves no more than minimal risk to the subjects.
10-3.2.2 * The waiver or alteration will not adversely affect the rights and welfare of the
subjects.
10-3.2.3 * Research could not practicably (i.e., feasibly) be carried out without the waiver or
alteration.
10-3.2.4 * Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
10-4. Informed Consent Documentation Waiver Required if waiver of documentation of informed consent is selected in either 10.1 or 10.2
10-4.1 * This is a request for a waiver of documentation of informed consent for the following
reason:
10-4.2 * Is this a request for a waiver of the requirement to obtain informed consent for all Changed the wording in question 10-4.2 to "Is
research procedures and all subject populations? this a request for a waiver of documentation of
informed consent.....
10-4.2.1 If no, identify the specific research procedures (e.g., screening interview) and/or the
specific subject populations (e.g., parents of child subjects) for which a waiver of
documentation is being requested.
10-5. Exempt Study -- Informed Consent Required if exempt informed consent is selected in either 10.1 or 10.2
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Completion of this section is required based on the response provided to question 10.1
indicating that the study itself is exempt (i.e. it falls into one of the categories of research
listed in section 12 of this application).
Although federal regulations do not require consent for exempt research there may be an
ethical imperative to obtain consent, depending on the nature of the research. The IRB may
require consent before granting an exemption. If consent will be sought, regardless of
whether a signature or other documentation of consent will be sought, upload a copy of the
proposed document or script.
If consent or assent will not be sought click the continue button to skip this section.
Examples of other documentation of consent include but are not limited to: cover letter,
introductory statement in a survey, telephone or in-person invitation-to-participate script,
information sheet.
See Help for important information about exemptions and waivers.
11. Confidentiality/Security Required for standard or faciliate review selected in 1.12
11.1 * Will any component of the research involve data that is linked to a subject's identity by
name or other identifier or code?
11.2 * How will the research records and data be protected against inappropriate use or
disclosure, or malicious or accidental loss or destruction? Records and data include
informed consent documents, case report forms or study flow sheets, survey instruments,
database or spreadsheet, screening logs or telephone eligibility sheets, web based
information gathering tool, audio/video/photo recordings of subjects, labeled specimens,
data about subjects, subject identifiers, etc.
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Locked office
Locked cabinet or storage unit
Restricted access
Destruction of source data immediately after data collection (e.g., to preserve anonymity of a
vulnerable population)
Restrictions on copying study-related materials
Access rights terminated when authorized users leave the project or unit
Secure laptop
Individual ID plus password protection
Routine electronic back up
Disaster recovery plan
Encryption of digital data
Network restrictions
No non-UM devices are used to access project data, or any that are used to access project
data use secure connections to communicate with U-M services (e.g. VPN – ―virtual private
network‖)
Security software (firewall, anti-virus, anti-intrusion) is installed and regularly updated on all
servers, workstations, laptops, and other devices used in the project
Safe disposition/destruction of data or devices, as appropriate (e.g., shredding paper
documents, destroying disks or thumb drives, secure erasure of electronic media)
Additional protective measures or special circumstances
11.2.1 Describe any additional measures that will be taken to protect the study records and
identifiers from improper use and disclosure or malicious or accidental loss or destruction.
11.3 * Will the research generate information which, if revealed, might place the subjects at
risk of personal safety, criminal or civil liability, or damage to their financial standing,
employability, or reputation? (e.g. sexual matters, use of alcohol or drugs, stigmatizing or
discriminating medical or mental health information) [Require Section 11-2]
11.4 * What will happen to the data and/or any specimens at the conclusion of this study? Require 11-4 if
Bank/Repository
is selected
11.4.1 If the data and/or specimens will be destroyed, describe the specific plan that will be
employed following the required retention period (e.g., destruction of research records;
removal of identifiers; destruction of linkage code information). If the information is covered
in the attached protocol, please indicate section.
11.4.2 If the data and/or specimens will be retained for study recordkeeping purposes,
describe the storage arrangements (e.g., expected duration, location, security, storage
conditions, and monitoring). If the information is covered in the attached protocol, please
indicate section.
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11-1. Identifiable Data Completion of this section is required based on the response provided to question 11.1.
11-1.1 * Indicate how subjects are identified in the research records:
Directly -- stored on data record (e.g., name, initials, phone number, SSN, or medical
record number, stored on data record)
Indirectly -- linked to data record but stored separately (e.g., name, initials, phone number,
SSN, or medical record number linked to data record but stored separately)
11-1.2 * Explain the necessity for collecting or maintaining data linked to subjects' identities.
If the information is covered in the attached protocol, please indicate section.
11-1.3 * How long will the identifiers be retained?
11-1.4 * Will individually identifiable sensitive data be accessed collected, used, maintained, Privacy
or disclosed in the study? Sensitive data is defined in the University‘s Standard Practice Office
Guide, SPG #601.12. It includes personal identifiable information about employees,
students, and patients of the University.
11-1.4.1 Will a continuous, periodic, or automatic feed of sensitive data be set up to provide Send notice Privacy
data directly from any University information system (e.g., M-Pathways, U-M Data to Privacy Office
Warehouse, CareWeb)? Board if yes
and 25.1
has any
answer
other than
"None of the
above"
If yes, list each of the systems involved and briefly describe the data feed and reasons it is Privacy
needed: Office
11-1.4.2 Will sensitive data be accessed by individuals who are not University employees? Privacy
Office
11-1.4.3 Will sensitive data be stored on or accessed from computer equipment that is not Privacy
maintained and supported by a University IT services provider (e.g., MAIS, MCIT, MSIS) – Office
such as home computers, grant-funded computers, etc.?
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11-1.4.4 Will sensitive data be stored on portable devices (e.g., laptops, PDAs, flash drives) Send notice Privacy
in unencrypted form? to Privacy Office
Board if yes
and 25.1
has any
answer
other than
"None of the
above"
11-2. Certificate of Confidentiality Completion of this section is required based on the response provided to question 11.3.
11-2.1 Will a Certificate of Confidentiality be obtained for this research?
If yes, upload the certificate here.
Check here if the Certificate of Confidentiality is pending.
Note: All obtained Certificates must be forwarded to the Office of the Vice President for
Research for signature by an appropriate institutional official. Principal investigators are not
authorized signers.
11-2.2 Describe any measures or procedures, other than those listed in response to
question 11.2, that will be employed to prevent others from learning about subjects'
participation in this study.
11-3. End of Subject Participation Required for all studies that involve direct interaction indicated in 5.3
11-3.1 * What specific criteria will be used to prematurely end a particular subject's
participation in the study (e.g., predetermined safety endpoints, unexpected clinically
significant findings, situations of distress or adverse events)? (If covered in attached
protocol or informed consent, indicate specific location. Failure to do so may result in delays
in the review process or return of the application.)
11-3.2 * If a participant withdraws from the research, what is the plan to use, disclose, store,
or destroy the participant's data?
11-4. Bank/Repository Detail Required if create bank/repository selected in 11.4
11-4.1 * What is the intent or purpose of this bank or repository?
11-4.2 * Where will the data/specimens be stored?
11-4.3 * Describe the arrangements for the storage conditions, management, and security of
the bank/repository. Include the following as applicable:
Personnel access to data/samples
Whether identifiers will be removed or code/key destroyed to anonymize the samples.
For keyed samples, indicate who holds secondary codes/keys
Storage plan
Plan to protect privacy in transfer to other collaborators.
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11-4.4 * Does the informed consent document notify the subject that their data/specimens
will be stored in a bank or repository for future research?
11-4.5 * Is the subject required to participate in the bank or repository as a condition of
participating in the research?
11-4.5.1 If yes, provide a justification for conditioning participation in the research on
inclusion of data or specimens in the bank or repository. If the information is included in the
attached protocol, please indicate section.
12. Exemption Required for standard or faciliate review selected in 1.12 unless Prisoners have been selected
in 9-1.1
12.1 * Does the proposed research study qualify for exempt IRB review status?
12.1.1 If yes, which of the following six exemption criteria applies to the study? New EXEMPTION #7:
category in Research in which study activity is limited to
1.6 analysis of identifiable data. For purposes of
this research study, all research subject
interactions and interventions have been
completed and the data continues to contain
subject identifiers or links. The Research is not
federally-funded, regulated by the FDA or
conducted under a Certificate of Confidentiality.
(This category is for IRB Health and IRB
Behavioral Sciences use only.)
13. Subject Payments Or Other Incentives Required if yes to 7-1.1
13.1 * Indicate all payments or other incentives provided to subjects for their participation in
this study:
13.2 * If the subject is a child (under the age of 18 in Michigan), are any of the payments or
incentives intended for the parent/guardian of the child?
13.3 * Describe the amount and the frequency of the payments or incentives. If applicable,
list any healthcare procedure(s) that will be provided to subjects at no charge.
13.4 * What is the justification for offering these payments or incentives?
13.5 * What is the plan to compensate subjects withdrawing from the research prior to
completing the entire study.
14. Healthcare-Related Treatments and Procedures Required if yes to 7-1.2
14.1 * Check any of the following UM facilities that will be used in the study. Note: this list
represents only units with special reporting needs. If none of these facilities are used in the
research, check "None of the above."
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14.2 * List or briefly describe both the healthcare and experimental treatments/procedures
that will be performed in conjunction with this study. (If covered in attached protocol, please
indicate section.)
14.3 * Will any standard or commonly accepted treatments/procedures be modified for the
purposes of this study?
14.3.1 If yes, describe the treatments/procedures and how they will be modified. (If included
in an attached protocol, indicate section.)
14.4 If any study treatments/procedures require special skills (e.g., cancer chemotherapy,
arterial cannulation, tissue biopsy, etc.), identify the treatment(s)/procedure(s) and the
personnel qualified to perform them.
14.5 * Will subjects be billed/charged for the costs of any study-related healthcare
treatments or procedures not covered by the study or a third party payer?
14.5.1 If yes, list the treatments or procedures unlikely to be covered.
14.6 * Will any standard treatment/procedure be withheld or withdrawn from subjects for the
purposes of the study?
14.6.1 Describe the standard treatment/procedure that will be withheld or withdrawn from
subjects of this study.
14.6.2 Provide a justification for withholding or discontinuing the standard
treatment/procedure for the purpose of study participation.
14.6.3 How will these subjects be monitored and/or managed?
14.7 * What action will be taken in the event that a potentially significant, unexpected
disease or condition is identified incidental to a study treatment or procedure? (e.g.
discovery of a tumor during fMRI scans for a psychological study)
14.8 * In the event that a subject experiences a health emergency, what arrangements have
been made for the subject‘s healthcare provider (e.g., physician, dentist, psychologist, etc.)
to obtain important information about the study or contact the study investigator(s)?
14.9 * Do any of the study treatments/procedures pose a risk of causing birth defects or Version 1.6: An answer of possibly or definitely
genetic mutations that could lead to birth defects? and unknown require either 14.9.1 or 14.9.2
are answered.
14.9.1 List the study treatments/procedures that could pose a risk of genetic mutations or
birth defects.
14.9.2 Describe the pregnancy preventative measures that will be required for both men and
women, and specify the duration of the preventative measures.
15. Drugs, Biologics, Nutritional Supplements or Required if yes to 7-1.7 or 7-1.8.1
Other Products
15.1 * Indicate the drug trial phase as assigned by the FDA for this research study:
15.2 * What unit will be responsible for storing and dispensing the agent(s)? IDS May require 15-1
15.2.1 If waiver of IDS involvement is being requested, explain below:
15.3 * List all agents that are administered as the object of the study or that are relevant to
the study.
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15.3.1 Agents not approved by the FDA:
15.3.2 * What is the generic name or descriptor of the product (drug, biologic)? Include trade
names if available.
15.3.3 * The product being used or evaluated is a:
15.3.4 * What is the source of the product? Include both supplier and manufacturer if
different.
15.3.5 * Does the product need to be compounded from raw material? IDS
If yes, answer the following three questions. If no, jump to 15.3.6. IDS
15.3.5.1 Attach Certificate of Analysis and Material Safety Data Sheet (MSDS). IDS
15.3.5.2 Where and how will compounding take place and by whom? IDS
15.3.5.3 Attach step-by-step preparation instructions including information about sterility IDS
testing, stability testing, pyrogen testing, and record keeping. (Providing only a reference is
not sufficient.)
15.3.6 * What is the proposed mechanism of action of the product? Include any post-
manufacturing modifications to the product expected to affect the proposed mechanism of
action.
15.3.7 * What is the dosage, route of administration or application, and frequency and total
duration of use of the product?
15.3.8 If this research is NOT being conducted under an IND (Investigational New Drug)
application, provide a justification why an IND is not required.
Upload determination from FDA that no IND is required:
If this research is being conducted under an IND (Investigational New Drug) application,
answer all remaining questions. If no IND is required, scroll to the bottom of the page and
click OK.
15.3.9 What is the IND number?
15.3.10 Who holds the IND?
15.3.11 FDA IND Documentation/Investigator's Brochure: For an investigator-sponsored
IND (an IND submitted to the FDA by a University investigator) submit a copy of the IND
application and subsequent FDA correspondence, including any amendments.
For a manufacturer-sponsored IND, submit copies of the manufacturer‘s investigator‘s
brochure or comparable document.
15.3.12 Has a Drug Master File been established for this experimental biopharmaceutical? IBC
15.3.12.1 If yes, what is the Drug Master File number? IBC
15.3.12.2 Who is responsible for Quality Assurance and the annual Drug Master File IBC
updates to the FDA? (University of Michigan or the sponsoring company - please specify the
name of the company.)
15.3.13 Will subjects, or their insurance providers, be charged for the investigational
drug/biologic?
15.3.13.1 If yes, provide documentation that the FDA has given approval for the sponsor of
this research study to charge subject or their insurance providors for the investigational
drug/biologic.
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15.3.14 FDA-approved agents used "off-label" (i.e., in an unapproved dose, route of
administration, population, disease, in concomitant medical use, etc.):
15.3.15 * What is the generic name or descriptor of the product (drug, biologic)? Include
trade names if available.
15.3.16 * The product being used or evaluated is a:
15.3.17 * What is the source of the product? Include both supplier and manufacturer if
different.
15.3.18 * Does the product need to be compounded from raw material? IDS
If yes, answer the following three questions. If no, jump to 15.3.6. IDS
15.3.18.1 Attach Certificate of Analysis and Material Safety Data Sheet (MSDS). IDS
15.3.18.2 Where and how will compounding take place and by whom? IDS
15.3.18.3 Attach step-by-step preparation instructions including information about sterility IDS
testing, stability testing, pyrogen testing, and record keeping.
15.3.19 * What is the proposed mechanism of action of the product? Include any post-
manufacturing modifications to the product expected to affect the proposed mechanism of
action.
15.3.20 * What is the dosage, route of administration or application, and frequency and total
duration of use of the product?
15.3.21 * Briefly describe how the research use departs from the FDA approved indication.
15.3.22 * Describe the purpose of the ―off-label‖ evaluation (e.g. to support a new indication
for the use of the drug, to support any other significant change in the labeling or advertising
for the drug, etc.).
15.3.23 If this research is NOT being conducted under an IND (Investigational New Drug) Added validation: must answer this question
application, provide a justification why an IND is not required. OR 15.3.24
Upload determination from FDA that no IND is required:
If this research is being conducted under an IND (Investigational New Drug) application,
answer all remaining questions. If no IND is required, scroll to the bottom of the page and
click OK.
15.3.24 What is the IND number? Added validation: must answer this question
OR 15.3.23
15.3.25 Who holds the IND?
15.3.26 FDA IND Documentation: For an investigator-sponsored IND (an IND submitted to
the FDA by a University investigator) submit a copy of the IND application and subsequent
FDA correspondence, including any amendments. For a manufacturer-sponsored IND,
submit copies of the manufacturer‘s investigator‘s brochure or comparable document.
15.3.27 Has a Drug Master File been established for this experimental biopharmaceutical? If IBC
yes, answer the following two questions. If no, skip to 15.3.28
15.3.27.1 If yes, what is the Drug Master File number? IBC
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15.3.27.2 Who is responsible for Quality Assurance and the annual Drug Master File IBC
updates to the FDA? (University of Michigan or the sponsoring company - please specify the
name of the company.)
15.3.28 Will subjects, or their insurance providers, be charged for the investigational
drug/biologic?
15.3.28.1 If yes, provide documentation that the FDA has given approval for the sponsor of
this research study to charge subject or their insurance providors for the investigational
drug/biologic.
15.3.29 FDA-approved agents:
15.3.30 * What is the generic name or descriptor of the product (drug, biologic)? Include
trade names if available.
15.3.31 * The product being used or evaluated is a:
15.3.32* What is the source of the product? Include both supplier and manufacturer if
different.
15.3.33 * Does the product need to be manipulated or compounded?
If yes, answer the following three questions. If no, jump to 15.3.34.
15.3.33.1 Attach manufacturer's package insert. .
15.3.33.2 Where and how will compounding take place and by whom?
15.3.33.3 Attach step-by-step preparation instructions including information about sterility
testing, stability testing, pyrogen testing, and record keeping. (Providing only a reference is
not sufficient.)
15.3.34 * What is the proposed mechanism of action of the product? Include any post-
manufacturing modifications to the product expected to affect the proposed mechanism of
action.
15.3.35 * What is the dosage, route of administration or application, and frequency and total
duration of use of the product?
15.3.36 * Will subjects, or their insurance providers, be charged for the use of the
drug/biologic?
15.4 For outpatients, will Home Care services be required:
15.4.1 Home care services will be covered by:
15-1. Investigational Drug Service (IDS) Required if IDS selected in 7-1.2
Information
15-1.1 * List authorized prescriber(s)/phone/page: IDS
15-1.2 * List division administrator/phone/address: To obtain grant account # for dispensing IDS
fees
15-1.3 * Total number of subjects expected at U-M: IDS
Indicate the patient status of the subjects. IDS
15-1.4 * When will drugs need to be dispensed? IDS
15-1.5 * Drug source: IDS
15-1.6 List drugs (including placebo) supplied by sponsor: IDS
15-1.7 * Drug sponsor contact name and phone: IDS
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15-1.8 List drugs you need IDS to purchase (using study account) from regular pharmacy IDS
channels:
15-1.9 Indicate how IDS services and dispensing fees will be covered. (Grant, department IDS
funds, sponsor, GCRC, etc.) Contact IDS to determine IDS service and dispensing fees.
15-1.10 Indicate whether study drug needs to be compounded (outside of standard IDS
preparation of drugs) by pharmacy.
15-1.11 Provide study monitor name and phone (if known): IDS
15-1.12 * What is the duration of patient recruitment? IDS
15-1.13 * What is the duration of patient drug treatment? (If open-ended, estimate the IDS
average duration of treatment.)
16. Device Required if yes to 7-2.1
16.1 * What unit will be responsible for labeling, storing and dispensing the device(s)?
16.2 * List all agents that are administered as the object of the study or are relevant to the
study.
16.2.1 Devices Not Approved by the FDA (including "510(k) devices"): BEU
16.2.2 * What is the generic name or descriptor of the device? Include trade names if
available.
16.2.2.1 * Has this device been designated as a "510(k) device"?
16.2.3 * What is the source of the device? Include both supplier and manufacturer if
different.
16.2.4 * What is the proposed mechanism of action of the device? Include any post- BEU
manufacturing modifications to the device.
16.2.5 * What is the frequency and total duration of use of the device for an individual
subject?
16.2.6 * What is sponsor‘s risk designation for the device according to FDA definitions?
16.2.7 Non-significant Risk Device Detail: Complete the following two questions for devices
that have a non-significant risk designation
16.2.7.1 Describe why this device and its use, as proposed in this study, constitute a non-
significant risk to the subjects involved. Include an evaluation of the safety risks to the
subject in the event of a device failure.
16.2.7.2 Upload documentation from the sponsor that supports the determination that the
device does not pose a significant risk to subjects. Include documentation of any prior
investigations or other supporting materials.
16.2.8 Significant Risk Device Detail: Complete the rest of this section for devices that have
a significant risk designation.
16.2.8.1 What is the IDE number? BEU
IDE Filing Date
16.2.8.2 Who holds the IDE? BEU
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16.2.8.3 FDA IDE Documentation: For an investigator-sponsored IDE (an IDE submitted to BEU
the FDA by a University investigator) submit copy of the IDE application and subsequent
FDA correspondence, including any amendments. For a manufacturer-sponsored IDE,
submit copies of the investigator‘s brochure or similar document.
16.2.8.4 What is the FDA Device Center for Medicare and Medicaid Services (CMS)
Reimbursement Category?
16.2.8.5 Will subjects, or their insurance providers, be charged for the device?
16.2.8.5.1 If yes, explain how the charge does not exceed the cost necessary to recover
costs of manufacture, research, development, and handling of the investigational device.
16.2.9 FDA Approved Devices used for a non-approved indication (i.e. dosage, route of
administration, or population):
16.2.10 * What is the generic name or descriptor of the device? Include trade names if BEU
available.
16.2.11 * What is the source of the device? Include both supplier and manufacturer if
different.
16.2.12 * What is the proposed mechanism of action of the device? Include any post- BEU
manufacturing modifications to the device.
16.2.13 * What is the frequency and total duration of use of the device for an individual
subject?
16.2.14 * Briefly describe how the research use departs from the FDA approved indication.
16.2.15 * Describe the purpose of the ―off-label‖ evaluation. (e.g. to support a new indication
for the use of the device, to support any other significant change in the labeling or
advertising for the device, etc.)
16.2.16 * What is sponsor‘s risk designation for the device?
16.2.17 Non-significant Risk Device Detail: Complete the following two questions for devices
that have a non-significant risk designation
16.2.17.1 Describe why this device and its use, as proposed in this study, constitute a non-
significant risk to the subjects involved. Include an evaluation of the safety risks to the
subject in the event of a device failure.
16.2.17.2 Upload documentation from the sponsor that supports the determination that the
device does not pose a significant risk to subjects. Include documentation of any prior
investigations or other supporting materials.
16.2.18 Significant Risk Device Detail: Complete the rest of this section for devices that
have a significant risk designation.
16.2.18.1 What is the IDE number? IDE Filing Date: BEU
16.2.18.2 Who holds the IDE? BEU
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16.2.18.3 FDA IDE Documentation: For an investigator-sponsored IDE (an IDE submitted to BEU
the FDA by a University investigator) submit copy of the IDE application and subsequent
FDA correspondence, including any amendments. For a manufacturer-sponsored IDE,
submit copies of the investigator‘s brochure or similar document.
16.2.18.4 What is the FDA Device Center for Medicare and Medicaid Services (CMS)
Reimbursement Category?
16.2.18.5 Will subjects, or their insurance providers, be charged for the device?
16.2.18.5.1 If yes, explain how the charge does not exceed the cost necessary to recover
costs of manufacture, research, development, and handling of the investigational device.
16.2.19 FDA Approved Devices:
16.2.20 * What is the generic name or descriptor of the device? Include trade names if BEU
available.
16.2.21 * What is the source of the device? Include both supplier and manufacturer if
different.
16.2.22 * What is the proposed mechanism of action of the device? Include any post- BEU
manufacturing modifications to the device.
16.2.23 * What is the frequency and total duration of use of the device for an individual
subject?
16.2.24 Upload any supporting documentation here:
17. Placebo Required if yes to 7-1.8
17.1 * Briefly describe the placebo (drug, device, procedure, intervention, surgery, etc.)
control arm used in the study.
17.2 * Provide a justification for use of the placebo, including the length of subject
participation in the placebo arm.
17.3 * Describe any commonly used diagnostic/treatment approach(es) that will be withheld
from subjects assigned to the placebo arm of this study.
17.4 * Is study enrollment limited to individuals for whom the commonly used
diagnostic/treatment approaches are known to be ineffective or intolerable?
17.5 * Summarize the risk to subjects in the placebo arm who receive no active treatment for
their disease or condition.
17.6 * How will the condition or disease of subjects in the placebo arm of this study be
monitored, compared to the monitoring associated with standard care for this
disease/condition?
17.7 * What criteria will be used to determine that the participation of a subject, who may be
receiving a placebo treatment, should be discontinued due to his/her worsening disease or
condition?
18. Biological Specimens Required if yes to 7.1
18.1 * List all of the human biological specimens that will be used in the study.
18.1.1 Blood obtained directly from subjects for the purpose of this research
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18.1.2 * By what route and method will the blood be collected?
18.1.3 * Describe the blood collection schedule. Indicate the total amount to be collected
from each subject and show how this amount was calculated from the frequency, volume per
collection, and duration of participation in the study. Indicate the volume in milliliters and, in
the case of children, also as a percentage of total blood volume. (If covered in attached
protocol, indicate section.)
18.1.4 Non-blood specimens obtained directly from subjects for the purpose of this research
study (NOT from specimens removed for medically indicated reasons)
18.1.5 * What kinds of biological specimens will be used? TPS
18.1.6 * By what method will the biological specimens be collected? TPS
18.1.7 * Who will collect the biological specimens from the subjects? Specify source name TPS TPS
and primary contact (e.g., directly from physician, UMHS clinical pathology labs, UMHS
delivery rooms, remote institutions, etc.)
18.1.8 * Describe the specimen collection schedule, including frequency, duration (first to TPS
last collection), and amount (size, weight, or volume). Indicate the total amount to be
collected from each subject and show how this amount was calculated from the frequency,
duration, and amount per collection as indicated.
18.1.9 Blood or non-blood residual or to-be-discarded specimens
18.1.10 * What kinds of biological specimens will be used (e.g., surplus tissue collected for TPS
medical reasons, placenta, placental cord blood, etc.)?
18.1.11 * From what entity or repository will the biological specimen be obtained? TPS TPS
MADRC
Tissue Procurement Service
MADRC Neuropathology Core
Pathology Department Paraffin Archive
Other
If "Pathology Department Paraffin Archive", describe the study team's arrangement to use
the archive for the purposes of this research.
If other, specify source name and primary contact (e.g., directly from physician, UMHS
clinical pathology labs, UMHS delivery rooms, American Red Cross, remote institutions,
etc.)
18.1.12 * Under what circumstances will the biological specimens be collected? TPS
18.1.13 * Describe the arrangements to ensure that residual or to-be-discarded biological TPS
specimens are obtained ONLY after a sufficient sample has been secured to fulfill the non-
research objective for collection.
18.1.14 * What is the MINIMUM amount of tissue/fluid required per specimen (approximate TPS
size, weight, or volume)?
18.1.15 Blood or non-blood existing, banked, human biological specimens
18.1.16 * Describe the type of biological specimens to be studied, including any potential
subject identifiers on the label.
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18.1.17 * Name the banks or repositories from which the biological specimens will be
obtained.
If "Pathology Department Paraffin Archive", describe the study team's arrangement to use
the archive for the purposes of this research.
If other, specify bank/repository and include contact name:
18.1.18 * What was the original purpose for the collection of these biological specimens?
18.1.18.1 If collected in conjunction with a different study, provide the IRB approval
documentation including the informed consent document.
18.1.18.2 If collected for non-research purposes, describe the original informed consent
process (e.g., institutional consent previously signed by persons at the time of a surgical
procedure within the University of Michigan Health System or Dental School).
18.1.19 * What is the MINIMUM amount of tissue/fluid required per specimen (approximate
size, weight, or volume)?
18.2 * Is there a link between the biological specimens and the identity of the person from
whom the material originated?
18.2.1 If yes, what action(s), if any, will be taken in the event that the research reveals
information of potential benefit to the subject or identifies a clinically significant, unexpected
disease or condition?
18-1 Tissue Procurement Core Detail Required if TPS selected in 18.1.8 or 18.1.12
18-1.1 * Is the PI a member of the Comprehensive Cancer Center? TPS
18-1.2 * Contact person for collection, include phone/pager: TPS
18-1.3 Tissue Requirements: TPS
18-1.3.1 * Organ(s) or Site(s): TPS
18-1.3.2 * Type of tissue (e.g.,neoplastic, normal, both, etc.): TPS
18-1.3.3 * Any special patient characteristics (e.g., age, sex, etc.) or limiting characteristics: TPS
18-1.3.4 * Mode of procurement and collection (e.g., frozen in tube, frozen in OCT, fresh in TPS
tube, fresh in media, etc.): Be as specific as possible. Note: Confirmation with the Tissue
Procurement Core technologist after approval for services is issued is required.
18-1.3.5 * Total number of specimens desired:
18-1.3.6 * Desired time period of collection:
18-2. MADRC Neuropathology Core Detail Required if MADRC selected in 18.1.12
18-2.1 * What diseases are you going to study?
18-2.2 * How many neuropathology core samples will you need to complete your study?
18-2.3 * What area(s) of the brain will you want for study?
18-2.4 Specific needs not previously identified:
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18-2.5 * Affirm that the PI has received a copy of the Policy for Michigan Alzheimer's
Disease Research Center (MADRC) Core Support and agree to abide by the conditions
stated therein (link to PDF of policy):
19. Human Embryonic Stem/Germ Cell Research Required if answered yes to 7-1.9
19.1 * Michigan Statute (MCLA 333.26274 and 750.430a) prohibits "human cloning.‖
"Human cloning" means the use of human somatic cell nuclear transfer technology to
produce a human embryo. "Human embryo" means a human egg cell with a full genetic
composition capable of differentiating and maturing into a complete human being. "Human
somatic cell" means a cell of a developing or fully developed human being that is not and will
not become a sperm or egg cell. "Human somatic cell transfer" means transferring the
nucleus of a human somatic cell into an egg cell from which the nucleus has been removed
or rendered inert.
Check to affirm that this study does not involve ―human cloning.‖
19.2 * This cell line study involves the following methodologies:
19.3 List any cell lines to be used in this study that are listed on the NIH Human Embryonic
Stem Cell Registry. Research on existing human embryonic stem cell lines may be
conducted with federal support if the cell lines meet the U.S. Presidential criteria, announced
on August 9, 2001 (See Notice Of Criteria For Federal Funding Of Research On Existing
Human Embryonic Stem Cells And Establishment Of NIH Human Embryonic Stem Cell
Registry).
19.4 List any cell lines to be used in this research that are NOT listed on the NIH Human
Embryonic Stem Cell Registry. There are numerous issues involved with the use of cell lines
not listed on the NIH registry that will require significant IRB and institutional consideration.
Contact the IRB Office at the earliest opportunity for guidance prior to submitting this
application.
20. Genetic Analysis Required if answered yes to 7.2
20.1 * Indicate on which biological specimens the genetic analysis will be performed.
20.2 * What is the specific purpose of the genetic analysis?
20.3 * What particular genetic information will be acquired?
20.4 * Will any genetic information or specimens be shared with colleagues outside the
study?
If yes, answer the following two questions.
20.4.1 Is this intention disclosed in the informed consent?
20.4.2 How will the privacy of the subject be protected in the transfer? Indicate whether
identifiable information will be included in the transfer.
20.5 * Are the special risks associated with genetic analysis disclosed in the informed
consent document (e.g., psychological, emotional, loss of insurability, loss of employability,
discovery of previously unknown health conditions, discovery of paternity, or discovery of
carrier status, etc.)?
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20.6 * Will the subject be given the opportunity to specifically indicate in the informed
consent document (e.g. via checkbox) his/her desire to receive these results?
20.7 * Will the results of the genetic testing be shared with the research subject?
20.7.1 Justify why the results will or will not be shared with the research subject.
20.7.2 Will the testing be performed in clinical diagnostic laboratories?
20.7.3 Will genetic counseling be available to subjects to explain the findings?
20.7.3.1 If yes, will the cost of providing the counseling be covered by the study?
20.7.3.1.1 If no, justify why the study has not made provisions to pay these costs.
21. Ionizing Radiation Required if answered yes to 7-2.2
21.1 * Will subjects be exposed to any ionizing radiation from EXTERNAL sources SOLELY
for the purposes of this research study? External ionizing radiation includes x-rays, beta-
rays, gamma-rays, neutrons, and other high-speed atomic particles.
If yes, answer the following three questions. If no, jump to 21.2.
21.1.1 List type of procedure(s) and the location(s) where they are performed. (Include the
building and room number)
21.1.2 What is the purpose of procedure(s) (e.g., diagnostic, therapeutic, research, etc.)?
21.1.3 Describe the fields of exposure, target organs, frequency and total duration of use.
21.2 * Will subjects be exposed to any ionizing radiation from INTERNAL sources SOLELY RPC Require Secion
for the purposes of this research study? [Require sections 21-1, 21-2, and 21-3] 21-1-3
21.3 * List any additional ionizing radiation that subjects will be exposed to for healthcare
reasons (standard of care) while participating in this study:
21.4 * Estimate the amount of radiation exposure from each procedure to be administered
during the course of this study for both research and healthcare reasons. For each
procedure listed in 21.1, 21.2 and 21.3, please provide dosimetric information (include the
source, i.e., published literature or other valid studies), as measured in terms of Roentgen
equivalents in man (rem).
21.5 * What precautions will be taken to protect others from unintended exposure to the
radiation (i.e., members of the public, hospital staff, family members, etc.)?
21-1. RDRC/SHUR Information Required if answered yes to 21.2
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21-1.1 The list below includes all study team members identified in section 1.3 of this RDRC
application. In addition to the information provided in section 1.3, the RDRC/SHUR SHUR
committee also requires the following:
The study must have at least one Nuclear Regulatory Commission (NRC)-defined
Authorized User Physician and one University of Michigan approved Authorized User with
RSS-101 or RSS-102R authorization to order radioisotopes or radiochemicals involved in
this study.
The Authorized User Physician and Authorized User with RSS-101 or RSS-102R
authorization will need to complete an additional activity in eResearch to accept this role
prior to submission of the application.
A summary of each study team member's training and experience in the use of
radioisotopes (e.g., human, animal, in vivo, in vitro, laboratory work, etc.).
Click the study team member name to identify the NRC-defined Authorized User Physician,
UM-approved Authorized User with RSS-101 or RSS-102R authorization, or summarize the
radioisotope training and experience for that study team member. You may add new study
team members, if necessary. Please note that additions/deletions in this section will also
update section 1.3 of this application. radioisotope experience and training.
21-1.1.1 * Describe this team member's RDRC
SHUR
21-1.1.2 * Is this study team member an authorized user physician, dentist, or podiatrist RDRC
responsible for radioisotope administration to humans? SHUR
21-1.1.3 * Is this study team member an authorized user who has an RSS-101 authorization RDRC
to order radioisotope(s) or radiochemicals involved in this study? SHUR
21-1.1.3.1 If yes, indicate the RSS-101 approval number. RDRC
SHUR
21-1.2 * Indicate the location(s) of use for the radioisotope work (building and room RDRC
number). SHUR
21-1.3 * This request is for: RDRC RDRC
SHUR SHUR
21-1.3.1 If study is under 21-1.3(c) RDRC approval, affirm that the active ingredients or RDRC
combination of active ingredients to be administered will not cause any clinically detectable SHUR
pharmacological effects in the subjects.
21-1.3.2 Approval of studies under 21-1.3(a) and/or 21-1.3(b) requires the submission of RDRC
annual reports. Approval of studies under 21-1.3(c) requires the submission of quarterly and SHUR
annual reports. (The PI must submit an ORIO in the eResearch system when filing any of
these reports. The report is attached to the ORIO, which records the report's submission
and routes the report to the RDRC/SHUR committee.
Failure to submit these reports in a timely manner will result in the suspension of this
approval. Click here for more information on downloading the forms.
Confirm that you will submit the reports on time.
21-2. RDRC/SHUR Information Required if answered yes to 21.2
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21-2.1 * Number of patients: RDRC
SHUR
21-2.1.1 * Check age range of patients to whom radioisotopes will be administered under RDRC
this study SHUR
21-2.2 * Number of normal subjects: RDRC
SHUR
21-2.2.1 * Check age range of normal subjects to whom radioisotopes will be administered RDRC
under this study SHUR
21-2.3 * Affirm that if women are involved in this research, the study team will perform a RDRC
pregnancy test 72-hours before administering the dose, except for those women who meet SHUR
the following criteria:
pre-menarche women,
post menopausal women, or
tubal ligation.
21-2.4 * Affirm that preclinical toxicology studies have demonstrated no evidence of toxic RDRC
effects as a result of the drug administered to experimental animals. SHUR
21-2.4.1 * Indicate the source of these studies (i.e., literature, in-house studies,
manufacturer).
21-2.5 * Explain all procedures. Provide in a point-by-point, concise, bulleted format. (A RDRC
summary must be inserted here. A more detailed protocol may be attached to the SHUR
application, but does not substitute for this summary.)
21-3. RDRC/SHUR Information Required if answered yes to 21.2
21-3.1 * Add detail about each radiopharmaceutical to be received by subjects: RDRC
SHUR
21-3.1.1 * Radiopharmaceutical Name RDRC
SHUR
21-3.1.2 * Has an Investigational New Drug (IND) application been filed for this RDRC
radiopharmaceutical? SHUR
If yes, provide answers to the following: RDRC
21-3.1.2.1 Indicate the IND number: SHUR
21-3.1.2.2 Indicate the Institution:
21-3.1.3 * Indicate the Active Ingredient and Quantity (milligrams) to be administered. RDRC
SHUR
21-3.1.4* Indicate the total activity of each radioisotope per administration. RDRC
SHUR
21-3.1.5* Indicate the total activity of each radioisotope to be administered over the course RDRC
of the research study. SHUR
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21-3.1.6* What, if any, toxic or pharmacological effects may occur? (NOTE: If study is being RDRC
performed under 21-1.3(c), evidence must be presented that there will be no SHUR
pharmacological effect in human subjects. Include literature reference(s) for
pharmacological dose data.)
21-3.1.7* Attach pharmacological dose calculations based on data available from published RDRC
literature or from other valid human studies. SHUR
21-3.1.8* Route of Administration (injection, IV, oral, etc): RDRC
SHUR
Submit data for other absorbed radiation doses that result from this experimental protocol RDRC
[fluoroscopic or radiographic x-rays, transmission scans, cat scans (CT), bone densitometer SHUR
(Dexa Scan), etc). (Exclude absorbed radiation doses resulting from clinically indicated
procedures. In selecting experimental subjects, investigators should consider all previous
exposures.)
21-3.1.9.1* Fluoroscopic or radiographic dose (mrem): RDRC
SHUR
21-3.1.9.2* Transmission scan dose or cat scan (CT) dose (mrem): RDRC
SHUR
21-3.1.9.3* Bone densitometer (Dexa Scan) dose (mrem): RDRC
SHUR
21-3.1.9.4 Other: RDRC
SHUR
21-3.1.9.5* Indicate the total number of doses to be administered to the same patient: RDRC
SHUR
21-3.1.9.6* The doses listed for this radioisotope will be administered over a period of ___ RDRC
weeks. SHUR
21-3.1.10* Add the Detail File (DF) for this radiopharmaceutical: RDRC
SHUR
21-3.1.10.1 Upload any additional supporting documentation here. RDRC
SHUR
21-3.1.11* Add the Master Formula Card (MFC) for this radiopharmaceutical. RDRC
SHUR
21-3.2 Affirm that the PI will adhere to the FDA's labeling requirements specified in FDA RDRC
regulations 21 CFR 361.1(c)(8). SHUR
21-3.3 Add the dosimetry table for each radiopharmaceutical to be received by subjects: RDRC
SHUR
22. Organ/Tissue/Cell Transfer Required if yes to 7-2.3
22.1 * What organs, tissues, or cells from other humans (including fetal tissue) or animals
will be administered to subjects for the purposes of this study?
22.2 * How and from whom will the organs, tissues, or cells be procured for subsequent
administration to subjects?
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22.3 * What measures will be taken to prevent transfer of undesirable elements from human
or animal donors? (Specifically for human immunodeficiency virus (HIV), confirm that each
human donor of such materials or the materials themselves will be tested and that no
material from positive donors or no positive material will be used. Please note: Michigan law
requires a subject‘s prior written consent to non-anonymous HIV testing).
22.4 * What action, if any, will be taken in the event that clinically significant information is
discovered about the donor of the transplant organ, tissue, or cell?
22.5 * If women with reproductive potential are involved, describe the measures that will be
taken to avoid harm to a potential fetus or offspring.
22.6 * Does this research involve human fetal tissue transplantation? There are numerous
issues involved with the conduct of this type of research that will require significant IRB and
institutional consideration. Contact the IRB Office at the earliest opportunity for guidance
prior to submitting this application.
23. Gene Transfer to Humans Required if yes to 7-2.4.
23.1 * Has this proposal already been submitted to and reviewed by the NIH Office of IBC
Biotechnology Activities (NIH OBA)?
23.1.1 If yes, please provide the assigned RAC number. (The IBC will also require a copy of IBC
the outcome letter from NIH OBA.)
23.1.2 If no, please provide the (anticipated) submission date. IBC
23.2 If the gene transfer work in this proposal is similar or related to other work you or IBC
colleagues have performed at the UM, please give the name of the PI, project title, and date.
In some instances this information may help to expedite the review process.
23.3 * What is the therapeutic gene? Give details of the rDNA construct, including the nature IBC
of the gene (e.g., genomic, cDNA, synthetic, etc.), control elements (e.g., enhancers,
promoters, splice and poly(A) sites, etc.), and the vector backbone.
23.4 * Specify which vectors will be used. IBC
23.5 * Will helper virus be used? IBC
23.5.1 If yes, please specify. IBC
23-1. Gene Transfer to Humans Required if yes to 7-2.4.
23-1.1 * What measures will be taken to minimize the risk of subsequent development of IBC
acute or persistent pathogenic viral infection, or mutagenesis?
23-1.2 * What is the likelihood of dissemination of the virus vector to others? IBC
23-1.3 * What is the target tissue, organ and/or cell? IBC
23-1.4 * The addition of the genes to the target cells will be done IBC
If In vitro, answer the following two questions. IBC
23-1.4.1 What method will be used to obtain tissues or cells from the subject? IBC
23-1.4.2 What safety precautions will be taken in processing the cells? IBC
23-1.5 * What measures will be taken to preclude insertion of the genetic material into germ IBC
cells of the subject? (At present, gene transfer is permissible only to somatic cells.)
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23-1.6 * What will be the expressed product of the gene? IBC
23-1.6.1 * Will the product be secreted from the host or from the cell? (Note: This question is IBC
not asking - will the product be EXCRETED)
23-1.7 * What kinds of preclinical studies in suitable cell and animal models were done to IBC
show efficacy and safety of the gene transfer protocol to be employed in the proposed
project, and what were the outcomes?
23-1.8 * What may be the significant adverse effects of this study upon the subjects? IBC
23-1.9 * If subjects with reproductive potential are involved, what contraceptive measures IBC
will be taken for both females and males during the active phase of the study?
23-1.10 * Will the subjects be outpatients? IBC
23-1.11 * What measures will be taken to secure long-term follow-up of the subject, and IBC
autopsy in case of death?
23-2. Gene Transfer to Humans Required if yes to 7-2.4.
23-2.1 * Please list the locations where work on this protocol will take place. Include the IBC
room numbers and buildings where possible.
23-2.2 * Will this work involve use of the Human Applications Laboratory (HAL)? IBC
23-2.2.1 If yes, please describe the services to be provided by the Human Applications IBC
Laboratory.
23-2.3 * At what level of containment do you propose to carry out production of the human IBC
gene transfer product?
23-2.3.1 * Will a biosafety cabinet be used for any part of the work? IBC
23-2.3.1.1 If yes, please provide the lab location for the biosafety cabinet and describe the IBC
work to performed there.
23-2.3.1.2 If no, please provide justification for not using a biosafety cabinet. IBC
23-2.3.2 * Describe the specific precautions to be taken by the research staff in IBC
producing/handling the gene transfer product (prior to administration to patient).
23-2.4 * At what level of containment/precaution do you propose clinical research staff IBC
administer the human gene transfer product to patients?
23-2.4.1 * Describe the specific precautions to be taken by the research staff in IBC
administering the gene transfer product.
23-2.5 * Is there a Materials Transfer Agreement associated with this work? IBC
If yes, answer the following two questions. IBC
23-2.5.1 What item will be transferred and who/what institution is the source? IBC
23-2.5.2 What is the Materials Transfer Number? IBC
23-2.6 * Does this proposal involve any use of Select Agents? For a list of Select Agents, IBC
see Help.
23-2.6.1 If yes, please specify IBC
23-2.7 * Upload an electronic copy of Appendix M. IBC
23-2.8 * Upload an electronic copy of the scientific abstract. IBC
24. Secondary Data Analysis Required if yes to 7.3
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24.1 * List each pre-existing data set that will be used in the study.
24.2 * Name and source/location of data set:
24.3 * Describe the type of information contained in the data set, including any potential
subject identifiers.
24.4 * Is the data set you are analyzing publicly available?
If yes, scroll to the bottom of this page and click OK. If no, answer the rest of the questions.
24.5What was the original purpose for the collection of data in this set?
24.5.1 If collected in conjunction with a different study, provide the IRB approval
documentation.
24.6 Was prior consent from the subjects obtained to utilize the data set for this study (or
for unspecified future research)?
24.6.1 If yes, describe the terms of the consent as they relate to this study or unspecified
future research, include relevant excerpts from the consent.
If available, upload the prior consent documents here.
24.6.2 If no, indicate intention to obtain a waiver of informed consent (and, if applicable,
HIPAA authorization) or describe the plan to re-establish the identifying links and re-consent
individuals.
25.HIPAA U-M Covered Components Required if yes to 7.4
25.1 * Select all University of Michigan HIPAA-covered component schools, departments, Require
division or other units for which either of the following is true about this study: remainder of
One or more study team members is a regular employee (faculty or staff), contractor, section 25 below
student, or trainee assigned to the school, department, division, or other unti (whether full- unless "None of
time, partial, or dry appointment); OR the above" is
The school, department, division, or other unit discloses any information about individual checked.
subjects to any member of the study team, or, permits study team members to access
information. This includes information that has been or will be de-identified.
Select all that apply:
University of Michigan Health System (including hospitals and health centers, medical
school, M-CARE, MVN, MHC, joint ventures)
School of Dentistry
School of Nursing Nurse-Managed Centers
UM-Flint Urban Health and Wellness Center
University Health Service
Institute for Human Adjustment
UM Autism and Communication Disorders Center
UM Employee Benefits (only those units that manage UM health benefit plans, including
medical, dental, vision, and healthcare FSAs)
None of the above
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25-1.Protected Health Information (PHI) / HIPAA Required in any component other than "None of the above" selected in 25.1
25-1.1 * Identify the PHI to be used. Select all that apply:
Hospital/doctor's office records, including test results and dental records
Mental health care records (except psychotherapy notes not kept with medical records)
Psychotherapy notes (e.g., process notes) maintained separately from the regular medical
record
Alcohol/substance abuse treatment records
AIDS/HIV, STD, or other serious communicable disease records (including testing,
diagnosis, treatment, and outcomes records)
Genetic counseling/genetic testing records
Health plan/health insurance records
Any records relating to condition, the treatment received, and response to the treatment
Billing information
Demographic information
Personal identifiers
Other
25-1.2 * Explain why the PHI listed above is the minimum necessary to conduct the study
(i.e., explain why the study could not reasonably and effectively be conducted without the
PHI).
25-1.3 * Will HIPAA authorization for access to the PHI be obtained for all or some subjects?
Select one:
HIPAA authorization was/will be obtained from all subjects
HIPAA authorization will not be obtained from some subjects or from some candidates for
recruitment before their records are reviewed for eligibility determination or to obtain contact
information
HIPAA authorization will not be obtained from any subjects
25-1.3.1 If HIPAA authorization for access to the PHI will be obtained from some or all
subjects before their data is collected, used or disclosed (including for eligibility
determination or recruitment), indicate the document/process to be used: Select one:
Integrated with informed consent document/process (All IRBMED apps must select this)
Separate from the informed consent document
Medical record release from other institutions
Other - If other, please specify:
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25-1.3.2 If HIPAA authorization for access to the PHI will NOT be obtained from some or all
subjects/candidates for recruitment, indicate what alternative(s) will be used:
Select all that apply:
Request for full or partial waiver of HIPAA authorization
Review of data preparatory to research. Note: this exception is not necessary if a full or
partial waiver of authorization is granted.
Limited data set(s)
Deidentified data sets (data will be completely deidentified before use for research
purposes).
25-2. HIPAA Authorization Waiver Request Completion of this section is required based on the response provided to question 25-1.3.2.
25-2.1. * Waiver of HIPAA authorization requested for:
Select all that apply:
Entire project
Survey portion only
Recruitment portion only
Specific subject group only
Other portion or aspect of the project
If other, please specify:
25-2.2 * To ensure that this research use of the PHI involves no greater than minimal risk to
privacy, describe the plan to protect patient-subject identifiers from improper use or
disclosure.
25-2.3 * To ensure that this research use of PHI involves no greater than minimal risk to
privacy, describe the plan to destroy patient-subject identifiers at the earliest opportunity
consistent with the research. Indicate at what point in the research the patient-subject
identifiers will be destroyed. If applicable, provide a health, research or legal justification for
retaining the identifiers.
25-2.4 * To ensure that this research use of the PHI involves no greater than minimal risk to
privacy, provide assurance that this information will not be reused or disclosed to any other
person or entity (i.e., outside the research study team), except as required by law, for
authorized oversight of the research study, or for other research for which the IRB has
granted a waiver of the HIPAA authorization.
25-2.5 * Why could this research not practicably be conducted unless the waiver of HIPAA
authorization is granted [45 CFR 164.512 (i)(2)(ii)(B)]?
25-2.6 * Why could this research not practicably be conducted without access to and use of
the PHI [45 CFR 164.512(i)(2)(ii)(C)]?
25-2.7 * Will data containing PHI be shared outside of the U-M covered component? Send notice Privacy
to Privacy Office
Board if yes
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25-2.7.1 If yes, affirm that disclosures of PHI outside the U-M covered component will be
tracked and reported according to guidelines published by the U-M HIPAA privacy office.
25-3. Certification for Review of Data Preparatory Required if Limited Data Set selected in 25-1.3.2
to Research
25-3.1 * Affirm that the PHI will be used only for one or more of the following purposes: Privacy
To determine whether the proposed project is feasible, or to assist in the design of the Office
project. In either case, the study team will not record any PHI reviewed for this purpose into
a dataset that may later be used for the project itself.
To ask potential subjects whether they want to consider participating in the study. In this
case, the study team will record only name and contact information and will not use this
information for any other activity.
25-3.2 * Confirm that no PHI will be removed from the U-M covered component during this Privacy
review preparatory to research. This information may not be sent off-site to anyone, even a Office
sponsor or consultant or vendor helping with or monitoring the study. Note: individuals
outside the U-M covered component, including sponsors, consultants, and monitors, may
review the information on-site.
25-3.3 Will individuals outside the U-M covered component review the information on-site? Send notice Privacy
to Privacy Office
Board if yes
25-3.3.1 If yes, affirm that disclosures of PHI outside the U-M covered component will be Privacy
tracked and reported according to guidelines published by the U-M HIPAA privacy office. Office
25-4. Limited Data Set Completion of this section is required based on the response provided to question
25-1.3.2.
25-4.1 * Affirm that the limited data set will NOT include ANY of the following information Privacy
about subjects, or their relatives, employers or household members. Office
Affirm all:
Names
Postal address information other than city, town, state, or zip code
Telephone, fax numbers, e-mail addresses, web URL addresses, IP addresses
Social security number, medical record number, health plan beneficiary number, any
account number, certificate, or license number
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Biometric identifiers (e.g., fingerprints, voice prints) -- DNA is not considered a biometric
identifier for HIPAA purposes
Full-face photographs and any comparable images
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25-4.2 * Affirm that only the Authorized Parties will access, use or disclose information in the Privacy
limited data set (―LDS‖), and that they will comply with all of the conditions listed below: Office
The LDS will be used or disclosed only for the research project described in this application.
The LDS will be used or disclosed consistent with the IRB-approved protocol or as required
by law.
Appropriate safeguards will be used to prevent use or disclosure of LDS information other
than as provided for by this application and the IRB approval.
Any use or disclosure not permitted under the IRB-approved protocol will be promptly
reported to the HIPAA Privacy Office.
No attempt will be made to re-identify or contact individuals whose information is included in
the LDS.
Note: violations may result in discontinued access to the data, a report to the Secretary of
the Department of Health and Human Services, and other sanctions.
25-4.3 Will the limited data set be shared outside the U-M covered component? Send notice Privacy
to Privacy Office
Board if yes
25-4.3.1 If yes, affirm that a Data Use Agreement will be obtained prior to its release. Note: if Privacy
a DUA has not been signed at the time of the application, a signed copy must be forwarded Office
to the HIPAA Privacy office at 7319 Medical Science I, 1301 Catherine Street, Ann Arbor, MI
48109-0626 before disclosing the limited data set.
25-4.3.1 If yes, affirm that a Data Use Agreement will be obtained prior to its release. Note: if Privacy
a DUA has not been signed at the time of the application, a signed copy must be forwarded Office
to the HIPAA Privacy office at 7319 Medical Science I, 1301 Catherine Street, Ann Arbor, MI
48109-0626 before disclosing the limited data set. Upload the Data Use Agreement here.
The Data Use Agreement form for UMHS (IRBMED) is available for download from the
UMHS Privacy Board website.
25-5 Deidentified Data Set Completion of this section is required based on the response provided to question
25-1.3.2.
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Affirm that the deidentified data set will NOT include ANY of the following information about
subjects, or their relatives, employers or household members:
Names
Address, city, and other geographic information smaller than state (3-digit zip code is
acceptable if it includes more than 20,000 people; otherwise, use ―000‖)
Telephone, fax numbers, e-mail addresses, web URL addresses, IP addresses
Social security number, medical record number, health plan beneficiary number, any
account number, certificate, or license number
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Biometric identifiers (e.g., fingerprints, voice prints) DNA is not considered a biometric
identifier for HIPAA purposes of HIPAA
Full-face photographs and any comparable images
Any other unique identifying number, characteristic, or code
26. Epidemiology Required if yes to 7.5
26.1 * Would this study be conducted if the results could not be published in a peer-review
journal?
26.2 * Explain how any culturally sensitive issues pertaining to this study population will be
addressed (e.g. informed consent process, confidentiality, data collection, etc.).
26.3 * Will information useful to the study population be generated during this study?
26.3.1 If yes, will it be communicated to the population?
26.3.1.1 If yes, explain the plan and process. If no, explain why not.
27. Deception Research Required if yes to 7-1.3
27.1 * Indicate why deception is the only feasible means of conducting this research. Include
information about the likely characteristics and cultural values of the subjects that contribute
to the justification for using deception.
27.2 * Provide a detailed explanation of the nature of the deception including the use of any
"confederates."
27.3 * Is this research likely to produce psychological discomfort or negative feelings in the
subjects?
If yes, answer the following two questions. If no, jump to 27.4.
27.3.1 If yes, describe the arrangements made to provide professional counseling or support
resources to any subjects desiring such assistance following their participation in the study.
27.3.2 Indicate how the list of counseling or support resources will be provided:
27.4 * If you are obtaining informed consent from the subjects, is the informed consent
document or process a part of the deception?
27.4.1 If yes, please explain the specific elements of deception that are incorporated into the
informed consent document or process:
27.5 * Do you plan to debrief subjects at the conclusion of the study?
27.5.1 If yes, upload the debriefing document here.
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27.5.2 If no, justify why the deception will not be explained to subjects at the conclusion of
the study.
28. Internet/Email Required based on the response provided to question 7.1-4
28.1 * Please explain the specific information technology resources that will be utilized (e.g.,
web pages, specific email system).
28.2 * Please explain the electronic security measures that will be employed to protect the
privacy of the research subjects and the integrity of the information (e.g., firewalls,
encryption, dedicated servers, password access, intrusion or hacking protection).
28.3 * Will representatives or advocates of the "community" under study be consulted in
order to understand their expectations of privacy on the Internet or via email?
28.3.1 * Explain.
28.4 * If the results will be published or presented, will the pseudonyms/screen names of
individuals studied be disguised? Answer N/A if the study will not be published or presented.
28.4.1 * Explain.
29. Survey Research Required based on the response provided to question 7-1.5
29.1 * Provide a list of all surveys and interviews used in the study:
29.2 * Survey or interview name:
29.3 * Is the design or development of this survey instrument dependent on receipt of
funding or hiring of personnel?
29.4 In what manner will the survey or interview be conducted (e.g., in-person, Internet,
mail, telephone, etc.)? Special Note: For electronic surveys, the eResearch ID number must
be included in the informed consent document (uploaded in section 10-1) or other material
that serves as the informed consent.
29.5 What is the predicted response rate?
29.6 What is the total number of questions?
29.7 What is the anticipated cumulative amount of time required for each subject?
29.8 What is the total number of interviews/data collection interactions with an individual
subject?
29.9 Does the survey or interview contain questions of a sensitive nature (e.g., mental
illness, sexual abuse, illicit drug use, etc.)?
29.10 Is the survey or interview likely to produce psychological discomfort or negative
feelings in the subjects?
29.11 Has the survey instrument been validated or used in standard practice?
29.11.1 If yes, describe the origin of the instrument.
29.12 Upload the survey instrument here.
29.13 * Will the research involve the use of focus groups?
29.13.1 If yes, how will the identity of individuals participating in the groups be protected?
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If any material is likely to be disturbing, please answer the following:
29.14 Describe the arrangements made to provide professional counseling or support
resources to any subjects desiring such assistance as a result of their participation in the
study.
29.15 Indicate how the list of counseling or support resources will be provided:
Select one:
Informed consent document
Debriefing document
Separate resource list
Other
No resource list will be provided
Clear
If other, please specify:
30. International Completion of this section is required based on the response provided to question 7.6
30.1 * Will the principal investigator be traveling to another country to conduct the research?
30.1.1 If yes, will the PI be able to communicate with the IRB from the site?
30.1.1.1 If no, who will act as the representative in matters of communicating with the IRB to
report any adverse events or other information related to protocol modifications or
renewals?
30.2 * Which research procedures will be performed at the foreign site(s)?
30.3 * Describe any special arrangements to protect subject confidentiality at the foreign
site(s).
30.4 * Describe the study team‘s knowledge of the local culture and community.
30.5 * Describe any additional local or customary permissions required in order to contact
subjects and/or conduct this research (e.g. tribal counsel)?
31. Watching/Listening to Audiovisual Materials Completion of this section is required based on the response provided to question 7-1.6
31.1 * Provide a list of all audiovisual materials used in the research (e.g., audio and video
recordings, photographs, pictures, etc.).
31.2 *Title of the audiovisual material, if known. If unknown, provide a generic descriptor.
31.3 * Describe the content of the audiovisual material.
31.4 * Indicate the length or the number of items contained in the audiovisual material.
31.5 * Is the material likely to produce psychological discomfort or negative feelings in the
subjects?
31.6 * Upload a copy of the material here.
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If any material is likely to be disturbing, please answer the following:
31.1.1 Describe the arrangements made to provide professional counseling or support
resources to any subjects desiring such assistance as a result of their participation in the
study.
31.1.2 Indicate how the list of counseling or support resources will be provided:
32. Data and Safety Monitoring Plan Required if yes to 7-1.10
32.1 * Indicate who will provide study information and instructions to the subjects beyond
what is included in the informed consent document.
32.2 * Indicate who will obtain informed consent from the subjects. (Note: In situations where
there is a real or perceived conflict of interest, it may be inappropriate for the conflicted
study team member(s) to obtain consent.)
32.3 * Indicate who will collect and record study data.
32.4 * Indicate what mechanism(s) will be used for monitoring subjects and identifying
adverse events.
32-1. Data and Safety Monitoring Plan
32-1.1 * Adverse events will be reported to:
32-1.2 * Indicate the AE reporting timetable that will be used to report adverse events to the
IRB: (NOTE: Clinical studies conducted in schools other than the Medical School should
follow IRBMED reporting guidelines.)
32-1.2.1 Indicate the reason for selecting the study-specific AE reporting rather than the
Standard IRBMED AE Reporting Timetable.
32-1.2.2 Provide the study-specific AE reporting plan. If the study-specific AE reporting
plan is included in the previously uploaded scientific protocol, indicate section.
32-1.3 * Affirm that the adverse events will be reported to the IRB according to the following
generalized AE GRADING SCALE:
0 - No adverse event
1 - Mild AE – No treatment needed
2 - Moderate AE – Resolved with treatment
3 - Severe AE – Inability to carry on normal activities, required professional medical attention
4 - Life-threatening or disabling AE
5 - Fatal AE
32-1.4 * Will Serious Adverse Events (SAEs) be categorized according to the following FDA
definition?
32-1.5 * Affirm that either the principal investigator or a co-investigor will determine the
ATTRIBUTION/RELATEDNESS for each adverse event.
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32-1.6 * Affirm that the EXPECTEDNESS will be assigned for each adverse event according
to the following definitions:
32-2. Data and Safety Monitoring Plan
32-2.1 * Indicate the frequency with which the study team will conduct scheduled
assessments of study recruitment, data integrity and quality, adverse events, withdrawals,
32-2.1.1 If quarterly or other, provide a justification for the assessment schedule.
32-2.2 * Additional monitoring may be required based on the nature, size, and complexity of
the study. Indicate the responsible entities.
If no additional monitoring is required, jump to 32-2.3.
32-2.2.1 Provide the name(s) and area(s) of expertise of those providing this additional
monitoring (e.g., independent monitor, internal committee, Data and Safety Monitoring
Board (DSMB), etc.).
32-2.2.2 Indicate the frequency with which the additional monitoring activities will be
conducted.
32-2.2.3 Indicate the data that will be reviewed.
32-2.2.4 If a DSMB or DSC charter exists, upload it here.
32-2.3 * Monitoring reports will be provided to:
33. Children (Minors under the age of 18)– Required if Children or Viable Neonates selected in 9-1.1 and direct interaction indicated in
5.3
Interaction/Intervention Studies
33.1 * Specify the age range(s) of the children to be included as subjects in this study.
33.2 * For each research activity conducted with children, indicate the member(s) of the
study team that will conduct the activity and briefly describe their expertise with children.
33.3 * Describe the adequacy of the research facilities to accommodate children
participating in this study.
33.4 * Permitted Categories of Research: The federal policy and regulations governing
human subject protections specify that research involving children must fall into one of the
following permitted categories. Check all categories of permitted research that apply to this
study.
33.4.1 * Provide a justification for how the study complies with the selected requirement.
33.5 * Does the study require the involvement of children with any physical or mental
incapacities?
33.5.1 If yes, please describe the mental and/or physical incapacities.
33-1. Children (Minors under the age of 18) – Required if Children or Viable Neonates selected in 9-1.1 and data analysis only (5.2=No and
5.3=Yes)
Secondary Analysis Only Studies
33-1.1 * Permitted Categories of Research: The federal policy and regulations governing
human subject protections specify that research involving children must fall into one of the
following permitted categories. Check all categories of permitted research that apply to this
study.
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31-1.1.1 * Provide a justification for how the study complies with the selected requirement.
34. Neonates of Uncertain Viability and/or Required if Neonates of Uncertain Viability and/or Nonviable Neonates selected in 9-1.1
Nonviable Neonates
34.1 * The federal regulations governing human subject protections specify that research
involving neonates of uncertain viability and nonviable neonates must conform to each of
the following general requirements. For each of the following requirements, indicate HOW
this study complies with the regulations.
34.1.1 * Where scientifically appropriate, preclinical and clinical studies have been
conducted and provide data for assessing potential risks to neonates [45 CFR 46.205
(a)(1)]. Include literature references as applicable in the explanation.
34.1.2 * Each individual providing consent is fully informed regarding the reasonably
foreseeable impact of the research on the neonate. [45 CFR 46.205 (a)(2)].
34.1.3 * Confirm that individuals engaged in the study will have no part in determining the
viability of the neonate [45 CFR 46.205 (a)(3)]. Include the role(s) of the parties that will
make the determination. (e.g. attending pediatrician, etc.)
34.2 * Does this study involve neonates of uncertain viability?
If yes, answer the following three questions. If no, jump to 34.3
34.2.1 The federal regulations governing human subject protections specify that, until it is
ascertained whether or not a neonate is viable, a neonate may NOT be involved in research
unless one of the following conditions is met. Check which conditions apply to this study.
34.2.2 Provide justification of how this study complies with the selected requirement.
34.2.3Affirm that the following regulatory requirements for obtaining informed consent will be
followed.
For research involving ―neonates of uncertain viability‖ the written informed consent of either
parent of the neonate or,
if neither parent is able to consent because of
unavailability,
incompetence, or
temporary incapacity,
the written informed consent of either parent‘s legally authorized representative must be
obtained;
except that the consent of the father or his legally authorized representative need not be
obtained if the pregnancy resulted from rape or incest.
34.3 * Does this study involve nonviable neonates?
If yes, complete the following three questions. If no, scroll to the bottom of this page and
click Continue.
34.3.1 Affirm that ALL of the following regulations will be followed when the neonate is
determined to be nonviable.
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34.3.2 Provide justification of how this study complies with the requirements.
34.3.3 Affirm that the following regulatory requirements for obtaining informed consent will
be followed. [45 CFR 46.205 (c)(4)]
For research involving ―nonviable neonates‖, the full written informed consent of both
parents must be obtained; unless:
One parent is unable to consent because of
unavailability,
incompetence, or
temporary incapacity; or
the pregnancy resulted from rape or incest, then the consent of the father need not be
obtained.
Additionally;
a waiver or alteration of informed consent is not allowed; and
the consent of the legally authorized representative of either or both parents will not suffice.
35. Pregnant Women and/or Fetuses– Required if Pregnant Women and/or Fetuses selected in 9-1.1 and direct interaction indicated
in 5.3
Interaction/Intervention Studies
35.1 * Permitted Categories of Research: The federal regulations governing human subject Add to Section 35-1 for data analysis only
protection specify that research involving pregnant women or fetuses may be conducted in studies
only the following permitted categories.
35.1.1If none of the above categories applies to this research, justify the use of pregnant Add to Section 35-1 for data analysis only
women in this study, then click Continue. studies
35.2 The federal regulations governing human subject protection specify that research
involving pregnant women and/or fetuses must conform to EACH of the following general
requirements. For each of the following requirements, indicate how this study complies with
the regulations.
35.2.1 Where scientifically appropriate, preclinical studies (including studies on pregnant
animals) and clinical studies (including studies on non-pregnant women) have been
conducted and provide data for assessing potential risks to pregnant women and fetuses [45
CFR 46.204 (a)]. Include literature references as applicable in the explanation.
35.2.2 Each individual providing consent is fully informed regarding the reasonably
foreseeable impact of the research on the fetus or neonate [45 CFR 46.204 (f)].
35.2.3 Any risk is the least possible for achieving the objectives of the study [45 CFR 46.204
(c)].
35.2.4 Individuals engaged in the conduct of the study will have no part in determining the
viability of a neonate [45 CFR 46.204 (j)]. Include the role(s) of the parties that will make the
determination. (e.g. attending pediatrician, etc.)
35.3 Confirm that no inducements, monetary or otherwise, will be offered to terminate the
pregnancy [45 CFR 46.204 (h)].
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35.4 Confirm that individuals engaged in the conduct of the study will have no part in any
decisions related to the timing, method, or procedures used to terminate a pregnancy [45
CFR 46.204 (i)].
35.5 Affirm that the following regulatory requirements for obtaining informed consent will be
followed [45 CFR 46.204 (d)&(e)].
For studies involving pregnant women and fetuses, the full informed consent of the pregnant
woman must be obtained.
The father‘s consent must also be obtained if the study holds the prospect of direct benefit
solely to the fetus, unless he is:
unavailable
incompetent,
temporary incapacitated; or
the pregnancy resulted from rape or incest.
If un-emancipated pregnant minors are enrolled in the study, assent and permission
(consent) from their parent or guardian must be obtained. [Completion of Section 33 is
required]
35.6 Is this study designed to include any pregnancies resulting from a rape or incestuous
relationship?
35.7 Will the study involve--after delivery--the placenta, a dead fetus, or fetal material? [45
CFR 46.206 (a&b)]
35.7.1 If yes, affirm that the following regulations are followed [MCLA 333.2685].
35-1. Pregnant Women and/or Fetuses Regulatory Completion of this section is required based on the response provided to question 9-1.1
Categories – Secondary Analysis Only Studies
35-1.1 * Permitted Categories of Research: The federal regulations governing human 1.5 Upgrade - Add to Section 35-1 for data
subject protection specify that research involving pregnant women or fetuses may be analysis only studies
conducted in only the following permitted categories.
35-1.1.1If none of the above categories applies to this research, justify the use of pregnant 1.5 Upgrade - Add to Section 35-1 for data
women in this study. analysis only studies
36. Lactating Women Required if Lactating Women selected in 9-1.1 and direct interaction indicated in 5.3
36.1 * Describe any potential risks from the subject's participation in the study to a nursing
child or any child receiving the subject's milk.
36.2 * What steps will be taken to minimize those risks?
37. Women of Child Bearing Potential Required if Women of Child Bearing Potential selected in 9-1.1 and direct interaction indicated
in 5.3
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37.1 * Do any of the study procedures pose significant physical or psychological risks to text change: Is there a potential that any of the
women who are or may be pregnant, or to a fetus? study procedures pose significant physical or
psychological risks to women who are or may
be pregnant, or to a fetus?".
If no, click Continue.
If yes, please answer the following questions:
37.1.1 List the study procedures that pose risks to pregnant women or fetuses.
Text change:List the study procedures that
may pose risks to pregnant women or fetuses.
37.1.2 Describe the steps that will be taken prior to the conduct of these procedures to
confirm that subjects are not pregnant.
37.1.3 Describe the measures that will be required to prevent pregnancy during or, if
applicable, following subjects' exposure to the study procedures. Specify the duration of the
preventative measures.
38. Prisoners Required if Prisoners selected in 9-1.1
38.1 * Permitted Categories of Research: The federal regulations governing human subject
protection specify that research involving prisoners is permitted in only the following
categories.
The research involves solely a study of the possible causes, effects, and processes of
incarceration, and of criminal behavior; provided that the study presents no more than
minimal risk and no more than inconvenience to the subjects [45 CFR 46.306 (a)(2)(i)].
NOTE: FINAL APPROVAL OF THIS APPLICATION MAY REQUIRE ADDITIONAL
APPROVAL AT THE FEDERAL LEVEL. CONTACT THE IRB OFFICE FOR MORE
INFORMATION.
The research involves solely a study of prisons as institutional structures or of prisoners as
incarcerated persons, provided that the study presents no more than minimal risk and no
more than inconvenience to the subjects [45 CFR 46.306 (a)(2)(ii)]. NOTE: FINAL
APPROVAL OF THIS APPLICATION MAY REQUIRE ADDITIONAL APPROVAL AT THE
FEDERAL LEVEL. CONTACT THE IRB OFFICE FOR MORE INFORMATION.
The research involves solely research on conditions particularly affecting prisoners as a
class (e.g., vaccine trials and other research on diseases or conditions which are more
prevalent in prisons than elsewhere; and research on social and psychological problems
such as alcoholism, drug addiction, and sexual assaults) [45 CFR 46.306 (a)(2)(iii)]. NOTE:
FINAL APPROVAL OF THIS APPLICATION MAY REQUIRE ADDITIONAL APPROVAL AT
38.1.1 * Justify how this study complies with the selected categories.
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38.2 * Describe how any possible advantages for the prisoner through his/her participation in
this study are not of such a magnitude that his/her ability to weigh the risks of participating in
the study against the value of such choices in the prison environment is impaired. Consider
any advantages compared to general living conditions, medical care, quality of food,
amenities, and opportunity for earnings in the prison. [45 CFR 46.305 (a)(2)]
38.3 * Describe how the risks involved in participating in the study are commensurate with
risks that would be accepted by non-prisoner subjects. [45 CFR 46.305 (a)(3)]
38.4 * Describe how the procedures for the selection of subjects within the prison are fair to
all prisoners and immune from arbitrary intervention by prison authorities or prisoners. [45
CFR 46.305 (a)(4)]
38.5 * Does this research involve a control group (a study arm that provides treatment-as-
usual, services-as-usual or the standard medical care that would be available to the prisoner
whether or not he/she participated in the study)? [45 CFR 46.305 (a)(4) and 46.306(a)(2)(iv)]
38.5.1 If yes, describe any additional benefits to subjects in the control group. If none, so
state.
38.6 * Demonstrate that adequate assurance exists that parole boards will not take into
account a prisoner's participation in the study in making decisions regarding parole, and that
each prisoner is clearly informed in advance that participation in the study will have no effect
on his/her parole. [45 CFR 46.305 (a)(6)]
38.7 * Will the research require follow-up examination or care of prisoners involved in the
study?
38.7.1 If yes, describe what provisions have been made to provide the care, taking into
account the varying lengths of prison terms. Include the arrangements to inform prisoners of
this information (e.g., described in informed consent document, etc.). [45 CFR 46.305 (a)(7)]
38.8 Upload applicable documentation, including research policies from the specific prison
facilities involved in the study.
39. Cognitively Impaired Adults Required if Cognitively Impaired Adults selected in 9-1.1 and direct interaction indicated in 5.3
39.1 * Explain the manner and extent to which the adult subjects are cognitively impaired.
Include the transient or permanent nature of any impairment and whether or not the adults
are likely to become permanently incompetent during the course of the study.
39.2 * How will competency be assessed for the purpose of obtaining informed consent?
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39.3 * What measures will be taken to provide the cognitively impaired adult subjects the
opportunity to understand that they have been enrolled in the study and have the right to
object (e.g., the use of any videos, photographs, or involvement of family members)?
39.4 * Should a cognitively impaired adult subject desire to withdraw from the study,
describe the process for managing the transition.
40. College Students Required if College Students selected in 9-1.1 and direct interaction indicated in 5.3
40.1 * How will informed consent be obtained from the parents/guardian of any student
under the age of 18.
41. Subjects Vulnerable to Coercion or Undue Required if Children, Pregnant Women, Prisoner, Cognitively Impaired Adults, College
Students, Disadvantaged persons, Patients, students, or family members of study teams are
Influence selected in 9-1.1 and direct interaction indicated in 5.3
41.1 * What is the justification for the inclusion of these subject populations?
41.2 * Describe the additional safeguards that have been included in this study to protect the
rights and welfare of these subjects. Include the measures that will be taken to minimize any
potential coercion or undue influence in recruitment and ongoing participation in the study.
42. General Clinical Research Center (GCRC) Required if GCRC is selected in 1-1.5
Resources
42.0 * Select your study type: GCRC 1.5 Upgrade - New Question
Category A - Research Subjects Stays or visits are solely for research purposes GCRC
Research was initiated by the investigator
GCRC grant or P.I.‘s research grant is responsible for all hospitalization costs
Includes rare diseases/orphan studies
Category B – Research Service Subjects Subjects require visits or stays for diagnosis or GCRC
treatment and are participating in research
Subject or insurance is responsible for cost of standard of care services (i.e. non-research
care)
Ancillary services that are performed solely for research are charged to the GCRC and do
not appear on the subject‘s hospital bill
Category A & B For Multi-Arm studies only, where at least one arm is category A and at GCRC
least one arm is category B (see above definitions)
Category D – Industry-Initiated Research Research was initiated by industry GCRC
Industry is responsible for all charges
Study account has its own 7000 account number, project/grant number and shortcode
42.1 * Indicate all resources that are being requested from the GCRC. Select all that apply GCRC
42.1.1 Inpatient-total number of GCRC stays needed (number of subjects times number of GCRC
days):
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42.1.1.1 Specialized Beds Needed: (Select all that apply and indicate number) GCRC
42.1.1.2 Inpatient Nursing Intensity GCRC
42.1.2 Outpatient-Total GCRC Visits (number of subjects times number of visits): GCRC
42.1.2.1 Select all that apply and indicate number GCRC
42.1.2.2 Outpatient Average Duration of Visit: GCRC
42.1.2.3 Outpatient Nursing Intensity GCRC
42.1.2.4 Nurse Practitioner/Physician Assistant Required GCRC
42.1.3 Hospital stays/visits outside GCRC unit: GCRC
42.1.4 GCRC-Supplied Equipment GCRC
42.1.5 Bionutritional Services GCRC
42.1.6 Human Applications Laboratory (HAL) GCRC
42.1.7 Specimen processing core laboratory GCRC
42.1.7.1 Explain any special handling or shipping. GCRC
42.1.8 Biomedical Imaging Core GCRC
42.1.8.1 Download and complete the BIC application form for CTC, fMRI, MRI, PET and GCRC
attach below. (Click here to download the form in RTF format.)
42.1.9 Informatics Core GCRC
42.1.10 Biostatistical Consulting Service GCRC
42.2 * Provide the justification for utilization of GCRC resources. GCRC
42-1. GCRC Information Required if GCRC is selected in 1-1.5
42-1.1 * Scientific Abstract: (Do NOT copy information from question 4.1) GCRC
42-1.2 * Upload GCRC Budget. (NOTE: THE GCRC BUDGET TEMPLATE HAS BEEN GCRC
UPDATED. Click here to download the form in Microsoft Excel format.) Also, verify that a
Sponsor Budget has been uploaded in section 2.
42-1.3 * Upload schedule of visits and procedures (time and events table). Download GCRC
example (link to Microsoft Word document) and modify, or insert your own spreadsheet
here. List your tests, procedures and visits/nights for your protocol and specify whether
subjects will be inpatients or outpatients. Check that your table matches your protocol
narrative, GCRC requested resources, informed consent document and your draft doctor‘s
orders. Change this table whenever you amend your protocol.
42-1.4 Inclusion in National Library of Medicine database. The National Center for Research GCRC
Resources is requiring studies without other NIH or industry funding to submit information for
a national database of clinical trials. The National Library of Medicine is creating this
database. Please provide a contact person for potential subjects and the general public who
want to obtain more information about the study:
42-1.5 * How will the final research data be shared? Sharing information via publication is GCRC
expected.
42-1.6 * Is this a Phase I trial involving HIV or AIDS? GCRC
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43. MADRC Clinical Core Resources Required if MADRC is selected in 1-1.5
43.1 * Will the Michigan Alzheimer's Disease Research Center (MADRC) be used to identify MADRC
subjects?
43.2 * Types of subjects needed (age range, diagnosis, exclusions, etc.): MADRC
43.3 * Total number of subjects needed: MADRC
43.4 If neuropsychometric test data are required or testing is needed, please specify: MADRC
43.5 * Will the use of other MADRC resources be requested (Education Core, Biostatistics MADRC
Core)?
43.5.1 If so, please describe: MADRC
43.6 * Affirm that the PI has received a copy of the Policy for Michigan Alzheimer's Disease MADRC
Research Center (MADRC) Core Support and agrees to abide by the conditions stated
therein (link to PDF):
44. Additional Supporting Documents
44.1 Please upload any additional supporting documents related to your study that have not
already been uploaded. Examples include, but are not limited to, data collection sheets,
newsletters, subject brochures, and instructional brochures
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