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University of Connecticut Health Center
ADDENDUM TO APPLICATION TO REQUEST
CONTINUATION OF PREVIOUSLY APPROVED PROJECT
(May also include request for modifications)
Return to IRB Office, Munson Road, 2nd Floor, MC-3926
Note to Research Personnel: Please refer to the request for continuation addendum instructions when
completing this document. Cells will expand to accommodate text. Tab out of the bottom right cell in a
table within a cell to add another row. You may print the document in color or in grey scale. This form
must be appended to the complete application for initial or continuing review.
Note to IRB Members: Any member may request to see any documents, including minutes of previous
meetings, relevant to a continuation application.
SECTION 1 - BASIC STUDY INFORMATION
1.0 IRB #:
1.1 Name of Principal Investigator:
1.2 Complete Project Title:
SECTION 2 – SUBJECT ENROLLMENT DATA
2.0 Is enrollment data available for this study ( if no, explain why (e.g. chart review study, recruitment has not started because…)and
skip to section 3, if yes answer all questions in this section)?
2.1 Provide the number of subjects currently approved for enrollment at or by UCHC:
2.2 Provide the number of subjects enrolled at or by UCHC in the past year (if > 0 attach enrollment breakout form):
2.3 Provide the number of subjects enrolled at or by UCHC since the initiation of the trial:
2.4 Provide the number of subjects enrolled nationally:
2.5 Is the study open for new enrollment?
2.6 If the study is closed to enrollment, did this occur prior to reaching recruitment goals? If yes
explain why and how it impacts the study design.
2.7 Indicate whether currently enrolled subjects are still receiving the study intervention
2.8 Provide the number of UCHC subjects withdrawn since the initiation of the trial:
2.9 Provide explanations for withdrawals:
SECTION 3 - STUDY SUMMARY AND PROGRESS REPORT
3.0 Provide the version reference of the most recently approved protocol:
3.1 Provide the version reference of the most recently approved consent:
3.2 Provide a summary (in date order) of modifications approved since the last continuation, noting
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the date of approval:
3.3 Provide a progress report of the study describing the status of the research (e.g. recruitment
efforts, clinical findings, the results obtained to date. Include local progress information as well as
national progress for multi-center trials):
3.4 Provide a statement as to whether there are any new findings that may impact a participant’s
willingness to continue in this study:
3.5 If there have been significant finding that may impact a participant’s willingness to continue to
participate, describe how those findings have been communicated to the participants:
3.6 Provide a summary of any recent pertinent literature.
3.7 Provide a summary of the findings of the data safety monitoring plans/board meetings and the date
of the last DSMB meeting.
3.8 Provide a description of any benefits experienced by subjects since the previous review:
3.9 Provide a current risk-subject benefit-societal benefit assessment based on the study results to date
and indicate whether this analysis has changed since the last IRB review:
Risk Assessment X Benefit to Subject Assessment X Benefit to Society Assessment X
None None None
Minimal Potential Potential
Minor Increase Direct Direct
Over Minimal
Moderate Potential in the Future Potential in the Future
High
Explain any changes in the risk or benefit assessment:
SECTION 4 – SUMMARY OF REPORTABLE EVENTS
4.0 Provide a summary of all subject complaints (excluding adverse events) that occurred in the last
year and how they were resolved:
4.1 Provide a summary of all unanticipated problems involving risks to subjects or others that
occurred in the last year, including adverse events that meet the definition of unanticipated
problems:
4.2 Indicate whether the profile (i.e. frequency, severity or specificity) of adverse events differs from
that expected at the outset of the research:
4.3 Provide a summary of any instances of non-compliance since the last continuation and, if
applicable, describe the corrective action taken:
4.4 Provide a brief summary of the results of any audits (by internal or external personnel) of the
study that have occurred since the last continuation. In the summary include the dates of the
reports and the dates submitted to the IRB. If not previously provided to the IRB, either directly
4/6/10, 11/23/2009, 10/2009, 12/24/08, 5/7/07, 1/8/06, 8/15/05, 5/26/05, 3/29/2005
by the PI or by copy of the material to the IRB, attach the official report:
4.5 Provide a summary of any multi-center trial reports:
SECTION 5- ADDITIONAL INFORMATION
5.0 Place an X after the method(s) for addressing HIPAA within this study:
HIPAA Authorization Waiver of Authorization for the entire
study
Certification of De-identification Waiver of Authorization for screening
only
Limited Data Set & Data Use No PHI involved with study
Agreement
SECTION 6 – PROPOSED MODIFICATIONS
6.0 Are you proposing a request for modification with this request for continuation? (If yes, complete this
section. If no, skip to Section 7.)
6.1. Indicate the category(ies) of the proposed modification: Direction: Place an X after all that apply.
You may provide additional comments to further explain the request.
Category of Modification X Comment
administrative
clinical with no increased risk to subjects
clinical with increased risk to subjects.
6.2 Place an X after the box(es) that describe the type of modification being requested. Direction:
Check all that apply.
Type of Modification X Type of Modification X
change in informed consent form change in UCHC enrollment
change in protocol change in sponsor/funding source
change to or new recruitment material change investigators/coordinator
change to HIPAA authorization changes to study title
requested as the result of an adverse event change(s) to application
designate personnel to obtain consent other
6.3 If proposing a consent change, provide the revised version reference:
6.4 If proposing a protocol change, provide the revised version reference:
6.5 Describe any proposed changes to investigators, coordinators, individuals authorized to obtain
consent, or contact persons in detail.
Tabbing out of the last cell on the lower right will insert another row.
Add , Last Name, Role in Study Institutional Assurance # Degrees License Type Function(s) in
Change First Name (LIMIT to., PI, co- Affiliation (if not UCHC) Held and # / Study (e.g.
or investigators, (if not UCHC) (for additions Certifications analysis, consent,
Remove coordinator, contact (e.g. MD/000000) procedures)
person, or consenter)
4/6/10, 11/23/2009, 10/2009, 12/24/08, 5/7/07, 1/8/06, 8/15/05, 5/26/05, 3/29/2005
6.6 Describe all proposed changes (excluding staff changes noted in 6.5), including changes in the
application, protocol, consent form etc. in detail and when applicable submit revised
documentation.
6.7 For clinical modifications involving INDs or IDEs, provide the date of correspondence with the
FDA clinical reviewer and attach the correspondence.
SECTION 7– COMMENTS FROM PRINCIPAL INVESTIGATOR
7.0 Provide any additional comments that may be helpful to the IRB in evaluating this project for
continuation:
4/6/10, 11/23/2009, 10/2009, 12/24/08, 5/7/07, 1/8/06, 8/15/05, 5/26/05, 3/29/2005
Enrollment Breakout Form:
Pertaining to Question 2.2
If there has been any enrollment since the last IRB review, you must complete this section. Report overall
enrollment for the study since initial approval was granted. If projected enrollment numbers were provided at
the time of initial approval (i.e. anticipated recruitment was for 250 or more subjects and initial approval was
granted during the fall of 2004), provide the actual enrollment in comparison to the projected enrollment (e.g. of
actual/projected 5 / 20).
If projected numbers were not provided at the time of initial approval simply provide actual enrollment
numbers. Include subjects who enrolled and subsequently withdrew from the study or who completed the
research and are no longer active subjects. If subjects did not self-identify investigators may assign a
categorization based on their opinion. If the PI is making the determination this should be explained in
summary format in the additional comments section.
Ethnic Category Sex/Gender
Females Males Total
Enrolled / Enrolled / Enrolled /
Projected Projected Projected
Hispanic or Latino
Not Hispanic or Latino
Total
Racial Category Sex/Gender
Females Males Total
Enrolled / Enrolled / Enrolled /
Projected Projected Projected
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
(
Other/ Unknown:
Total
Additional Comments:
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NON-COMPLIANCE FORM
PI Name: IRB #: Current UCHC Enrollment: Study Drug or Intervention:
Title (required only when report is submitted apart from continuation form):
Events that may be considered non-compliance that occur within the control of the research team must be reported to the IRB Office within five business days of becoming aware of the event and at
the time of continuing review.
Non-compliance is defined as any action that is taken or occurs that is not in accordance with an IRB approved study, IRB policies or regulations or failure to follow the requirements and
determinations of the IRB. Non-compliance may be minor (e.g. a participant is one day late for visit due to family emergency and there is no impact on the safety of the participant due to the late
visit) or it may be considered serious or continuing.
Noncompliance is considered serious when it creates increased risks to subjects, adversely affects the rights and welfare of the subjects, or affects the scientific integrity of a study. Willful violations
of IRB policies and /or Federal regulations including those pertaining to obtaining informed consent, reporting of adverse events, and disclosure to subjects of conflicts of interests and risks associated
with a study are also considered serious noncompliance. The IRB will make the final determination as to what constitutes serious noncompliance.
Noncompliance is considered to be continuing noncompliance when a pattern of non-compliance exists that if allowed to continue is likely to increase the risks to subjects, adversely affect the rights
and welfare of subjects, or affect the scientific integrity of the study. It may involve the same mistake being made repeatedly within one study or across studies (e.g. a co-investigator on two of the
PI’s approved studies fails to document subject consent) or the same mistake being made after a corrective plan has been issued to the investigator for previous findings of non-compliance. The IRB
will make the final determination as to what constitutes continuing non-compliance.
Complete the table below, deleting the example information prior to submission to the IRB. For reports that were previously filed with the IRB, indicate whether the determination of the IRB was
serious non-compliance, continuing-non compliance, or non-reportable non-compliance (i.e. neither serious or continuing non-compliance). Tabbing out of the cell at the bottom right of the table will
insert another row. Add any comments that you think will be helpful to the IRB (attachments are acceptable).
[DELETE THIS SENTENCE AND THE FOLLOWING EXAMPLE TEXT INFORMATION PRIOR TO SUBMITTING TO THE IRB]
Date of Description of Individual Reason Corrective Action Date Previously Comments/Outcomes
Occurrence & Protocol Deviations Taken Reported to IRB &
Subject ID IRB determinations
Example: Subject 2 days late for follow- Subject canceled original None- not within NA –
1/12/04 up appt. scheduled for 1/10/04 appointment due to family control of the research
#324 emergency team
Example: Wrong dosage of IND Co-Investigator referred to PI held discussion 2/11/2004 Patient was given drug to
2/10/04 administered to subject wrong version of the protocol with investigator, old serious non- counteract overdose and
#567 versions clearly compliance responded well without further
marked as such and incident. IRB did not require
kept apart from most any additional corrective action
recent version. PI will beyond that implemented by the
discuss all PI. .
modifications with
study personnel upon
IRB approval.
4/6/10, 11/23/2009, 10/2009, 12/24/08, 5/7/07, 1/8/06, 8/15/05, 5/26/05, 3/29/2005
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