IUPUI AND CLARIAN INSTITUTIONAL REVIEW BOARDS _ SUBCOMMITTEES REVIEWS by hcj

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									            IUPUI AND CLARIAN INSTITUTIONAL REVIEW BOARDS & SUBCOMMITTEES REVIEWS
                           NCI CIRB FACILITATED REVIEW COVER SHEET

                                                                                                                                          Principal Investigator:
                                                                                                                                       Local IRB Study Number:
                                                                                                                                                Document Date:

Please type only in the gray boxes. To mark a box as checked, double-click the box, select “checked”, and click “OK”.
                                             S ECTIO N I: INVESTIGATO R INFORMATION
Principal Investigator:                                                                                                     Department:
                          ( Last, First, Middle Initial------must have faculty/staff status or faculty sponsor must sign)
Building/Room No.:                                                                 Phone:                                    E-Mail:
Contact Information:
Name:                                            Address:                                                                    Phone:
                                                 Fax:                                                                        E-Mail:
Protocol Ti tle:
Cooperati ve Group:                                                                                           Study Identifier:

                                                              S ECTIO N II: TYP E O F S UBMISSION


     Continuing Review. Co mp lete Section III.
     Amendment. Co mp lete Section IV.
     Prompt Reporting Event. Co mp lete Section V.
     Other. Please describe:      .

Has this item been submitted to and approved by the CIRB?
           Yes
           No. This item will not be reported to and reviewed by the CIRB.
           No. This item will be reviewed by the CIRB and documentation will be provided to the local IRB.

The following documents are attached:
         CIRB Approval                                                                                        Assent
         NCI CIRB Facilitated Rev iew Form                                                                    Protocol
         In formed Consent/Authorization                                                                      Other:

                                                             S ECTIO N III: CO NTINUING REVIEW
1.     Since the last IRB review, did any unanticipated problems, including adverse events, protocol deviations, or subject
       complaints, or noncompliance occur on-site that required prompt reporting to the IRB?
           No.
           Yes. Were these events reported previously to the IUPUI/ Clarian IRB?
               No. Please exp lain why these events were not previously reported:
               Yes. Provide a summary of these events:
                    Check here if the summary is attached.

2.     Since the last IRB review, did any unanticipated problems, including adverse events, protocol deviations, or subject
       complaints, or noncompliance occur on-site that did not require pro mpt reporting to the IUPUI/Clarian IRB?
           No.
           Yes. Provide a summary of these events:
                    Check here if the summary is attached.

3.     If any recent literature has been published or presented by you or others since the last IRB rev iew, has it demonstrated a
       significant impact on the conduct of the study or the well-being of subjects?
            N/A. There has not been any recent literature published or presented since the last IRB review.
            No.
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           Yes. Attach a copy or exp lain :

4.     Have there been any audits from federal agencies conducted since the last IRB review that identified unanticipated problems
       involving risks to local subjects or others or noncompliance?
           No.
           Yes. Attach the report(s).


                                                         S ECTIO N IV: A MENDMENT

This change affects the     informed consent,        assent, or    both.

NOTE: if the proposed change(s) does not affect the informed consent or assent documents, the IUPUI/Clar ian IRB does NOT need to
review the amendment.

     The new info rmed consent and/or assent document(s) are in addition to the current one(s).
     The new info rmed consent and/or assent document(s) replace the current one(s).
     If there are mu ltiple consent and/or documents for this study, please indicate which consent and/or assent document(s) are to be
     replaced.

     Enro lled subjects will be info rmed of the change(s) described in this amend ment.
         Reconsent and/or re-assent
         Other:
     Enro lled subjects will not be informed of the change(s) described in this amend ment. Please explain why not:


                                                 S ECTIO N V: PRO MPT R EPORTING EVENT

For additional informat ion and definitions, see the Unanticipated                          Problems       and    Noncompliance         SOP     at
http://www.iupui.edu/~respoly/human-sop/human-sop-index.htm.

R EPORT TYPE:
A.     Adverse Event that meets the following criteria:

              Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the
              protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the
              characteristics of the subject population being studied;
              Related or possibly related to participation in the research (i.e., there is a reasonable possibility (more likely than not)
              that the incident, experience, or outco me may have been caused by the procedures involved in the research);
              Suggests that the research places subjects or others at a greater risk of harm (including ph ysical, psychological,
              economic, or social harm) than was previously known or recognized . Please note that such events routinely warrant
              consideration of substantive changes in the research protocol or informed consent process/document or other corrective
              actions in order to protect the safety, welfare, or rights of subjects or others ;
              Requires changes to the research protocol or informed consent process/document or other corrective actions in order to
              protect the safety, welfare, or rights of subjects or others.

         NOTE: If the adverse event does not meet all four (4) criteria listed above, the event should not be reported to the IRB on this form. It
         should, however, be reported at the time of continuing review. Please note that the IRB is required to report any unanticipated problem to
         institutional officials and regulatory agencies (i.e. OHRP, FDA), as appropriate.

B.       Major Protocol Deviat ion (A deviation that may impact subject safety, affect the integrity of study data and/or affect
         subject’s willingness to participate in the study. Examp les: Enrollment of a subject who did not meet all inclusion/ exclus ion
         criteria; performing a study procedure not approved by the IRB; drug/study medication dispensing or dosing error; or failure
         to perform a required lab test or conducting a study visit outside the required timeframe, if, in the opinion of the investigator,
         may affect subject safety and/or data integrity). Only internal major p rotocol violations should be reported to the IRB.

C.       Change to the IRB-approved protocol taken without prior IRB rev iew to eliminate apparent immed iate hazard to a research
         subject(s) (e.g. purposeful and for subject safety). On ly internal protocol changes should be reported to the IRB.
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D.       Co mplaint of a subject that indicates unexpected risks or that cannot be resolved by the research team. Only internal subject
         complaints should be reported to the IRB.

E.       Publication in the literature, safety monitoring report, interim result, or other find ing that indicates an unexpected change to
         the risks or potential benefits of the research, in terms of severity or frequency.

F.       Change in FDA labeling or withdrawal fro m marketing of a drug, device, or b iologic used in a research study.

G.       Unanticipated Adverse Device Effect (Any serious adverse effect on health or safety or any life-threatening problem or death
         caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or
         degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other
         unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects ).

H.       Investigator- or Sponsor-init iated study suspension or hold.

I.       Other: Please explain:


EVENT INFO RMATIO N:
1. Date of Event:                                                  Date Notified of Event:
2. Event Site:                  On-site (IUPUI/Clarian subject) Subject ID (if applicab le):
                                External Site

3.   Event Report:              Initial Report
                                Follow-up Report

4. Provide a description of the event and explain why it is determined to be an unanticipated problem (i.e. how does it meet the
   criteria for an unanticipated problem?):
5. Exp lain the corrective measures taken as a result of this event and the preventive measures to be taken to prevent the event from
   occurring in the future (if possible), how the event was (or will be) resolved, and whether the sponsor was notified of the event (if
   applicable):

PRO POSED ACTIO N: Please indicate any actions that will be taken as a result of this report:

1.       The informed consent process/document will be revised. This is required for an adverse event that is not consistent with the
         current informed consent document and/or available literature (e.g. drug brochure, protocol, publications), including its
         severity and/or frequency. Please submit an amendment requesting the revisions. If the amendment cann ot be submitted at
         this time (e.g. requires sponsor approval first), p lease explain:
         The informed consent document will not be revised. Please explain:

2.       The protocol will be rev ised. Please submit an amend ment requesting the revisions. If the amend ment cannot be submitted at
         this time (e.g. requires sponsor approval first), p lease explain:
         The protocol will not be revised. Please exp lain :

3.       Currently enro lled subjects will be notified. Please attach a copy of the notification.
         Currently enro lled subjects will not be notified. Please exp lain :

4.       Other corrective and/or preventive action will be taken. Please exp lain :

5.       The event compromised the validity of the data. Please exp lain :
         The event did not co mpro mise the valid ity of the data. Please explain:




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                                    S ECTIO N VI: INVESTIGATO R S TATEMENT O F CO MPLIANCE
By submitting this form, the Principal Investigator assures the Board that all procedures performed under the project will be conducted
in strict accordance with those federal regulations, University and Clarian Health Partners policies that govern research involving
human subjects. He/she agrees to submit any local deviation fro m the project (e.g. change in principal investigator, research
methodology, subject recruit ment procedures, etc.) to the Board in the form of an amendment for IRB approval p rior to
implementation. He/she further agrees to submit evidence of NCI CIRB act ions to the Board.

                                                   S ECTIO N VII: IRB APPRO VAL
This protocol, informed consent statement, authorization, and/or waiver of authorizat ion for use of human subjects in research has
been reviewed and approved by the Indiana University -Purdue University Indianapolis Institutional Rev iew Board or the Clarian
Institutional Review Board for a maximu m o f a one year period beyond the final approval date unless otherwise indicated below.

Reviewed by:
       Dr. Conrad Johnston
       Dr. Nasser Hanna
       Dr. Chris Fausel
       Dr. Rakesh Mehta

Prompt Reporti ng Event

             Report does NOT represent an unanticipated problem. Sign report and return to investigator.

             Report likely represents an unanticipated problem. Refer to convened IRB .

IRB Chair or designee Signature:                                                                            Date:


Report sent to convened IRB for review. See IRB meeting minutes for additional informat ion.

             The report represents an unantici pated problem.

             The report does NOT represent an unanticipated problem.

IRB Signature:                                                                                Date:
Recorded in the Minutes of:

Continuing Review/ Amendment/ Other

             Approved as submitted. The NCI/CIRB facilitated review process is accepted.

             Approved with Provisions

             Not Approved. This protocol must undergo full board review and is NOT accepted fo r NCI CIRB facilitated review.



IRB Approval Date:

Authorized IRB Signature:                                                        Signature Date:

CIRB Exp iration Date:




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