Form 29 Adult CIRB Reviewer Findings Amendment Cooperative Group

Attachment 6E:
NCI Adult CIRB
REVIEWER FINDINGS
AMENDMENT TO COOPERATIVE GROUP PROTOCOL

OMB#: 0925 – xxxx Expiry Date: xx/xx/xxxx
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. While your participation is
completely voluntary, to participate in the NCI CIRB, completion of this form is required. Data
collected as part of the NCI CIRB review is private and protected by law. Under the provisions of
Section 301d of the Public Health Service Act, no information that could permit identification of a
participating individual may be released. All such information will be kept private under the
Privacy Act and will be presented only in statistical or summary form.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 1.5 hours per
response, including the time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information. An
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comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705
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return the completed form to this address.

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NCI Adult CIRB
REVIEWER FINDINGS
AMENDMENT TO COOPERATIVE GROUP PROTOCOL
DOCUMENT NAME:
DOCUMENT DESCRIPTION:
Name of Reviewer:
Date Completed:

1. I have reviewed the following documents (check all that apply)
NCI Adult CIRB Application for Treatment Studies or NCI Adult/Pediatric CIRB
Application for Ancillary Studies
Summary of CIRB Application Revisions
Summary of Changes related to the Amendment
Study Protocol
Cooperative Group Model Informed Consent Document(s)
CIRB Approved Informed Consent Document(s) with changes incorporated
Other (specify)

2. The amendment includes the following changes (check all that apply)
Increase or decrease in accrual (impacts statistical design)
Addition or deletion of a treatment group/arm
Addition or deletion of a study drug
Change in treatment period/treatment design
Changes in the informed consent document(s)
Editorial and/or administrative changes
Other (specify)

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3. Please provide a brief summary of the current approved protocol. (Note to
reviewer: Not applicable for amendments containing solely editorial and/or
administrative changes)

4. Please provide the rationale for the amendment. (Note to reviewer: Not
applicable for amendments containing solely editorial and/or administrative
changes)

5. Do the changes in the amendment alter the risk/benefit ratio to the
participants?
If yes, explain
No
6. In your judgment, do the benefits of this study continue to outweigh the risks?
Yes
If no, please explain
If uncertain, please explain

7. Please provide your comments and/or concerns regarding the amendment.

8. Please provide your recommendation for CIRB action on the amendment.

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