Form 35 Adult AR FB Reviewer Worksheet

NCI Adult CIRB- Choose 1

REVIEWER WORKSHEET
Amendment to Cooperative Group Protocol

OMB #0925-xxxx Expiration Date: xx/xx/xxxx
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STUDY ID:
STUDY TITLE:
NAME OF CIRB REVIEWER:
DATE COMPLETED:
1.

I have reviewed the following documents (check all that apply):
NCI Pediatric 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)
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)

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Editorial and/or administrative changes
Other:
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 whether the benefits continue to outweigh the risks.:
No
If Uncertain, please explain:

6.

Do any of the changes in this amendment include significant new findings
that might relate to the participant’s willingness to continue participation in
the research?
If Yes, describe what plans are included to notify/re-consent participants
and indicate whether the plans are sufficient.:
If No, please explain:

7.

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

8.

Please provide your recommendation for CIRB action on the amendment.

9.

Questions for the Study Team
Questions included below will be sent to the Study Team in advance of the CIRB
meeting. Whenever possible, CIRB Operations Office staff will forward responses
received prior to the meeting to the primary reviewers and post those responses
in ePanel. In order to ensure questions are sent to the Study Chair, questions
should be posted here in ePanel at least 36 hours prior to the CIRB meeting.

10.

Topics for CIRB Discussion
List below any topics requiring discussion among the CIRB members prior to a
final assessment of the study (e.g. whether inclusion of individuals with impaired
decision-making is appropriate).

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11.

Proposed Stipulations
Changes or additional information that the CIRB requires before the study can be
approved should be listed below. The changes or requested information must
pertain to the regulatory criteria for approval or have a direct impact on the
protection of study participants.

12.

Recommendations
List recommended changes below. Recommended changes do not relate to the
regulatory criteria for approval nor do they relate to protection of study
participants. The Study Chair may opt to address the recommendations, or may
disregard them.

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