Form 27 Adult CIRB Reviewer Findings Cooperative Group Response

Attachment 6C:

NCI Adult CIRB
REVIEWER FINDINGS
COOPERATIVE GROUP RESPONSE TO CIRB REVIEW

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 hour 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
agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. Send
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
Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not
return the completed form to this address.

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

1. This Cooperative Group response is in reference to (check one):
CIRB Stipulations from Initial Review
CIRB Stipulations from Amendment/Revision/Update Review
CIRB Stipulations from Continuing Review
2. I have reviewed the following documents (check all that apply):
Cooperative Group Response Letter/Memo
Revised Study Protocol
Revised Cooperative Group Model Informed Consent Document(s)
CIRB Approved Informed Consent Document(s) with changes
incorporated
Revised NCI Adult CIRB Application for Treatment Studies or NCI
Adult/Pediatric CIRB Application for Ancillary Studies
Revised Summary of CIRB Application Revisions
Other (specify):

3. Has the Cooperative Group and/or Study Chair adequately addressed
the CIRB stipulations and/or recommendations
from the prior CIRB review?

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Yes
No
4. Did the Cooperative Group response include additional changes aside
from the CIRB stipulations
and/or recommendations?
Yes (If yes, check all that apply below)
No (If no, skip to Question 6)
5. If "yes" to Question 4, above, check all below that apply.
Change in treatment period/design
Change in statistical design
Additional changes in the informed consent document(s)
Editorial and/or administrative changes
6. Briefly described the changes indicated above.

7. Do the additional changes alter the risk/benefit ratio to the participants?
Yes
No
8. Please provide your comments and/or concerns (if any) regarding the
Cooperative Group response and revised documentation.

9. Please provide your recommendation for CIRB action on the
Cooperative Group response and revised documentation.

FINAL 04/07/10

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