Form 31 Adult CIRB Reviewer Findings Continuing Review of Cooper

Attachment 6G:

NCI Adult CIRB
REVIEWER FINDINGS
CONTINUING REVIEW OF 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 30 minutes 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
CONTINUING REVIEW OF 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/Pediatric CIRB Application for Continuing Review
Study Protocol
Cooperative Group Model Informed Consent Document(s)
CIRB Approved Informed Consent Document(s)
DSMB/Safety Monitoring Committee Report
Toxicity Summary
Presentations or publications for the study
Relevant information relating to participants’ risks and benefits
Management plan to address new or revised conflicts of interest
Other (specify)

2. Are there any important changes in the risks, benefits, or protocol
schedule that you believe have an impact
on the CIRB's approval of this protocol?
Yes
No

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3. In your judgment, do the benefits of this study continue to outweigh the
risks?
Yes
No
Uncertain
4. Do you recommend that the CIRB approve continuation of this study?
Yes
No
Uncertain
5. Additional Remarks

FINAL 04/07/10

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