Form 43 Adult & CPC FB SCRWksht

NCI Choose 1
REVIEWER WORKSHEET
STUDY CHAIR’S RESPONSE TO CIRB REVIEW
OMB# 0925-0753, Expiration Date: 07/31/2021

Attachment_B27_Adult_Resp_Rev

The purpose of the information collection is to conduct reviews of clinical trial studies. NCI guidelines mandate the participation of institutions in the
CIRB for Network group studies. You are being requested to complete this instrument so that we can conduct activities involved with the operations of
the NCI CIRB Initiative. Although your participation in Network group research and completion of the forms is voluntary, if you wish to participate in the
CIRB, you must complete all questions on the form. The information you provide will be combined for all participants and reported as summaries. It will
be kept private to the extent provided by law.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 60 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 (0925-0753). Do not return the completed form to this address.

STUDY ID:
STUDY TITLE:
NAME OF CIRB REVIEWER:
DATE COMPLETED:

1.

The Study Chair’s 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):
Study Chair’s Response Letter/Memo
Revised Protocol Version
Revised Model Informed Consent Document(s)
Revised NCI Adult CIRB Application for Treatment Studies or NCI Adult/Pediatric
CIRB Application for Ancillary Studies
Summary of CIRB Application Revisions
Other (specify):

July
201810/12/2016, updated 07/07/2017
Version

3.

Has the Study Chair adequately addressed the CIRB stipulations and/or
recommendations from the prior CIRB review?
Yes
No

4.

Did the Study Chair’s 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.

Do the additional changes alter the risk/benefit ratio to the participants?
Yes
No

6.

Please provide your comments and/or concerns (if any) regarding the Study
Chair’s response and revised documentation.

7.

Please provide your recommendation for CIRB action on the Study Chair’s
response and revised documentation.

8.

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.

9.

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 decisionmaking is appropriate).

10.

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.

11.

Recommendations

July 2018

Version 10/12/2016, updated 07/07/2017

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.

July
2018
Version
10/12/2016, updated 07/07/2017