Form 53 Reviewer Worksheet SCR ER

NCI Choose 1
REVIEWER WORKSHEET
Expedited Review of
Study Chair Response to CIRB-Required Modifications

OMB #0925-xxxx Expiration Date: xx/xx/xxxx
ŽůůĞĐƚŝŽŶŽĨƚŚŝƐŝŶĨŽƌŵĂƚŝŽŶŝƐĂƵƚŚŽƌŝnjĞĚďLJdŚĞWƵďůŝĐ,ĞĂůƚŚ^ĞƌǀŝĐĞĐƚ͕^ĞĐƚŝŽŶϰϭϭ;ϰϮh^ϮϴϱĂͿ͘ZŝŐŚƚƐŽĨLJŽƵƌƉĂƌƚŝĐŝƉĂƚŝŽŶ
ŝŶƚŚĞE//ZŝƐƉƌŽƚĞĐƚĞĚďLJdŚĞWƌŝǀĂĐLJĐƚŽĨϭϵϳϰ͘WĂƌƚŝĐŝƉĂƚŝŽŶŝƐǀŽůƵŶƚĂƌLJ͕ĂŶĚƚŚĞƌĞĂƌĞŶŽƉĞŶĂůƚŝĞƐĨŽƌŶŽƚƉĂƌƚŝĐŝƉĂƚŝŶŐŽƌ
ǁŝƚŚĚƌĂǁŝŶŐĨƌŽŵƚŚĞE//ZĂƚĂŶLJƚŝŵĞ͘ZĞĨƵƐĂůƚŽƉĂƌƚŝĐŝƉĂƚĞǁŝůůŶŽƚĂĨĨĞĐƚLJŽƵƌďĞŶĞĨŝƚƐŝŶĂŶLJǁĂLJ͘dŚĞŝŶĨŽƌŵĂƚŝŽŶĐŽůůĞĐƚĞĚ
ǁŝůůďĞŬĞƉƚƉƌŝǀĂƚĞƚŽƚŚĞĞdžƚĞŶƚƉƌŽǀŝĚĞĚďLJůĂǁ͘EĂŵĞƐĂŶĚŽƚŚĞƌŝĚĞŶƚŝĨŝĞƌƐǁŝůůŶŽƚĂƉƉĞĂƌŝŶĂŶLJƌĞƉŽƌƚŽĨƚŚĞE//Z͘
/ŶĨŽƌŵĂƚŝŽŶƉƌŽǀŝĚĞĚǁŝůůďĞĐŽŵďŝŶĞĚĨŽƌĂůůƉĂƌƚŝĐŝƉĂŶƚƐĂŶĚƌĞƉŽƌƚĞĚĂƐƐƵŵŵĂƌŝĞƐ͘zŽƵĂƌĞďĞŝŶŐƌĞƋƵĞƐƚĞĚƚŽĐŽŵƉůĞƚĞƚŚŝƐ
ŝŶƐƚƌƵŵĞŶƚƐŽƚŚĂƚǁĞĐĂŶĐŽŶĚƵĐƚĂĐƚŝǀŝƚŝĞƐŝŶǀŽůǀĞĚǁŝƚŚƚŚĞŽƉĞƌĂƚŝŽŶƐŽĨE//Z/ŶŝƚŝĂƚŝǀĞ͘
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-cccc*). Do not return the completed form to this address.

STUDY ID:
STUDY TITLE:
PROTOCOL VERSION DATE:
AMENDMENT NUMBER / UPDATE DATE:
CIRB EXPIRATION DATE:
NAME OF CIRB REVIEWER:
ROLE:

Chair

Vice Chair

Designated Reviewer

DATE COMPLETED:
REVIEWER CONFLICT OF INTEREST:
By checking this box, the reviewer confirms there are no conflicts of interest relative to this
study per the Conflict of Interest Policy for CIRB Members.

1.

The response is submitted in reference to CIRB-required modification(s) resulting from:
Initial Review by the CIRB
Amendment Review by the CIRB
Continuing Review by the CIRB
Recruitment Materials Review by the CIRB

Version 2, 11/20/2015

Other:
2.

Indicate the documents reviewed (check all that apply):
Required:
CIRB outcome letter listing CIRB-required modification
Study Chair Response Letter
Additional Documents:
CIRB meeting minutes (if applicable). Meeting date:
Updated NCI CIRB Application for Treatment Studies or NCI CIRB Application for
Ancillary Studies (not applicable for studies permanently closed to accrual)
Updated Summary of CIRB Application revisions (not applicable for studies permanently
closed to accrual)
Updated Summary of Changes/Change Memo (if response is related to an amendment)
Updated Study Protocol(s)
Updated Consent Form(s)
Other, please specify

3.

Does the response adequately address all modifications required by the CIRB?
Yes
No. If no, respond to the questions below:
a. Was a satisfactory justification provided for not addressing all modifications required
by the CIRB?
Yes
No. Indicate which modifications must be completed:

4.

Does the response include modifications in addition to those required by the CIRB?
Yes. If yes, respond to the questions below:
a. Are the additional modifications administrative/editorial in nature only?
Yes. Proceed to Question 5.
No. Proceed to b.
b. Describe how the changes are minor:
c. Do the changes negatively impact the risk/benefit ratio?
Yes. If yes, the response must be reviewed by the convened CIRB.
No.
No.

5.

Determination:
Approve
Approve Pending Modifications (provide rationale and required modifications in Question
6)
Forward for review by convened CIRB (provide rationale and a description for key
concerns for the CIRB to address in Question 6)

Version 2, 11/20/2015

Reviewer requests additional information before a determination can be made (provide
details on additional information required in Question 6)
6.

Comments:

Version 2, 11/20/2015