Form 38 CPC FB Pharma Reviewer Worksheet

NCI Cancer Prevention and Control CIRB

REVIEWER WORKSHEET
Pharmacist Review of Cooperative Group Study

OMB #0925-xxxx Expiration Date: xx/xx/xxxx
Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation
in the NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or
withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information collected
will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB.
Information provided will be combined for all participants and reported as summaries. You are being requested to complete this
instrument so that we can conduct activities involved with the operations of NCI CIRB Initiative.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 2 hours 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.

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

1.

Are the background assumptions that led to use of the study drug(s) valid?
Yes, describe how:
No, explain why:

2.

Is the intervention designed to minimize risks to study participants?
(Consider as appropriate: dosage, supportive care, administration and
instructions if self-administered)
Yes, describe how:
No, explain why:

3.

Are the inclusion/exclusion criteria appropriate for the intervention?
Yes, describe how:
No, explain why:

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4.

Has an Investigator’s Brochure been provided for each investigational
agent used in the study?
Yes
No, (If no, the CIRB Operations Office will obtain it. Please provide agent
name to staff.)
Not Applicable

5.

Comments related to Question 4, if any:

6.

Is the pharmaceutical information provided in the protocol current and
accurate? (Including, but not limited to; preparation, administration,
contraindications, warnings, drug/food interactions, storage, instructions if selfadministered, etc.)

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Yes, describe how:
No, explain why:
7.

Is the dose modification section appropriate and clearly written?
Yes, describe how:
No, explain why:

8.

Will information be provided to study participants pertaining to drug/food
interactions and/or instructions for self-administration for any protocolspecific interventions?
Yes, describe how:
No (indicate what information the Study Chair should be requested to provide)
Not Applicable

9.

Comments related to Question 8, if any:

10.

Does the informed consent document accurately describe the study
intervention?
Yes
No, explain why:

11.

Comments related to Question 10, if any:

12.

Does the informed consent document include the reasonably foreseeable
risks related to the intervention?
Yes
No, explain why:

13.

Comments related to Question 12, if any:

14.

Is the frequency of risks related to the intervention categorized
appropriately? (likely, less likely or rare but serious)
Yes
No, explain why:

15.

Comments related to Question 14, if any:

16.

Additional Comments:

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