Form 48 Current CIRB Stat Reviewer Worksheet

NCI CIRB
REVIEWER WORKSHEET
Statistical Reviewer Form

Attachment_B32_Stat_Rev

OMB#0925-0753 Expiration Date: 06/30/2020

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 15 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. From the statistical perspective, briefly explain how the risks to subjects are minimized per 45. CFR
46.111(a)(1), “by using procedures which are consistent with sound research design and which do not
unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already
being performed on the subjects for diagnostic or treatment purposes.”
As you respond, you may want to consider these points:
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The primary clinical objective(s) and the corresponding primary statistical hypothesis
Whether the statistical hypothesis properly addresses its clinical counterpart
Whether the plans for data analysis, including the decision rule, type I and II error rates, are
clearly defined
Whether an appropriate group sequential design, with both efficacy and futility bounds is
employed

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If this is a non-inferiority (or equivalence) trial, what the margin of non-inferiority (or
equivalence) in terms of an odds-ratio (for binary outcomes) or hazard-ratio (for time-toevent outcomes) is

Note: If you wish, you may contact the Group statistician for additional information prior to the CIRB meeting.
Reviewer Comments: