Form 48 reviewer Worksheet CIRB Stat

NCI CIRB
REVIEWER WORKSHEET
Statistical Reviewer Form

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 1 hour per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
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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. 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
If this is a non-inferiority (or equivalence) trial, what the margin of noninferiority (or equivalence) in terms of an odds-ratio (for binary outcomes) or
hazard-ratio (for time-to-event outcomes) is

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

Version 02/10/14

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