Form 34 CIRB Statistical Reviewer Form

Attachment 6J:

NCI CIRB
STATISTICAL REVIEWER FORM

OMB#: 0925 – xxxx Expiry Date: xx/xx/xxxx
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. While your participation is
completely voluntary, to participate in the NCI CIRB, completion of this form is required. Data
collected as part of the NCI CIRB review is private and protected by law. Under the provisions of
Section 301d of the Public Health Service Act, no information that could permit identification of a
participating individual may be released. All such information will be kept private under the
Privacy Act and will be presented only in statistical or summary form.

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.

Version 09/12/08

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NCI CIRB
STATISTICAL REVIEWER FORM
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 09/12/08

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