Form 28 CIRB AR Application

CIRB AMENDMENT REVIEW APPLICATION
Attachment_B12_AR_App

OMB# 0925-0753, Expiration Date: 07/31/2021

#0925-0753
Date:
06/30/2020
The purpose of the information collection is to conduct reviews of clinical OMB
trial studies.
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mandate
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completion
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information you provide will be combined for all participants and reported as summaries. It will be kept private to the extent provided
NOTIFICATION
TO RESPONDENT OF ESTIMATED BURDEN
by law.
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.NOTIFICATION
An agency may
not conduct or
andBURDEN
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time for
or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0753). Do not return the completed
the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
form to this address.
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

This application has been designed to meet the regulatory requirements for review, so
answer each question as completely as possible.
• All answers must be in lay language.
• If an answer to any question cannot be provided, provide an explanation for the
missing answer.
• If you have any questions regarding the completion of this application, contact the
CIRB Helpdesk at [email protected] or 888-657-3711.
STUDY ID:
STUDY TITLE:
PROTOCOL VERSION DATE:
Provide the protocol and consent form with this Protocol Version Date.
STUDY CHAIR
Name
Institution Name
Phone Number
Email
Administrative
Assistant Name
Administrative
Assistant E-mail
Administrative
Assistant Phone
Number
CONTACT PERSON (Person to contact with questions about this application)
July 2018

Version Date 07/26/17

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Name
Title
Institution Name
Phone Number
E-mail
1.0

Type of Submission
Amendment (complete Sections 2.0 and 3.0)
Are the changes in response to a CTEP Request for Rapid Amendment (RRA)?
Yes

No

Participant-Directed or Recruitment Material (complete Section 4.0)
2.0

Description of the Amendment
2.1

Provide a brief description of the changes:

2.2

Provide the rationale for the changes:

2.3

Are the changes minor? Minor changes do not impact the study design, scientific
intent, participant population or participant risk.
Yes

2.4

No

In the Study Chair’s view, do the changes impact the risks or benefits to study
participants? (Consider those participants already enrolled in the study, as well as
those who may enroll in the future if the study is open to accrual.)
Yes

No

Provide a brief explanation for this assessment:
2.5

Are the changes in the amendment in response to significant new findings?
Yes

No

Provide a brief summary of the significant new findings that resulted in the
amendment:
2.6

Are these changes potentially significant enough to impact a study participant’s
willingness to continue their participation in the study?
Yes

No

Provide a brief explanation for this assessment:
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2018
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Date 07/26/17

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3.0

Participant Notification
If the changes in the amendment are in response to significant new findings (per question
2.5) or could impact a study participant’s willingness to continue their participation in the
study (per question 2.6), participants must be notified of the changes or informed of the
findings.
At the Study Chair’s discretion, participant notification may be required even if the
changes are neither a result of significant new findings nor impact a study participant’s
willingness to continue their participation in the study.
Is participant notification required?
Yes

No

Indicate the reason below:
There are no participants enrolled.
Participants do not need to be notified as they are not in response to significant new
findings and do not impact a study participant’s willingness to continue in the
research.
Participants must be informed of the changes (complete the remainder of section 3
below)
3.1

Which study participants must be informed of the changes (e.g. all participants,
only participants who enroll going forward, only participants on intervention, only
a certain subset of participants, etc.)?

3.2

How will study participants be informed of the changes:
Participant-directed letter or memo;
Consent form addendum to be signed by participants;
Updated consent form to be signed by participants (re-consent);
Verbal notification with documentation in study participants’ research records
(provide the CIRB with information to be provided to PIs to facilitate verbal
notification).
Other:
NOTE: Material(s) directed to study participants, including the materials listed
above, whether developed by the Study Chair or participating PIs, must be
included in the submission and approved by the CIRB prior to distribution except
when necessary to eliminate apparent immediate hazards to study participants (per
45 CFR 46.103(b)(4) and 21 CFR 56.108(a)(4)).

3.3

When will study participants be informed of the changes? (E.g. as soon as
possible, at next study visit, etc.)

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2018
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4.0

Participant-Directed or Recruitment Material
4.1

Provide a brief description of the material being submitted:

4.1.1

4.2

If previously approved by the CIRB, provide a brief summary of the
changes being made and the reason for the changes:

Submission of material directed to study participants or potential study
participants requires a distribution plan. Provide a brief description of how and
when the submitted material will be distributed to study participants or potential
study participants:

Checklist of CIRB-Requested Supporting Documents
Protocol upon which this application is based (REQUIRED)
Consent form with the same Protocol Version Date as the protocol (REQUIRED)
Change Memo (REQUIRED)
Provide the following materials if applicable:
Participant-directed letter or memo
Consent form addendum to be signed by participants
Information to be provided to PIs to facilitate verbal notification of participants.
New/Updated recruitment material
Updated Investigator’s Brochure
New/Updated forms intended to be completed by study participants
New/Updated study-specific educational materials
Submit the completed application and the required supporting documents via email to
[email protected], [email protected], [email protected], or
[email protected] within 10 days of CTEP/DCP Approval-On-Hold date.

July
2018
Version
Date 07/26/17

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