13a Facilitated Review Acceptance Form (FRAF)

NCI CIRB OMB Nonsubstantive Change Request
OMB #: 0925-0625
Expiry Date: 1/31/2014

ο

Form 2L: Facilitated Review Acceptance Form
The instructions on this website form were revised to be more clear and easier to
understand for the public. No additional burden to the public is foreseen.

Text deleted
“indicated below and is requesting the
CIRB to be”

“submit it electronically by clicking on the
‘Submit’ button at the bottom

“Institution IRB Name”
“Local IRB Chair Name”
“Local IRB Contact Email”
“Local IRB Contact Name”
“Additional recipient of this
acknowledgement Email”
“I confirm that all the information provided
is correct”
Our institution has reviewed and accepts
the responsibilities outlined in the
“Division of Responsibilities” between the
Central IRB and Participating Local
Institutions” handout”

Text added
“Submission of this Facilitated Review Acceptance
Form (FRAF) is mandatory to indicate to the CIRB
that your IRB has conducted a facilitated review for
this study. Once the CIRB Operations Office
confirms receipt of this FRAF, the CIRB is the IRB
responsible for review of the study”
Step 1. Complete this form
Step 2. Click “Next” once form is completed…
Step 3. Review information on confirmation
page…
Step 4. Once you click “Submit,” your browser will
automatically take you back to the main page…
Step 5. You, and everyone whose email you
include on this form, will receive…
Important Note: a separate FRAF must be
submitted for every study when facilitated review
is conducted.
“Name of Local IRB”
Name of Person Submitting the FRAF
Email for Person Submitting the FRAF

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CIRB Facilitated Review Acceptance Form

Page 1 of 2

Facilitated Review Acceptance Form
OMB#: 0925 – 0625

Expiry Date: 01/31/2014

STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. Your participation is completely voluntary. You are subject to no penalty if you choose not to provide all or any
part of the requested information. Data collected as part of the NCI CIRB review is confidential 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 held in confidence 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 10 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 (0925-0625*). Do not return the completed form to this address.

Submission of this Facilitated Review Acceptance Form (FRAF) is mandatory to indicate to the CIRB that your
IRB has conducted a facilitated review for this study. Once the CIRB Operations Office confirms receipt of this
FRAF, the CIRB is the IRB responsible for review of the study.
Step 1: Complete this form.
Step 2: Click “Next” once the form is completed and you will be taken to a confirmation page.
Step 3: Review information on the confirmation page and click “Submit” if information is correct.
If changes are required, click “Go Back” and you will be returned to this form.
Step 4: Once you click “Submit”, your browser will automatically take you back to the main page
of the Participant’s Area of the CIRB website.
Step 5: You, and everyone whose email you include on this form, will receive an email from the
CIRB Operations Office confirming receipt of the FRAF.
Important Note: A separate FRAF must be submitted for every study when a facilitated review is
conducted.

Study ID: COG-ARST0531

Randomized Study of Vincristine, Dactinomycin and
Cyclophosphamide (VAC) versus VAC Alternating with
Study Title: Vincristine and Irinotecan (VI) for Patients with
Intermediate-Risk Rhabdomyosarcoma (RMS): A Groupwide Phase
Name of Local IRB: Select from the List
Local IRB Registration
Number:
Institution’s FWA Number: FWA00005287
Name of Person
Michelle Stickler
Submitting the FRAF:

http://www.ncicirb.org/members/ProtocolAcceptance.asp?ID=24537&num=COG%2DAR... 3/10/2011

CIRB Facilitated Review Acceptance Form

Page 2 of 2

Email for Person
mcstickler@vcu.edu
Submitting the FRAF:
Enter email addresses of additional people to receive the confirmation email. Use
a semicolon (;) to separate email addresses.

Our IRB has performed a facilitated review of study COG-ARST0531 and requests the CIRB to be the IRB
responsible for review of this study.
Please check ONE of the following options:

j This is the first time COG-ARST0531 will be opened at our institution.
k
l
m
n
OR

n COG-ARST0531 was previously opened through our local IRB however by
j
k
l
m
submitting this form we are indicating that we want to transfer this study so
the CIRB will be the IRB responsible for review. Once we receive the
confirmation email that the Facilitated Review Acceptance Form has been
received by the CIRB Operations Office, we will document the transfer of
this study to the CIRB in our regulatory file.

Date FRAF Submitted to CIRB: 3/10/2011
If you have any questions or are having any difficulty completing this form, please call the NCI CIRB
Helpdesk at 888-657-3711 or email ncicirbcontact@emmes.com.

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User Number: 370486
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http://www.ncicirb.org/members/ProtocolAcceptance.asp?ID=24537&num=COG%2DAR... 3/10/2011

Facilitated Review Acceptance Form
OMB#: 0925 – 0625

Expiry Date: 1/31/2014

STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. Your participation is completely voluntary. You are subject to
no penalty if you choose not to provide all or any part of the requested information. Data collected as part of the NCI CIRB
review is confidential 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 held in
confidence 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 10 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-xxxx*). Do not
return the completed form to this address.