14a Study Review Responsibility Transfer Form

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

ο

Form 2M: Study Review Responsibility Transfer 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
“Step 2 is to confirm the information and
submit”

Text added
“confirm the information, and submit.”
“Step 2 is the CIRB completion of the
transfer”

“Next”

“Confirm”

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
[email protected]

Page 1 of 1

Study Review Responsibility Transfer Form

Page 1 of 2

Study Review Responsibility Transfer 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 Study Review Responsibility Transfer Form indicates that the CIRB is
no longer the IRB responsible for review of this study. This is a two-step process. Step
1 is to complete this form, confirm the information, and submit. Step 2 is the CIRB
completion of the transfer.
Step 1: Complete this form.
Click “Confirm” once the form is completed and you will be taken to the confirmation page.
Note: If you wish to transfer more than one study, a separate request must be made for each study
being transferred.
Fields marked with * are required.
*Study Number: Select from the List
Study Title:
*Name of Local IRB: Select from the List
Institution’s FWA Number:FWA00005287
Local IRB Registration Number:
c Click this box if there are study participants enrolled at a site covered by this IRB.If so,upload a copy of the
d
e
f
g
IRB approval letter. NOTE: Your IRB must have approved the study via local procedures before transfer so there
is no lapse in IRB oversight of the study.
*Upload IRB Approval Letter:

Browse...

c Click this box if there are no study participants enrolled at a site covered by this IRB. NOTE: Proof that the
d
e
f
g
study is open is not required since there are no participants enrolled.

Confirm
If you wish to return to the Facilitated Review (FR) Submission Report, click the "Go Back" button
(all information entered will be lost). Go Back
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 [email protected]

http://www.ncicirb.org/members/SiteTransfers.asp

3/10/2011

Study Review Responsibility Transfer Form

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User Number: 370486
back to top

http://www.ncicirb.org/members/SiteTransfers.asp

3/10/2011

Study Review Responsibility Transfer Form (draft 07/20/10)

page 1

Study Review Responsibility Transfer 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 (0925-0625*). Do not return the completed form to this address.

Submission of this Study Review Responsibility Transfer Form indicates that the CIRB is
no longer the IRB responsible for review of this study. This is a two-step process. Step
1 is to complete this form. Step 2 is to confirm the information and submit.

Step 1: Complete this form.
A: Click “Next” once the form is completed and you will be taken to the confirmation page.
Note: If you wish to transfer more than one study, a separate request must be made for each study
being transferred.
Fields marked with * are required.
*Study Number:

Select from the List

Study Title:

*Name of Local IRB:

Select from the List

*Institution’s FWA Number Auto-populate
*Local IRB Registration Number Auto-populate
Click this box if there are study participants enrolled at a site covered by this IRB. If so,
upload a copy of the IRB approval letter. NOTE: Your IRB must have approved the study via
local procedures before transfer so there is no lapse in IRB oversight of the study.
*Upload IRB Approval Letter:
Click this box if there are no study participants enrolled at a site covered by this IRB.
NOTE: Proof that the study is open is not required since there are no participants enrolled.
If you have any questions, call the NCI CIRB Helpdesk at 888-657-3711 or email
[email protected].

Study Review Responsibility Transfer Form (draft 07/20/10)

page 2

NEXT BUTTON
If you wish to return to the Facilitated Review Submission Report, click the ‘Go Back” button (all information
entered will be lost). GO BACK BUTTON

Study Review Responsibility Transfer Form (draft 07/20/10)

page 3

Step 2 – Confirmation and Submission
Step 2: Review information on this confirmation page and click “Submit” if information is correct.
If changes are required, click “Go Back” and you will be returned to the Study Review
Responsibility Transfer Form where you may make changes.
A: Once you click “Submit”, your browser will automatically take you back to the
Facilitated Review (FR) Submission Report webpage.
B: You will receive an email from the CIRB Operations Office confirming receipt of your
transfer request.

Study Number: CALGB-80303

Study Title: "A Randomized Phase III Trial of Gemcitabine Plus Bevacizumab (NSC
#704865 IND# 7921) versus Gemcitabine Plus Placebo in Patients with Advanced Pancreatic
Cancer"

Name of IRB: Missouri Baptist Medical Center
Institution’s FWA Number: FWA00001234
Local IRB Registration Number: IRB00001234
Study participants are enrolled at a site covered by this IRB.
OR
Study participants are not enrolled at a site covered by this IRB.
IRB Approval Letter, if applicable : C:\Documents and
Settings\lcovington\Desktop\transcript.doc OR Not applicable
After your review, select the appropriate option below:
If you want to change any information, click on “Go Back”. [‘Go Back’ Button]
OR
If the information is correct, click the Submit button. You will receive an email
acknowledgement of the submission.
[‘Submit’ Button]