Form 4 Site Addition

Attachment_A04_Site Addition

OMB# 0925•0753
Expiration Date 07/31/2021

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Attachment_A04_Site Addition

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

Cancer Trials Support Unit
Site Addition Form

(Utilized for the addition of a site to an existing IRB approval)

Submit to the CTSU Regulatory Office via the
Regulatory Submission Portal: www.ctsu.org.

This form can be utilized when an IRB has added an additional site to an existing IRB approval.
• This form can be submitted in lieu of an IRB approval letter if signed by an IRBsignatory.
• If not signed by an IRB signatory, an IRB approval letter must accompany this form.

•

If the approval applies to multiple protocols, attach a supplemental list of protocols to this form.

1) Protocol #:

2) Protocol Title: (Shortened version acceptable)

3a) Parent Institution Name (List the name of the parent
institution who has the current IRB approval):

3b) Parent Institution NCI Code (ALXXX):

4a) New Institution Name(s) (List the names of the new
institutions being added to the parent institution’s
approval)

4b ) New Institution NCI Code (ALXXX)

5) Principal Investigator:

6) NCI Investigator #:

This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations
or subparts:
7) Approval Type:
8) Review Type:
Initial or Renewal ☐ Amendment ☐
Full Board ☐ Expedited ☐
9) Date of IRB or Designee Review in box 7:
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10) OHRP IRB Registration Number:

yyyy

11) Comments:
The official signing below certifies that the information provided above is correct and that, as required, future reviews will be
performed & certification will be provided. Questions #1 through #17 must be completed for this form to be accepted.
Check here if this form is an IRB signatory as documented on the institutional assurance with OHRP ☐.
13) Name of approving IRB:
12) Name of IRB Signatory:
14) Title of IRB Signatory:

15) Phone

16) Signature:

17) Date:

Final_July_2018
_ by CTSU for local reproduction
Authorized

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