Form 5 Attach 1Di_Site Addition Form

Attach_1di_SiteAdditions

OMB#0925-0624
Expiration Date: 12/31/2013

Public reporting burden for this collection of information is estimated to vary from 10 to 11minutes 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 (OMB#0925-0624). Do not return the completed form to this address.

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August_2011

OMB#0925-0624
Expiration Date: 12/31/2013

Attach_1di_SiteAdditions

Cancer Trials Support Unit

Site Addition Form

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

Email, Mail or Fax to:
Cancer Trials Support Unit (CTSU)
ATTN: Coalition of Cancer Cooperative Groups (CCCG)
Suite1100
1818 Market Street
Philadelphia, PA 19103
FAX: 1- 215 - 569 - 0206

[email protected]

This form can be utilized when an IRB has added an affiliate site to an existing IRB approval.
This form can be submitted in lieu of an IRB approval letter if signed by an IRB signatory.
If not signed by an IRB signatory, the 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 #: (Lead Group #)

2) Protocol Title: (Short version acceptable)

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

3b ) Parent NCI Institution Code: (ALXXX)

4a) Affiliate Institution Name(s) (List name of affiliate institution(s) that are being added to the
parent institution approval.)

4b ) Affiliate NCI Institution 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

9) Date of IRB or Designee Review in box 10:
/
mm

Full Board

10) OHRP IRB Registration Number (8 digits long):

/
dd

Expedited

IRB

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 #20 must be completed for this form to be accepted.
Check here if the person signing this form is an IRB signatory as documented on the institutional assurance with OHRP.
12) Name of IRB Signatory:

13) Name of approving IRB:

14) Title of IRB Signatory:

15) Phone
(_______) |________| - |____________|

16) Signature:

17) Date:
_____/______/_________
mm d d y y y y

August_2011
Authorized for reproduction by CTSU a service of NCI