Form 2 Attach 1B - CTSU IRB Certification Form v. 2_July 2011

Attach_1b_IRBCRT

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

Attach_1b_IRBCRT

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]

Cancer Trials Support Unit
INSTITUTIONAL REVIEW BOARD
CERTIFICATION
1) Protocol #: (Lead Group #)

2) Protocol Version Date (Required for Amendments):
_____/_____/__________
m m d d y y y y

3) Protocol Title:
4) Institution Name (List all institutions covered by IRB approval that
will conduct this study. Attach complete list if necessary.)
Indicate # sites on supplemental sheet if applicable: ____
Ex: University of State

5) NCI
Institution
Code
ALXXX

6 & 6a) OHRP Federalwide Assurance Number

7) Principal Investigator:

8) NCI Investigator #:

FWA
FWA00000123

FWA Expiration Date (mm/dd/yyyy)
03/01/2006

This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations or subparts:
9) Approval Type:
Original

10) Review Type:
Amendment

Renewal

Full Board

Expedited*

Facilitated

*Provide number from applicable category in box 11)
11) Expedited Review Categories (Pick only one for box #10):
(45CFR46.110.8a-c: Continuing review of research previously approved by a convened IRB)
8.a Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related
interventions; and (iii) the research remains active only for long-term follow-up of subjects
8.b Where no subjects have been enrolled and no additional risks have been identified
8.c Where the remaining research activities are limited to data analysis
11a) Expedited Review (Other) If any other expeditable review category is utilized as the review type, please provide an explanation below:
___________________________________________________________________________________________________________
12) Date of IRB or Designee Review from box 10:
/
mm

dd

/

13) Approval Period:
Effective:

yyyy

14) Was the protocol approved with contingencies?
Provide date all contingencies were
approved by the IRB or Designee:

/

YES

NO

/

mm dd yyyy

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

|
|
mm dd
y y yy

Expiration:

/
/
mmdd yyy

15) NCI CIRB Review
(check if NCI CIRB review)
Give date of the initial facilitated
review by the local IRB or Designee:
/
/
mm dd yyyy
17) 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.
18) Name of IRB Signatory:
19) Name of approving IRB:
20) Title of IRB Signatory:

21) Phone

22) Signature:

23) Date:

July_2011
Authorized for reproduction by CTSU a service of NCI

(_______) |________| - |____________|
_____/______/_________
mm d d y y y y