Form 2 Attach 1B - CTSU IRB Certification Form

Attach_1b_IRBCRT

OMB#0925-xxxx
Expiration Date: xx/xx/xxxx

Public reporting burden for this collection of information is estimated at 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.

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OMB#0925-xxxx
Expiration Date: xx/xx/xxxx

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]
2) Protocol Version Date (Required for Amendments):
_____/_____/__________
mm dd
yyyy

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

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

7) Principal Investigator:

8) NCI Investigator #:

6 & 6a) OHRP Federalwide Assurance Number
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:
10) Review Type:

9) Approval Type:
Original

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 Meeting:

13) Approval Period:

/
mm

Effective:
/
/
m m d d y y yy

/
dd

yyyy

14) Was the protocol approved with contingencies?
Date all contingencies were met:

/

YES

NO

/

mm dd yyyy
16) OHRP IRB Registration Number:
IRB

Expiration: /
/
m m d d yy y y

15) NCI CIRB Review
(check if NCI CIRB review)
Give date if this is an initial facilitated review
/
/
mm d d
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:
_____/______/_________
mm d d y y y y
Final_June2009
Authorized for reproduction by CTSU a service of NCI

Attach_1b_IRBCRT

Cancer Trials Support Unit
INSTITUTIONAL REVIEW
BOARD
CERTIFICATION
Supplemental Page
Optional page for listing additional sites approved by
the local IRB. Please indicate on certification form the
number of sites listed on the supplemental form.

OMB#0925-xxxx
Expiration Date: xx/xx/xxxx

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]

In Reference to Protocol #:
Additional Institution Names (List all
additional institutions covered by IRB
approval that will conduct this study.)

OHRP Federal Wide Assurance
NCI
Number and Expiration Date
Institution
(mm/dd/yyyy)
Code

Ex. University of Texas

TX002

Final June_2009
Authorized for reproduction by CTSU a service of NCI

FWA00000123 09/02/2007