Form 2 IRB Certification

Attachment_A02_IRBCRT

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

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 (OMB#0925-xxxx). Do not return the completed form to this address.

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

Attach_A2_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

Cancer Trials Support Unit
INSTITUTIONAL REVIEW BOARD
CERTIFICATION

[email protected]
1) Protocol #:

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 this IRB approval
that will conduct the study. Add attachment for additional sites.)
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
FWA0000012

FWA Expiration Date (mm/dd/yyyy)
03/01/2015

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*

*Provide number from applicable category in box 11) __________
11) Commonly Used Expedited Review Categories
(Indicate selection in 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) Other Expedited Review Categories: If a different expedited review category is utilized under 45CFR46.100, provide the category or explanation
below.
13) Approval Period:
12) Date of IRB or Designee Review from box 10:
Effective:

/
/
mm dd yyyy
14) Was the protocol approved with contingencies? YES
Provide date all contingencies were
approved by the IRB or Designee:

/

NO

|
|
m m d d y y yy

Expiration:

/
/
m m d d y y yy

16) Comments:

/

mm dd yyyy
15) OHRP IRB Registration Number (8 digits long)
IRB#:
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 #22 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.
17) Name of IRB Signatory:
18) Name of approving IRB:

_____________________________________
19) Title of IRB Signatory:

20) Phone
(

_________________________________________
21) Signature:
_____________________________________________________________________________

Final_Jan_2014
Authorized by CTSU for
local reproduction
reproduction
by CTS

)|

|-|

22)
mm d d

y y y y

|

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.

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
Institution Number and Expiration Date
(mm/dd/yyyy)
Code

Ex. University of Texas

TX002

Final_Jan_2014
Authorized by CTSU for local reproduction

FWA00000123 09/02/2007