Form 2 CTSU IRB Certification Form

Attach_1b_IRBCRT

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

Public reporting burden for this collection of information is estimated to average 10 minutes per response,
Public reporting
burden
for this
collection of
information
is estimated
to vary
from 10
11minutes the
per data
response,
including
the time for
reviewing
instructions,
searching
existing
data sources,
gathering
andtomaintaining
including
time for and
reviewing
instructions,
searching
existing data
sources,
gathering
and or
maintaining
the data
needed,
andthe
completing
reviewing
the collection
of information.
An agency
may
not conduct
sponsor, and
needed,isand
and reviewing
the collection
of information.
agency may
not conduct
or sponsor, and
a person
not completing
required to respond
to, a collection
of information
unlessAn
it displays
a currently
valid OMB
a person
is not
required
to respond
a burden
collection
of information
a currently
valid OMB
control
number.
Send
comments
regardingto,
this
estimate
or any otherunless
aspect itofdisplays
this collection
of information,
control suggestions
number. Send
comments
regarding
burden
estimate
or any Branch,
other aspect
this collection
of MSC
information,
including
for reducing
this
burden, this
to: NIH,
Project
Clearance
6705ofRockledge
Drive,
7974,
Bethesda,
20892-7974,
ATTN: PRA
(OMB#0925-0624).
DoClearance
not returnBranch,
the completed
form to this
address.
includingMD
suggestions
for reducing
this burden,
to: NIH, Project
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

Cancer Trials Support Unit
INSTITUTIONAL REVIEW BOARD
CERTIFICATION

CTSURegulatory@ctsu.coccg.org
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

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
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.

CTSURegulatory@ctsu.coccg.org

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