Attachment 1b IRBCRT

Attach_1b_IRBCRT

OMB#0925-0624
OMB#
0925-0624
Expiration Date:12/31/2013
Expiration
Date 1/31/2017

Public reporting burden for this collection of information is estimated to average 10 minutes per response,
Public reporting
burden
for this
collection searching
of information
is estimated
to vary
from and
10 to
11minutes the
perdata
response,
including
the time for
reviewing
instructions,
existing
data sources,
gathering
maintaining
including
time for and
reviewing
instructions,
searching
existing data
sources,
gathering
and ormaintaining
the data
needed,
andthe
completing
reviewing
the collection
of information.
An agency
may
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sponsor, and
needed,isand
completing
and reviewing
the collection
of information.
agency amay
not conduct
or sponsor, and
a person
not required
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to, a collection
of information
unlessAn
it displays
currently
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a person
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collection
of information
it displays
a currently
valid OMB
control
number.
Send
comments
regardingto,
thisa burden
estimate
or any otherunless
aspect of
this collection
of information,
control suggestions
number. Send
comments
regarding
burden
estimate
or anyBranch,
other aspect
this collection
information,
including
for reducing
this
burden, this
to: NIH,
Project
Clearance
6705 of
Rockledge
Drive,ofMSC
7974,
Bethesda,
20892-7974,
ATTN: PRA
(OMB#0925-0624).
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form to thisDrive,
address.
includingMD
suggestions
for reducing
this burden,
to: NIH, Project
6705 Rockledge
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 1/31/2017

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 #:

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

6 & 6a) OHRP Federalwide Assurance Number

7) Principal Investigator:

8) NCI Investigator #:

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.
12) Date of IRB or Designee Review from box 10:
13) Approval Period:
/
mm

Effective:

/
dd

yyyy

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

YES

|
|
mm dd

Expiration:
y y yy

/
/
mmdd yyy

NO
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
July_2011
Authorized
by for
CTSU
for local reproduction
Authorized
reproduction
by CTSU a service of NCI

)|

|-|

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

Ex. University of Texas

TX002

Final_Jan_2014
Final
June_2009
Authorized by CTSU for local reproduction
Authorized for reproduction by CTSU a service of NCI

FWA00000123 09/02/2007