Form 5 Site Addition Form

Attach_1di_SiteAdditions
Attachment_1e_siteadd

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

Public reporting burden for this collection of information is estimated to average 5 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
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
needed,is and
completing
and reviewing
the collection
of information.
agency may
not conduct
or sponsor, and
a person
not required
to respond
to, a collection
of information
unlessAn
it displays
a currently
valid OMB
a person
is not
required
to respond
collection
of information
a currently
valid OMB
control
number.
Send
comments
regardingto,
thisa burden
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
6705of
Rockledge
Drive,
7974,
includingMD
suggestions
for reducing
this burden,
to: NIH, Project
6705 Rockledge
Drive,
MSC 7974,
Bethesda,
20892-7974,
ATTN: PRA
(OMB#0925-0624).
DoClearance
not return Branch,
the completed
form to this
address.
Bethesda, MD 20892-7974, ATTN: PRA (OMB#0925-0624). Do not return the completed form to this address.

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August_2011

Cancer Trials Support Unit

Site Addition Form
(Utilized for the addition of a site to an existing IRB approval)

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
CTSURegulatory@ctsu.coccg.org

This form can be utilized when an IRB has added an affiliate site to an existing IRB approval.
 This form can be submitted in lieu of an IRB approval letter if signed by an IRB signatory.
 If not signed by an IRB signatory, the IRB approval letter must accompany this form.
 If the approval applies to multiple protocols, attach a supplemental list of protocols to this form.
1) Protocol # (Lead Group#):

2) Protocol Title: (short form acceptable):

3a) Parent Institution Name (List the name of parent institution who
has the current IRB approval):

3b) Parent NCI Institution
Code (ALXXX):

3c) Parent FWA Assurance Number:

4a) Affiliate Institution Name(s) (List name of affiliate institution(s)
that are being added to the parent institution approval.)

4b ) Affiliate NCI Institution
Code (ALXXX)

4c) Affiliate FWA Assurance Number:

5) Principal Investigator:

6) NCI Investigator #:

This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations or
subparts:
7) Approval Type:
8) Review Type:
Initial or Renewal

Amendment

9) Date of IRB or Designee Review in box 7:
/
mm

Full Board

Expedited

10) OHRP IRB Registration Number:

/
dd

IRB

yyyy

11) 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 #17 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.
12) Name of IRB Signatory:
13) Name of approving IRB:

14) Title of IRB Signatory:

15) Phone
(_______) |________| - |____________|

16) Signature:

17) Date:
_____/______/_________
mm d d y y y y

Final_July2013
Authorized for reproduction by CTSU a service of NCI