Form 4 Site Addition

Attach_A04_siteadd
ttachA4i_SiteAdditions
_ Attachment_
Attach_1e_siteadd

OMB#0925
OMB#
0

424

OMB#
0925-xxxx
Expiration
Date:
12/31/2013
OMB#
0925-0624
Expiration
xxxxxxxxxxxx1/31/2017
Expiration
Date:
xx/xx/xxxx
Expiration Date xx/xx/xxxx

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
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 amay
not conduct
or sponsor, and
a person
not required
to respond
to, a collection
of information
unlessAn
it displays
currently
valid OMB

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,

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,

includingMD
suggestions
for reducing
this burden,
to: NIHxxxx, Do
Project
Clearance
Branch, 6705
Drive, MSC 7974,
ethesda,
20892-7974,
ATTN: PRA
(OMB#0925-xxxx).
not return
the completed
formRockledge
to this address.

Bethesda, MD 20897974, ATTN: PRA (OMB#0920624). Do not return the completed form to this address.

Filling out PDF Forms

This PDF form contains “roll-over or double-click ” help functionality.

This form allows you to enter data directly onto the screen. After completing the form,
you are able to print the document so that you can fax/mail the document.

To fill out a form:
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deselect the current form field.

4. Once completed, print the form.

August_2011

Attach_A4_siteadd

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

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

[email protected]

This form can be utilized when an IRB has added an additional 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, an 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 #:

2) Protocol Title: (Shortened version acceptable)

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

3b) Parent Institution NCI Code 3c) Parent Institution FWA Assurance
Number:
(ALXXX):

4a) New Institution Name(s) (List the names of the new institutions
being added to the parent institution’s approval)

4b ) New Institution NCI
Code (ALXXX)

5) Principal Investigator:

6) NCI Investigator #:

4c) New Institution FWA Assurance
Number:

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
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:

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17) Date:
/_
/_
mm d d y y y y

Final_October_2016
Final_July2013
Authorized
by CTSU for local reproduction

Authorized for reproduction by CTSU a service of NCI

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