Site Addition Form

Attach_A04_siteadd
ttachA4i_SiteAdditions
_ Attachment_
"UUBDI@F@TJUFBEE

OMB#0925
OMB#
0
424
Expiration Date:
12/31/2013
Expiration
xxxxxxxxxxxx1/31/2017

OMB# 0925-0753
Expiration Date 07/31/2021

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,
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
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 suggestions
number. Send
comments
regarding
thisNIH,
burden
estimate
or anyBranch,
other aspect
of this collection
information,
including
for reducing
this
burden, to:
Project
Clearance
6705 Rockledge
Drive,ofMSC
7974,
including
suggestions
for
reducing
this
burden,
to:
NIHxxxx,
Project
Clearance
Branch,
6705
Rockledge
Drive,
Bethesda, MD 20892-7974, ATTN: PRA (OMB#0925-0753). Do not return the completed form to this address. MSC 7974,
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:
1. Select the hand tool.
2. Position the pointer inside a field, and click to type text.
3. After entering text or selecting a check box, do one of the following:
- Press tab to accept the form field change and go to the next form field.
- Press Shift+Tab to accept the form field change and go to the previous form
field.
- Press Enter (Windows) or Return (Mac OS) to accept the form field change and
deselect the current form field.
4. Once completed, print the form.

August_2011

Attach_A4_siteadd

OMB# 0925-0753
Expiration Date 07/31/2021

Cancer Trials Support Unit

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

Submit to the CTSU
Email, Mail or Fax to:
Regulatory Office via the
Cancer Trials Support Unit (CTSU)
Regulatory
ATTN: Coalition of Cancer Cooperative
GroupsSubmission
(CCCG)
Portal:
www.ctsu.org.
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:

)|

|-|

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

July_2018
Final_October_2016
Final_July2013
Authorized
by CTSU for local reproduction

Authorized for reproduction by CTSU a service of NCI

|