Form 4 Attach 1D - Optional Form 1 - Withdrawal from Protocol P

Attach_1d_WD Form

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

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including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data
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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,
including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974,
Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx). Do not return the completed form to this address.

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Cancer Trials Support Unit
Optional form 1
Withdraw from Protocol Participation

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

Institution Name (List all institutions covered by IRB approval that will

NCI Institution Code : (ALXXX)

conducted this study.)

Protocol Title: (Short version acceptable)

Protocol Number: (lead Group #)

Rationale for Study Closure: (Select the answer that best describes the closure.)
1) No subjects were accrued at the institution(s) listed above, and the
protocol is now closed to accrual by sponsoring organization.
2) No subjects were accrued at the institution(s) listed above, and the
study has been closed with the local IRB with no anticipation of future
accrual. (If the protocol is re-opened at a later date the site must submit
the CTSU IRB Certification form for an initial approval.)
3) All subjects accrued at local institutions have completed treatment,
and follow-up, and no further accruals are anticipated at the institution(s)
listed above.
4) IRB/Ethics board responsibilities for the protocol listed above are
being transferred to another IRB. Review responsibilities at IRB #
___________ are being transferred to IRB# ______________. (Please
(The IRB Signatory must sign below if
note that the CTSU IRB Certification form must be submitted for the
reason #4 is selected. or attach signed
initial review of all protocols under the new IRB. Submission of this
letter from IRB.)
form only documents withdraw of approval at the originating IRB.)

Date of IRB/Ethics Board Action: ___|____|_____
mm dd yyyy
The institutional staff signing below certifies that the information provided above is correct.
Name of Signatory:
Name of approving Organization:
Title of Signatory:

Phone
(_______) |________| - |__________|

Signature:

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

Final Oct_2010
Authorized for reproduction by CTSU a service of NCI