Form 13 Attach 1M - Data Clarification Form

Attach_1m_DCF

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
needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and
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control number. Send comments regarding this burden estimate or any other aspect of this collection of information,
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OMB#0925-xxxx
Expiration Date: xx/xx/xxxx

Attach_1m_DCF

PACCT-1
Data Clarification Form
Chen, Everett H.

Date:

Investigator: Chen, Everett H.

Patient #:

To:

DCF ID #:

Site:

12109

Reviewer:

Kim Yuen

Document #:

115248344

DCF Print Status: CREATED

7586223

Form Name

Visit Name

On Study Form 307

BASELINE

93462323

10-DEC-2007

Resolution

Comments
Page 1 of 2, Surgical Procedures: The
value provided for "Was axillary
dissection performed?" is
"ILLEGIBLE". Please review and
clarify.
PLEASE NOTE:
* DO NOT SUBMIT AN AMENDED
CASE REPORT FORM.
* SPECIFY THE CORRECT DATA
VALUE IN THE RESOLUTION BOX OF
THIS DATA CLARIFICATION FORM.
*** SUBMITTING "AMENDED CRF"
WILL RESULT IN A RE-QUERY FROM
CTSU ***

CRA Signature:_____________________________________
Date:_____________________

CTSU USE ONLY:
DRA CLOSED:

DATE:

Investigator Signature (required only if requested in the
Comments above):_________________________________
Date:_____________________
Page:

1

of

1

"Instructions: Please
Along with
a CTSU
Data
Form, always
return
the original by
signed
and dated
DCFData
to CTSU
(unlessForm.
it specifically
statesresponses
that a reply
not required).
Please
"Instructions:
return
this DCF
toTransmittal
the CTSU, signed,
dated and
accompanied
a completed
CTSU
Transmittal
Resolutions/
to is
Comments
should
be clearly
do
not
fax.
An
amended
form/page
is
not
required
(unless
requested
in
the
Comments
section
or
the
investigator
signature
was
omitted).
Please
provide
answers
to
Comments
specified in the above Resolution section. Values and units should be specified precisely in the same format as required on the case report form. Any changes made to this DCF should be
(queries)
directly
this DCF
in the
Resolution
section.
sureDCF
values
units arerecord."
reported precisely in the format shown on the Case Report Form. Initial and date all
initialed
and
dated.onPlease
retain
a copy
of the signed
andBe
dated
forand
the patient's
corrections to this DCF. Please retain a copy of this signed and dated DCF for patient records. If submitting a report, include the Patient ID and Protocol Number on EACH page of
the report. Thank You."