Form 11 Data Clarification Form

Attachment_1k_dcf
Attach_1m_DCF

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

Public reporting burden for this collection of information is estimated to average 20 minutes per response,
Public reporting
burden
for this
collection searching
of information
is estimated
to vary
from 15
20 minutesthe
per
response,
including
the time for
reviewing
instructions,
existing
data sources,
gathering
andtomaintaining
data
including
time for and
reviewing
instructions,
searching
existing data
sources,
gathering
and or
maintaining
the data
needed,
and the
completing
reviewing
the collection
of information.
An agency
may
not conduct
sponsor, and
needed,
completing
and reviewing
the collection
of information.
agency amay
not conduct
or sponsor, and
a person
is and
not required
to respond
to, a collection
of information
unlessAn
it displays
currently
valid OMB
a person
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to respond
collection
of information
a currently
valid OMB
control
number.
Send
comments
regardingto,
thisa burden
estimate
or any otherunless
aspect it
of displays
this collection
of information,
control suggestions
number. Send
comments
regarding
burden
estimate
or anyBranch,
other aspect
this collection
of MSC
information,
including
for reducing
this
burden, this
to: NIH,
Project
Clearance
6705 of
Rockledge
Drive,
7974,
Bethesda,
20892-7974,
ATTN: PRA
(0925-0624).
DoProject
not return
the completed
this address.
includingMD
suggestions
for reducing
this burden,
to: NIH,
Clearance
Branch, form
6705 to
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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OMB#0925-xxxx
OMB#0925-0624
Expiration Date: xx/xx/xxxx
Expiration
Date: 12/31/2013

Attachment_1k_dcf
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."