Form 13 TAILORx PACCT1_DTF

Attach_1u_TAILORx_PACCT1_DTF

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

Publicreporting burden for this collection of information is estimated to average 10 minutes per response, 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 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.

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.

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

CTSU Data Transmittal Form Instructions for
PACCT1

CTSU Data Transmittal Form Instructions for TAILORx/ PACCT-1

o

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o

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Complete
1 transmittal
for each
patient
protocol.
to
Be sure patient
ID andform
protocol
number
are and
present
on theBe
topsure
of each
include
your
contact
information
in
case
of
questions.
submitted page. If this is not done, you will be asked to resubmit.

o

BePlease
sure patient
protocol
number
are present
on the
top of each
removeID
alland
patient
identifiers
or HIPAA
protected
information.
submitted page. If this is not done, you will be asked to resubmit.

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All CRF’s, reports etc should be faxed to 301-545-0406.
-coded tran All su
CRF
All submitted documents must include athedata
new
bar-coded
transmittal
-coded All
tran
form.
dat
n transmittal
All s
All
CRF’s,
reports
etc
should
be
faxed
to
301-545-0406.
s
o
301-545
All
CR
s,Forms
reports
etc
should
be
faxed
to
301-545-0406.
form. Forms
Forms
will
not
be
processed
properly
if
the
transmittal
is not
transmittal
data
e
new
bar-coded
tran
form.
will notwil
be processed properly if the dat
n
form.
Fo
-545-0406.
-545
06.
included.
perly
d.
the if the transmittal
nsmittal
is
not d.
included.
All submitted
documents must include the new bar-coded transmittal
All submitte
form.
Formsforms
will not
be processed
properly
if thestudies
transmittal
not
Transmittal
are now
study specific
for certain
on theisCTSU
included.
menu. It is crucial to select the appropriate form for your study when
submitting documents.
Transmittal forms are now study specific for certain studies on the CTSU
menu.
It is 1crucial
to select
your study
whento
Complete
transmittal
form the
for appropriate
each patientform
and for
protocol.
Be sure
submitting
documents.
include your
contact information in case of questions.

o

Do not fax more than 50
2 pages in a single transmission. This may cause
Please
remove
all
patient
identifiers
or HIPAA
protected information.
the system to malfunction,
potentially
losing pages.
Do
faxto
more
than 50
pages
in a single
may
cause
Benot
sure
complete
the
transmittal
formtransmission.
in its entirety. This
If the
transmittal
the
system
to malfunction,
potentially
form
is not
complete and
correctlosing
for pages.
each submitted form(s), the

documents may be returned.
Be sure to complete the transmittal form in its entirety. If the transmittal
form
is check
not complete
and correct
form(s), sent.
the
o
Please
your fax machine
to befor
sureeach
faxessubmitted
were successfully
documents may be returned.
Refer to the PACCT-1 Instructions for Case Report Form Completion document for
additional
guidance
[CTSU
Websiteto->beProtocols
-> were
PACCT-1
-> LPO
Documents
o
Please
check your
fax machine
sure faxes
successfully
sent. -> ->
Documentsess
Case Report Forms].
o

Please contact CTSU Help Desk at 1-888-823-5923 if you have any
questions or have problems faxing

OMB# 0925-0624
Expiration Date xx/xx/xxxx

Attach_1u_TAILORx_PACCT1_DTF

TAILORx/ PACCT1
CTSU Data Transmittal Form (DTF)
Please FAX to: 1-301-545-0406
Contact the CTSU Help Desk regarding technical/ faxing issues (888) 823-5923
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

Record only one patient and Protocol ID per Data Transmittal Form (DTF).
Ensure Patient ID and Protocol ID are recorded on each page of each item submitted.
Ensure pages are in proper sequence; two-sided forms muct be copied by site prior to faxing.
20 pages in one submission.
DO NOT fax more than 50
DO NOT submit amended Case Report Forms (CRFs).
Complete a TAILORx Unsolicited Data Modification Form to update data on previously submitted forms or RDC-entered data.

Date: __ __ - __ __ - __ __ __ __
m m

d d

y

y

y

Patient ID: __ __ __ __ __

Total Pages Faxed: ______

y

(including transmittal)

Site Name: ______________________________________________________________ NCI Code: __ __ __ __ __
Site Address: ___________________________________________________________________________________
Completed By*: _____________________________________________

Phone #*: _________________________

Email Address*: _________________________________________________________________________________

*

The above contact information will be used if a data submission needs to be re-submitted with corrective action.

PLEASE NOTE: Sites submitting items improperly will be contacted to take corrective action and re-submit data.

CRFs/ Reports/
Documents
On Study Form
Chemotherapy Form

Submitted

# of
pages

____
____

Cross Registration Form

____

____

Pre-Registration Form

____

Radiology Report
Lab Report
Mammogram Report
CTSU Data Clarification
Form (DCF)
CTSU Unsolicited Data
Modification Form (UDM)

FUP

Sec Primary

Non Prot TX

Recurrence

Death

____

Second Primary Form

Surgical Report

End TX

____

Follow Up Form

TAILORx Material
Submission Form
TAILORx Source Document
Tracking Coversheet (SDT)
Path Report with/ without
ERPR/Her2 reports
ERPR Report or
Her2/neu Report
Physician Note

Baseline

____

Radiation Therapy Form

Non-Protocol Therapy Form

Visit

____
____
____
____
____
____
____
____
____

Revised 01/19/2015
03/12/2015