Form 12 Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form

Attach_1l_TAILORx_PACCT1_DTF

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

Public reporting burden for this collection of information is estimated to vary from 5 to 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

Attach_1l_TAILORx_PACCT1_DTF

CTSU Data Transmittal Form Instructions for
PACCT1

o

All CRF’s, reports etc should be faxed to 301-545-0406.

o

All submitted documents must include the new bar-coded transmittal
form. Forms will not be processed properly if the transmittal is not
included.

o

Transmittal forms are now study specific for certain studies on the CTSU
menu. It is crucial to select the appropriate form for your study when
submitting documents.

o

Complete 1 transmittal form for each patient and protocol. Be sure to
include your contact information in case of questions.

o

Be sure patient ID and protocol number are present on the top of each
submitted page. If this is not done, you will be asked to resubmit.

o

Please remove all patient identifiers or HIPAA protected information.

o

Do not fax more than 50 pages in a single transmission. This may cause
the system to malfunction, potentially losing pages.

o

Be sure to complete the transmittal form in its entirety. If the transmittal
form is not complete and correct for each submitted form(s), the
documents may be returned.

o

Please check your fax machine to be sure faxes were successfully sent.

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

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

Attach_1l_TAILORx_PACCT1_DTF

*STY-PACCT1*
TAILORx/ PACCT1
CTSU DATA TRANSMITTAL FORM
Please FAX to: 1-301-545-0406
Call 1-888-823-5923 if you are experiencing difficulty faxing
•
•
•
•
•
•

Record only one patient and protocol per transmittal sheet.
Ensure Patient ID and Protocol ID are recorded on each page of each item included.
Ensure pages are in proper sequence (2-sided forms must be copied by site before faxing).
Do not fax more than 50 pages in one submission.
Do not submit amended forms.
Complete a TAILORx Unsolicited Data Modification Form to update data on previously submitted forms.

Date: __ __-__ __ __-__ __ __ __
(dd-mmm-yyyy)

Total # Pages Faxed: _______

Patient ID#: __ __ __ __ __

(including transmittal)

Site Name: ________________________________________________________

NCI Site Code: __ __ __ __ __
(Example TX001)

Site Address: _________________________________________________________________________________
Completed By: ___________________________________________ Phone # ____________________________
Email address: _______________________________________________________________________________
Contact Information. Will be used if CTSU has questions or if data submission needs to be re-submitted with corrective action.

Provide the following forms directly to ECOG for the “Baseline”, “3 Months”, “6 Months”, “12 Months”, “24 Months”,
and “36 Months” reporting periods: Form 3112: TAILORx Assessment Compliance Form, Form 3113: TAILORx FACTCognitive Function Form, Form 3114: TAILORx FACT-Endocrine Systems Form, Form 3115: TAILORx FACT-Fatigue Scale
Form, Form 3116: TAILORx FACT-General Form, Form 3117: TAILORx PROMS Fatigue Short Form, Form 3118:
TAILORx Assessment of Survivor Concerns Form.
Provide the following form directly to ECOG as appropriate: Form 3018: ECOG Withdrawal of Consent.