Form 10 Attach 1J - N0147 CTSU Data Transmittal Form

Attach_1j_N0147DTF

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.

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

Attach_1j_N0147DTF

*STY-N0147*

N0147 CTSU DATA TRANSMITTAL FORM
For Post-Enrollment Data Submissions
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Use this form for post-enrollment data submissions; do not use this form to submit site registration/patient enrollment documentation
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
Amended forms are no longer accepted on the N0147 study and will not be processed.
For data changes initiated by a site to previously submitted CRFs, use the Site Initiated Data Update Form.

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

Total # Pages Faxed: _______

(dd-mon-yyyy)

Patient ID#: __ __ __ __ __ __ __

(including transmittal)

Site Name: ________________________________________________________

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

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

The item(s) listed below should be faxed to CTSU at 1-301-545-0406.
Call 1-888-823-5923 if experiencing difficulty faxing.
Do not mail forms that have been faxed.
(If absolutely needed, mailing address for data is at the bottom of this form)

DO NOT SUBMIT AMENDED FORMS.
Item(s) Attached

Colorectal Cancer - Adjuvant On-Study Form
Colorectal Cancer – Specimen Submission Form – Blood
Colonoscopy Report and Colonoscopy Report Cover Sheet
Pathology Report and Pathology Report Cover Sheet
Operative Report and Operative Report Cover Sheet

Number of
Pages

Visit

Baseline

Note: Send the Pathology Submission Form directly to NCCTG.

Colorectal Cancer -Treatment Form - Subset of Patients
Colorectal Cancer -Toxicity Form - Subset of Patients

Cycle(s) _____/_____

Colorectal Cancer - Adjuvant Disease Treatment Summary Form
Colorectal Cancer -Toxicity Form – Summary

End of Treatment

Colorectal Cancer - Follow Up Form
Colorectal Cancer – Secondary Resection Follow Up Form
Pathology Report and Pathology Report Cover Sheet
Operative Report and Operative Report Cover Sheet

Follow-Up Visit #____

Unscheduled

Data Clarification Form(s)
Site Initiated Data Update Form
Memo/Note to File
Other _________________
.
Contact Information: Westat, CTSU Data Operations Center, 1441 West Montgomery Avenue, Rockville, MD 20850-2062

Form Version: 24-Mar-2010 (Updated 24-Mar-2010)