Form 11 Attach 1K - Site Initiated Data Update Form (DUF), Proto

Attach_1k_N0147_DuF

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_1k_N0147_DuF

SITE INITIATED DATA UPDATE FORM (DUF)
PROTOCOL: NCCTG N0147
Patient Initials: ______

Patient Study ID: __________________

Investigator Name: _____________________

PLEASE PRINT CLEARLY AND LEGIBLY; read these instructions carefully before completing this form.
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Be sure to complete: 1) Header information at the top of this form, 2) each column below for all updates and 3) signature and date at the bottom of the form.
Investigator signature is optional.
DO NOT LIST UPDATES FOR MULTIPLE CRFs ON THIS FORM: manage only one CRF per Data Update Form. Use a separate Data Update Form for each CRF.
DO NOT SUBMIT AMENDED CRFs: this form is appropriate ONLY for updating previously submitted Case Report Form (CRF) data. The N0147 study has not accepted
amended CRFs since 05/08/2009.
DO NOT use this form to: 1) update Patient IDs on any CRF/Report, 2) redact patient identifiers, or 3) resubmit data/ documents.
This form is appropriate ONLY for site initiated data changes: if the CTSU issued a Data Clarification Form (DCF) for a data discrepancy, submit only the DCF with the
correct value specified in the resolution box of the DCF.
Always submit this form with a N0147 CTSU Data Transmittal Form.
For questions, contact the CTSU Help Desk at 888-823-5923 or [email protected]

Form Name & Visit

CRA Signature:

Page
Number

Field/Question on CRF

Date:

Current Value on CRF

Investigator Signature:

CTSU Confidential

Corrected/Updated Value

Date:

Created 05/08/2009
Revised 03/24/2010