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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 ctsucontact@westat.com
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
File Type | application/pdf |
File Modified | 2010-10-13 |
File Created | 2010-05-13 |