Form 14 Attach 1N - Unsolicited Data Modification Form (UDM), Pr

Attach_1n_PACUDM

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_1n_PACUDM

Unsolicited Data Modification Form (UDM)
Protocol: TAILORx/ PACCT-1

Patient Initials:

Patient Number:

Investigator Name:

DO NOT SUBMIT THE AMENDED CRF: Please submit the CTSU Unsolicited Data Modification Form, accompanied by a CTSU Data Transmittal Form.
Do not amend this form. If further changes are necessary, a new Data Modification Form must be completed.

DO NOT SUBMIT UDM TO: (1) Update Patient ID on submitted CRF/Report (2) Redact patient identifiers (3) Re-submit data
*Contact CTSU Helpdesk for questions (888) 823-5923.

SPECIAL INSTRUCTIONS FOR UPDATES TO VISIT/MONTH ON CRF: Two entries are necessary.
(1) Specify Form with the incorrect Visit/Month and note "Form to be deleted" in the Corrected/Updated Value column.
(2) Specify Form with correct Visit/Month and note "Update to correct reporting period" in the Corrected/Updated Value column.

Form Name
Visit/ Month

CRA Signature:

Page
Number

Field/ Question
On CRF

Date:

Current Value
On CRF

Investigator Signature:

CTSU Confidential

Corrected/ Updated Value

Date:

Revised 01/13/2009