Form 14 TAILORx UDM

Attachment_14a_TAILORx_UDM
Attach_1b_IRBCRT

OMB#0925-0624
OMB#
0925-0624
0925-xxxx
Expiration Date:12/31/2013
Expiration
Date
Expiration
Date1/31/2017
xx/xx/xxxx

Public reporting burden for this collection of information is estimated to average 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 (OMB#0925-xxxx). Do not return the completed form to this address.
.

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

Unsolicited Data Modification Form (UDM)*
Protocol: TAILORx/ PACCT-1
INSTRUCTIONS
*The Unsolicited Data Modification Form template is attached to these instructions (2nd page of this document).

Submit a CTSU Unsolicited Data Modification Form [UDM], accompanied by a CTSU TAILORx
Data transmittal Form to update data provided on the original CRF OR to update data
previously entered into RDC.
• DO NOT SUBMIT AMENDED CRFs or COPIES OF CRFs. Said documents will not be processed.
• DO NOT SUBMIT A TAILORx UDM TO: (1) Update the Patient ID, (2) Update the Follow-Up Report Period,
(3) Update Reporting Period Start and End dates, (4) Redact patient identifiers on a previously submitted
CRF/Report or (5) Respond to a Data Clarification Form (DCF).
• SPECIAL INSTRUCTIONS TO REQUEST DELETION OF A FOLLOW-UP FORM: only submit a deletion
request for the following 2 reasons, using the standard text as specified, (1) “the wrong Patient ID
was specified” OR (2) “the wrong FUP Report Period was specified.”
1. Complete the UDM form requesting the Follow-Up form to be deleted (see example below).
2. Submit a NEW Follow-Up form with the correct Patient ID or Follow-Up Report Period specified.
Form Name
Visit / Month
FOLLOW-UP FORM
MONTH 12

Page
Number
ALL

Field / Question
on CRF
ALL

Current Value
Corrected / Updated
on CRF
Value To
ALL
DELETE FOLLOW-UP FORM, the wrong
PID was specified OR the wrong FUP
Report Period was specified

Contact the CTSU Helpdesk for questions (888) 823-5923.
CTSU Confidential

Revised 10/14/2013

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

Unsolicited Data Modification Form (UDM)
Protocol: TAILORx/ PACCT-1
Patient Number: __________ NCI Site Code: __________
Patient Initials: ________ Investigator Name: __________________________
Submit a CTSU Unsolicited Data Modification Form [UDM], accompanied by a CTSU TAILORx Data Transmittal Form to update data provided on the
original Case Report Form OR to update data previously entered into RDC.
DO NOT SUBMIT AN AMENDED CRF or COPIES OF CRFs. Said documents will not be processed.
DO NOT SUBMIT A TAILORx UDM TO: (1) Update the Patient ID, (2) Update the Follow-Up Report Period, (3) Update the Reporting Period Start and
End dates, (4) Redact patient identifiers on a previously submitted CRF/Report, or (5) Respond to a DCF.

To be Completed by the Site:
Form Name
Visit / Month

Page #

Field / Question
on CRF

Current Value on CRF

CRA/ Investigator Signature: ___________________________________________

Corrected / Updated Value

Date: ________________

Contact the CTSU Helpdesk for questions (888) 823-5923.
CTSU Confidential

Revised 10/14/2013