Form 10 Site Initiated Data Update Form

Attachment_1j_siteduf
Attach_1i_CTSUdata_update_form

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

Public reporting burden for this collection of information is estimated to average 10 minutes per response,
Public reporting
burden
for this
collection searching
of information
is estimated
to vary
from 5and
to maintaining
10 minutes per
response,
including
the time for
reviewing
instructions,
existing
data sources,
gathering
the data
including
time for and
reviewing
instructions,
searching
existing data
sources,
gathering
and or
maintaining
the data
needed,
and the
completing
reviewing
the collection
of information.
An agency
may
not conduct
sponsor, and
needed,
completing
and reviewing
the collection
of information.
agency amay
not conduct
or sponsor, and
a person
is and
not required
to respond
to, a collection
of information
unlessAn
it displays
currently
valid OMB
a person
is not
required
to respond
collection
of information
a currently
valid OMB
control
number.
Send
comments
regardingto,
thisa burden
estimate
or any otherunless
aspect it
of displays
this collection
of information,
control suggestions
number. Send
comments
regarding
burden
estimate
or anyBranch,
other aspect
this collection
of MSC
information,
including
for reducing
this
burden, this
to: NIH,
Project
Clearance
6705 of
Rockledge
Drive,
7974,
Bethesda,
20892-7974,
ATTN: PRA
(0925-0624).
DoProject
not return
the completed
this address.
includingMD
suggestions
for reducing
this burden,
to: NIH,
Clearance
Branch, form
6705 to
Rockledge
Drive, MSC 7974,
Bethesda, MD 20892-7974, ATTN: PRA (0925-0624).
(0925-xxxx). Do not return the completed form to this address.

Filling out PDF Forms
This PDF form contains “roll-over or double-click ” help functionality.
This form allows you to enter data directly onto the screen. After completing the form,
you are able to print the document so that you can fax/mail the document.

To fill out a form:
1. Select the hand tool.
2. Position the pointer inside a field, and click to type text.
3. After entering text or selecting a check box, do one of the following:
- Press tab to accept the form field change and go to the next form field.
- Press Shift+Tab to accept the form field change and go to the previous form
field.
- Press Enter (Windows) or Return (Mac OS) to accept the form field change and
deselect the current form field.
4. Once completed, print the form.

Attachment_1j_siteduf
Attach_1i_CTSUdata_update_form

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

Site Initiated Data Update Form
Protocol: __________
PATIENT INITIALS:

PATIENT NUMBER:

CRF NAME: __________________

INVESTIGATOR NAME:

VISIT/CYCLE #:___________________________

Instructions:
Use this form to submit data updates to a single CRF.
A separate Data Update Form must be completed for each CRF that needs to be updated.
Enter one update per row in the table below.
Fax completed form to the CTSU (DO NOT submit amended CRF).
Data Update Form must be accompanied by a CTSU Data Transmittal Form.
Submit future updates to the same form on a new Data Update Form, do not re-submit an updated Data Update Form.
Please retain a copy of this signed and dated Data Update Form for patient record.
Field/Question

Investigator or designee Signature:

Current Value

Correct/Updated Value

Date:

Contact the CTSU Helpdesk with any questions: (888) 823-5923 or CTSUContact@Westat.com
CTSU Confidential
Version 2: 1-Sep-2010