Form 12 RTOG 0834 CTSU Data Transmittal Form

Attachment_1l_rtog0834
attach_1s_RTOG-0834_DTF

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

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 5
to maintaining
10 minutes per
response,
including
the time for
reviewing
instructions,
existing
data sources,
gathering
and
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
it displays
a currently
valid OMB
control
number.
Send
comments
regardingto,
thisa burden
estimate
or any otherunless
aspect of
this collection
of information,
control suggestions
number. Send
comments
thisNIH,
burden
estimate
or anyBranch,
other aspect
this collection
information,
including
for reducing
thisregarding
burden, to:
Project
Clearance
6705 of
Rockledge
Drive,ofMSC
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
6705to
Rockledge
Drive, MSC 7974,
Bethesda, MD 20892-7974, ATTN: PRA (0925-0624). 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.

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

attach_1s_RTOG-0834_DTF
Attachment_1l_rtog0834

*STY-RTOG-0834*
RTOG-0834 CTSU DATA TRANSMITTAL FORM
For Post-Enrollment Data Submissions
•
•
•
•
•
•
•

Use this form for post-enrollment data submissions; do not use this form to submit site registration/patient enrollment documents
Record only one patient and protocol per transmittal form
Ensure Patient ID and Protocol ID are recorded on each page of each item included
Ensure pages are in proper sequence (2-sided forms must be copied by site before faxing)
Do not fax more than 50 pages in one submission
Changes to data initiated by the site must be reported on the Data Correction Form
Submit updated data with a new CTSU Data Transmittal Form and new date

Date: __ __-__ __ -__ __ __ __
(dd-mm-yyyy)

Total # Pages Faxed: _______
(Including Transmittal)

Patient ID#: __ __ __ __
(EORTC Sequential IDENT. No.)

Site Name: ______________________________________________________________
(Institution)

NCI CTEP Code: __ __ __ __ __
(Internal ID)

Site Address: ____________________________________________________________

INST. No: __ __ __ __

Transmittal Completed By: ___________________________________________ ____

Phone #: ______________________

Email address: ___________________________________________________________
The item(s) listed below should be faxed to CTSU at 1-301-545-0406. Call 1-888-823-5923 if experiencing difficulty faxing.
Do not mail forms to CTSU. Do not fax or mail forms to the EORTC Data Center
Number
Item(s) Attached
Visit
of pages

Query Form (Query)
Data Correction Form (DCF)
Local Pathology / Genetic Testing (Form 2)

Before Randomization

On Study Form (Form 5)

Before 1sttreatment administration (Send this with other
baseline forms)

Hematology Form (Form 6)

Baseline, All Arms:
Within 4 weeks before randomization
During Radiotherapy, Arms 2 & 4:
Week 1, 2, 3, 4, and 5 for TMZ administration
End of Radiotherapy, Arms 2 & 4:
Week 6
After the end of Radiotherapy, All Arms:
4 weeks after the end of Radiotherapy
Adjuvant TMZ, Arms 3 & 4:
Additional Assessments

Biochemistry Form (Form 7)

Baseline, All Arms:
Within 4 weeks before randomization
During Radiotherapy, Arms 2 & 4:
Week 4
End of Radiotherapy, Arms 2 & 4:
Week 6
After the end of Radiotherapy, All Arms:
4 weeks after the end of Radiotherapy
Adjuvant TMZ, Arms 3 & 4:
Additional Assessments

Contact Information: Westat, CTSU Data Operations Center, 1-888-823-5923

Form Version: May 26, 2010

Page 1 of 2

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

Attachment_1l_rtog0834
attach_1s_RTOG-0834_DTF

*STY-RTOG-0834*
Item(s) Attached

Number
of pages

Visit
Baseline, All Arms:
Within 4 weeks before randomization

Adverse Event Form (Form 8)

During Radiotherapy, All Arms:
Week 1, 2, 3, 4 and 5
End of Radiotherapy:
Week 6
After the end of Radiotherapy, All Arms:
4 weeks after the end of Radiotherapy
AND thereafter for every 3 months until disease progression
At disease progression
Adjuvant TMZ, Arms 3 & 4:
Additional Assessments
Within 4 weeks before randomization
4 Weeks after Radiotherapy
Thereafter every 3 months until disease progression or death
At disease progression
Follow up

EORTC QLQ-C30
EORTC QLQ-BN20

Neurocognitive Function Forms: *
Hopkins Verbal Learning Test-Revised (Hopkins
VL): Forms 1 - 6
Trail Making Test Part A (TM Part A)
Trail Making Test Part B (TM Part B)
Controlled Oral Word Association (COWA):
Forms 1 and 2
TMT Data Summary Form
Form CS
Form QP

*

For patients participating in this component

Baseline
Thereafter for yearly intervals until tumor progression or death

Radiotherapy Form (Form 9)

At the end of Radiotherapy

Patient Evaluation During RT Form (Form 10)

Week 4 during Radiotherapy
Week 6 during Radiotherapy

Concomitant Temozolomide Form (Form 11)

Arms 2 & 4 only: at the end of concomitant chemotherapy

Adjuvant Temozolomide Form (Form 12)

Arms 3 & 4 only: After each cycle of Adjuvant
Chemotherapy
Cycle: ______

Disease Assessment Form (Form 13)
End of Treatment Form (Form 14)

Follow Up Form (Form 15)

4 Weeks after end of Radiotherapy
Thereafter every 3 months until disease progression
At disease progression
End of Protocol Treatment (or in case patient is not
randomized)
Arms 3 & 4 only
At disease progression
Due every 3 months after disease progression and until
patient’s death

For CTSU use only: Short Name shown in (brackets)

Contact Information: Westat, CTSU Data Operations Center, 1-888-823-5923

Form Version: May 26, 2010

Page 2 of 2