Form 1 RTOG 0834 CTSU Data Transmittal Form

Attachment_A10_rtog0834_DTF

OMB# 0925-0753
Expiration Date 07/31/2021

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 (0925-0753). 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_A10_RTOG0834_DTF

OMB# 0925-0753
Expiration Date 7/31/2021

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 submitting)
Do not include more than 50 files or files with a cumulative size larger than 20 MB in a single 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 Submitted: _________
(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 submitted to the CTSU via the CTSU’s Regulatory Submission Portal (use the Paper
CRFs/Queries option in the first dropdown). Call 1-888-823-5923 if experiencing difficulty.
Do not fax or mail forms to the CTSU or 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
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 Help Desk, 1-888-823-5923

Form Version: November-1, 2020

Page 1 of 2

Attachment_A10_RTOG0834_DTF

Item(s) Attached

OMB# 0925-0753
Expiration Date 7/31/2021

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
After the end of Radiotherapy, All Arms:
4 weeks after the end of Radiotherapy
AND thereafter for every 6 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 6 months for 5 years

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)

4 Weeks after end of Radiotherapy
Thereafter every 6 months until disease progression
At disease progression

End of Treatment Form (Form 14)

Follow Up Form (Form 15)

End of Protocol Treatment (or in case patient is not
randomized)
Arms 3 & 4 only:
At disease progression
Due every 6 months after disease progression and until
patient’s death

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

Contact Information: Westat, CTSU Help Desk, 1-888-823-5923

Form Version: November-1, 2020

Page 2 of 2