Data Transmission Form

Attachment_A10_rtog0834_DTF

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

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

Attachment_A10_rtog0834_DTF

RTOG-0834 CTSU DATA TRANSMITTAL FORM
For Post-Enrollment Data Submissions
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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: ____ ____  ________
(ddmmyyyy

Patient ID#:

Total # Pages Faxed:
(Including Transmittal

(EORTC Sequential IDENT. No.

(Institution

NCI CTEP Code:
(Internal ID

Site Address:

INST. No:

Site Name:

Phone #:

Transmittal Completed By:
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 his wi h o her
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: July 2018

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

Attachment_A10_rtog0834_DTF

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: July 2018

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