Form 19 Attach 1S - RTOG 0834 CTSU Data Transmittal Form

attach_1s_RTOG-0834_DTF

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

Public reporting burden for this collection of information is estimated to vary from 5 to 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-xxxx). Do not return the completed form to this address.

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

attach_1s_RTOG-0834_DTF

*STY-RTOG-0834*
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: __ __-__ __ -__ __ __ __
(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

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

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