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SECTION 5: RADIATION THERAPY GUIDELINES

Protocols using radiation therapy will contain a specific section delineating the delivery and management of this treatment modality. This section describes the procedures that will need to be initiated at the site prior to enrolling patients on CTSU protocols where radiation therapy is a treatment intervention.

All radiation therapy facilities MUST participate in the Radiological Physics Center (RPC) monitoring program to be eligible to deliver radiation therapy for NCI-sponsored protocols (including Cooperative Group studies).
Radiation therapy facilities not currently participating in RPC monitoring may contact CTSU to begin the process.
Instructions for submission of radiation therapy materials by CTSU investigators are always included in the protocol. CTSU sites follow the Cooperative Group's guidelines for the delivery and management of radiation therapy.
The sponsoring Cooperative Group determines if the protocol contains a radiation therapy question. If a radiation therapy component is identified, a Radiation Therapy Facilities Inventory Form (RTFI) must be submitted to the CTSU as part of the site registration packet. This form is located on the CTSU Registered Member Web site on the protocol page of any relevant study (under Site Registration Documents), and also under the Resources tab (see generic forms near the bottom). If a site already has an RTFI on file with the CTSU, a new form does not need to be submitted for each new study. Sites should submit an updated form if information about the facility has changed. Please note update on the front page of the form.
The RTFI is reviewed by the CTSU and monitoring is conducted by the RPC.

Section topics include:
Cooperative Group Specific Guidelines
Radiotherapy Materials Submission

Module Objectives
1
Identify specific regulatory documentation, medical records, and laboratory certification that must be maintained according to Federal regulations and Good Clinical Practice
2
Describe the procedure for submission of data to the CTSU
3
Implement the procedures to acquire study agents specific for a protocol on the CTSU menu
4
Demonstrate the procedure for reporting adverse events for patients enrolled through the CTSU
5
Summarize radiation therapy guidelines that will need to be initiated at the study site prior to enrolling patients on CTSU protocols where radiation therapy is a treatment intervention
6
Describe the rationale and process for auditing data obtained for patients enrolled on a CTSU protocol
7
Explain CTSU Quality Assurance
Cooperative Group Specific Guidelines
Cooperative Group
Data
Data Repository*
CALGB Radiotherapy Materials
Dosimetry Data
Quality Assurance Review Center
http://www.qarc.org
ECOG

Radiotherapy Materials
Dosimetry Data

Quality Assurance Review Center
http://www.qarc.org
NSABP Radiotherapy Materials
Dosimetry Data
NSABP Biostatistical Center
RTOG Radiotherapy Materials
Dosimetry Data
RTOG Dosimetry Department
SWOG Radiotherapy Materials
Dosimetry Data
Quality Assurance Review Center: http://www.qarc.org
*Name of contact person is identified in the protocol
Radiotherapy Materials Submission
Radiotherapy materials, such as films and preliminary and final dosimetry information, are submitted directly to the address listed on the protocol. Do not send these materials to the CTSU.
Call the CTSU Help Desk at 1-888-823-5923 with questions.

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