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1	Regulatory Documents and the CTSU
2	Regulatory Documents All regulatory documents for US sites are submitted to the CTSU for cataloguing and data entry Continuing Reviews (open studies) Approvals of amendments/revisions when mandated IRB initial study approvals IRB approved consent forms
3	Special Handling Canadian Regulatory Documents are submitted directly to RTOG HQ Handling of all other study specific regulatory documentation is detailed in the protocol Study Agent Shipment Form (SASF) Sponsor required documentation Questionnaires Certifications
4	CTSU Forms & Guidance Can be found on the RTOG website www.rtog.org under member info/CTSU Institution NCI codes IRB certification forms IRB transmittal forms Guidance for completing the forms Flow sheet
5	Resolving Regulatory Issues All issues with submitted regulatory documents should be handled directly through the CTSU. RTOG does not have access to copies of regulatory documents that have been submitted to the CTSU.
6	CTSU Contact Information Help Desk: 1-888-823-5923 E-mail: ctsucontact@westat.com Fax Number: 215-569-0206 Mailing Address: CTSU Regulatory Office Coalition of National Cancer Cooperative Groups 1818 Market Street, Suite 1100 Philadelphia, PA 19103