Regulatory Document Collection

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International sites will submit regulatory documents to the Clinical Trials Support Unit (CTSU).  All IRB/REC approvals, informed consent documents, verified translation documents, and other regulatory documents listed in section 5 of the protocol will be sent to the CTSU Regulatory Office. 

CTSU is a service of the National Cancer Institute’s (NCI) Cancer Evaluation Therapy Program (CTEP). The CTSU facilitates access to clinical trials, as well as provide services on behalf of the Cooperative Groups to assist the participating sites. One of the services provided by the CTSU is the centralized collection of regulatory documents by the CTSU Regulatory Office.  The packets below provide further information about CTSU and regulatory document collection.

Institutions will continue to submit their Letter of Intent (LOI) to RTOG.  RTOG will review the LOI and notify the institution, CTSU, and RTOG study team.

RTOG International Site Welcome Packet

CTSU Information Packet