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Cancer Trials Support Unit & Regulatory Support Service

Cancer Trials Support Unit

The Cancer Clinical Trials Support Unit (CTSU) is a pilot project initiated by the National Cancer Institute in 1999, awarded to Westat, Oracle, and the Coalition of Cancer Cooperative Groups. The initiative provides greater access to Phase III clinical trials sponsored by the National Cancer Institute and facilitates investigator participation by offering comprehensive clinical trials management.

In addition to providing high-quality data to the adult Cooperative Groups, the CTSU serves as a liaison to each group’s operational, statistical, and data management centers, as well as their extensive investigator network. The Coalition of Cancer Cooperative Groups interacts with Westat personnel and functions as principal subcontractor. The Coalition provides direct leadership for many CTSU activities, including education and promotion, regulatory compliance adherence, financial management services, and auditing of participating site for compliance.

Regulatory Support Service

The Regulatory Support System (RSS) is a database containing regulatory documents for all treatment trials conducted for adult Cooperative Group research sponsored by the National Cancer Institute. The system’s central processing facility resides in the Coalition’s Philadelphia headquarters. The RSS in Philadelphia works closely with all Adult Cooperative Groups to facilitate this centralized process and also serves as a conduit for secondary review of documents.