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.