Documents and Memos for CTEP-Supported Trials

CTEP’s memos and guidelines are intended to ensure patient safety. They also provide the National Cancer Program with the most effective new agent development program possible. Some documents reflect the regulatory requirements of the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS). Others have been developed based on policies at the Institute level, consensus among CTEP staff, NCI advisory boards, and leaders in the community of clinical investigators. Specific memos and procedures continue to evolve; through them CTEP, DCTD, NCI aims to provide a flexible, responsive system within the constraints imposed by regulation and the program’s size and scope.