NCI-designated Cancer Centers conducting clinical research are required to have a NCI-peer reviewed
Protocol Review and Monitoring System (PRMS), which provides the Cancer Centers with a mechanism to
peer review all cancer clinical trials in the institution for scientific quality and merit prior to
their activation. The PRMS is also responsible for prioritization, monitoring, and termination of
protocols based on scientific progress and patient accrual. The policies and processes of the PRMS
must be approved through a formal peer review process at each renewal of the Center's NCI Cancer
Center Support Grant in order for trials to be activated and have access to grant-funded resources.
The functions of the PRMS are complementary to the institution's IRB, which evaluates and monitors
human subject and related regulatory issues.
The clinical trials approved by the NCI-designated Cancer Center's PRMS mechanism are considered
as having been through a peer-review process equivalent to the process for clinical trials and
research studies approved directly by other NCI scientific review mechanisms, such as Cooperative
Groups, NCI Protocol Review Committee approved studies, and NCI grant studies. Clinical trials
reviewed and approved under all these mechanisms qualify as NCI-sponsored studies. The processes
for monitoring and auditing of clinical trials are defined by the mechanism they are supported under.