This required system for cancer centers has a committee composed of ten members and the unit is headed by Carlos Carrera, M.D. The committee has statistical and primarily clinical representation, with ad hoc additional basic scientist reviewers. There are 4 aims which include providing peer review of all cancer-related clinical protocols; review of protocol progress; authorization of continuation or discontinuation of protocols and prioritize protocols by discipline through the Specialized Cancer Units. From May 1999 through February 2000, the PRMS reviewed 87 protocols, 58 NCI, 16 institutional, and 13 from pharmaceutical companies. The PRMS has 4 categories of decisions: Approval, Approved Pending IND, Approved Pending Clarification, and Deferred. Monitoring is provided for informed consent (Level 1), for accrual (Level 2), and for in-depth monitoring (Level 3). The Chair, Dr Carlos Carrera, continues in his role from the prior submission.
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