TASK ORDER 5A: CENTRALIZED PROTOCOL WRITING SUPPORT; CONTRACT TITLE: CANCER TRIALS SUPPORT UNIT CTSU.

承包商应通过以下方式减轻调查人员撰写方案的行政负担

The Contractor shall reduce the administrative burden of protocol writing for investigators by establishing, implementing, and maintaining a CTEP Centralized Protocol Writing Support (CPWS) program which shall include, but is not limited to, processes for standardized communication, document writing, and tracking to streamline the development of clinical trials. The contractor shall provide standardized, centralized Protocol ICD writing support to select studies as directed by CTEP from Letter of Intent (LOI) approval through initial Protocol approval. This task order would also cover potential amendments after approval of the COR. The goals are to reduce the time from LOI approval to protocol approval and to minimize the number of protocol revisions to less than two.