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研究者撰写方案的行政负担 建立、实施和维护CTEP集中式方案编写支持（CPWS）计划，该计划应包括但不限于标准化沟通、文件编写和跟踪流程，以简化临床试验的开发。承包商应提供标准化、集中化的方案ICD撰写支持，以根据CTEP的指导选择研究，从意向书（LOI）批准到初始方案批准。 该任务单还将涵盖在COR批准后可能进行的修订。目标是缩短从LOI批准到方案批准的时间，并将方案修订的数量减少到两次以下。

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.