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协议的行政负担 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、文档编写和跟踪的流程，以简化临床试验的开发。承包商应提供标准化、集中化的协议ICD编写支持，以根据CTEP的指示从意向书(LOI)批准到初始协议批准来选择研究。该任务单还将涵盖COR批准后可能进行的修订。目标是减少从意向书批准到协议批准的时间，并将协议修订的数量减少到不到两次。

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.