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SOP 2 defines the composition and procedures of the Project Review Committee (PRC) of CESAR. The PRC works independently of the time schedule of working group meetings, and its task is to ensure a rapid and objective evaluation of trial projects proposed to CESAR via its working groups and the prompt activation of approved studies. The PRC’s decision must take into consideration the interests of CESAR to have adequate information on the investigational drug and the proposed project while at the same time maintaining the strictest secrecy of confidential information provided by a sponsor.

SOP 02: Evaluation and Selection of a Clinical Trial Proposal for CESAR