Safety Management Plan

The Safety Management Plan is one of the most important documents in a clinical trial and it is used by clinical trial sponsors to minimize the risks for trial subjects and patients. The core purpose of the Safety Management Plan is to define the roles, responsibilities, processes, and timelines for drug safety activities distributed among the involved parties. It regulates all clinical safety-related communications between the Sponsor, the Contract Research Organizations (CROs), the pharmacovigilance services provider and/or safety database provider, and potentially additional parties.