Standard Operating Procedures
SOPs are defined by ICH as “detailed, written instructions to achieve uniformity of the performance of a specific function.” Federal regulations state, “A sponsor shall select only investigators qualified by training and experience...” (21 CFR 312.53) and that “[The investigator] will ensure that all [staff] are informed about their obligations...” (21CFR 312.53).
SOPs are a necessary tool for a clinical site to guarantee standardization, safety, and efficiency of the clinical research team. Since the most frequently reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them, OCRSS provides SOP development services to university investigators and research programs.
This service includes determining the scope of the procedures, mapping the internal processes, and determining a clear delineation of duties and responsibilities of the research team.