Guest guest Posted January 1, 2010 Report Share Posted January 1, 2010 Standard Operating Procedure (SOP) defines the process for writing, reviewing, distributing and amending SOPs within the ethics committee. These SOPs provide clear, unambiguous instructions so that the related activities in the ethics committee are conducted in accordance with the Ethical Guidelines for Biomedical Research on Human Subjects. Different Definitions: A set of fixed instructions or steps to be followed routinely for the performance of designated operations. (Webster’s Dictionary) Detailed, written instructions, in a certain format, describing all activities and actions undertaken by an organization to achieve uniformity of the performance of a specific function. (ICH-GCP) Standard elaborate written instructions to achieve uniformity of performance in the management of clinical studies. SOPs provide a general framework for the efficient implementation and performance of all the functions and activities related to a particular study. (Indian GCP) Dr. Smita The INTERNET now has a personality. YOURS! See your Homepage. Quote Link to comment Share on other sites More sharing options...
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