Loterre: SAGE: standard operating procedures

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standard operating procedures

As defined by the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), standard operating procedures (SOPs) are “detailed, written instructions to achieve uniformity of the performance of a specific function.” SOPs document what the clinical research site does in its daily practice and are uniformly formatted to contain the purpose, policy, scope, and definitions associated with this practice. The goal of SOPs is to provide a method of clinical trials performance and documentation that embodies the high standards of good clinical practice. [Source: Encyclopedia of Health Care Management; Standard Operating Procedures]

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