Abstract

Pre-established, systematic written procedures for the management, organisation, conduct, data collection, documentation and verification especially of clinical trials; SOP should describe the step-by-step actions necessary to initiate and complete the task required in each job description; SOP assure correctness, consistency and completeness in an operation and shorten training periods; EC guidelines request that sponsors “establish detailed SOPs to comply with good clinical practice” (or good laboratory practice, good manufacturing practice resp.) and that the monitor “works according a predetermined SOP”.

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