Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 57

4.8 Standard Operating Procedures

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The ICH E6(R2) lists the expectations for the development and use of Standard Operating Procedures (SOPs) in numerous sections. SOPs are generally viewed as a bedrock element in the requirements associated with the manufacturing and testing, labeling etc., for pharmaceutical medicinal products. However in the regulatory requirements promulgated by the US FDA defining the conduct of clinical trials at 21 CFR 312 – Investigational New Drug Applications the term procedures and/or standard operating procedures is not mentioned. Regulatory authorities such as the US FDA certainly expect sponsors and investigators to have written procedures for key processes and procedures in place but the requirements specifically stating that are just not there. The FDA’s regulations for IRBs and informed consent do speak to written procedures. However is clear on the need and expectation for written procedures. It is apparent in numerous sections e.g. 5.18.15 Monitoring Procedures and Auditing Procedures. A quick survey of the guideline shows numerous instances where the term procedures is used and it refers to SOPs. Regulators can, if needed cite the ICG E6(R2) as the standard whereby written SOPs are necessary and required for virtually every functional aspect of a clinical trial.

The Fundamentals of Clinical Research

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