ABSTRACT
At nearly every training course, workshop, or seminar on standard operating procedures (SOPs) the question floating around in many people’s minds is: “Why do I need SOPs,” or “Do I really have to have SOPs?” Sorry, but the answer is “Yes.” International Conference on Harmonization (ICH) guidelines and Food and Drug Administration (FDA) regulations explicitly require SOPs. The ICH document “E6 Good Clinical Practice: Consolidated Guidance” states:
5.1.1 — The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data is generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
