ABSTRACT
If a clinical trial is being conducted according to ICH E6 GCP, then according to Section 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 are generated, documented (recorded), and reported in compliance with the
protocol, GCP, and the applicable regulatory requirement(s) [ emphasis added].” In addition to this broad requirement, additional, more specific, references to SOPs follow, which make clear that SOPs are expected to be in place for all key activities associated with a clinical trial. For monitors, Section 5.18.2 (“Selection and Qualification of Monitors”) says, “(c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).” And for data management, Section 5.5.3 says, “When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should: … (b) Maintain SOPs for using these systems.” In order to be in compliance with ICH E6 GCP, all biopharmaceutical companies must have SOPs for clinical trial activities.
