Quality systems


"Systems with procedures that assure the quality of every aspect of the trial should be implemented" [ICH-GCP E6 2.13].


Clinical trials are demanding in terms of specific requirements and procedures that meet the clinical trial protocol requirements. It is recommended that especially where multiple staff members are involved, that standard operating procedures be set up that outline process steps, responsibilities of staff members, documentation/systems to be used and timelines for completion of tasks.


"Standard Operating Procedures: “Detailed, written instructions to achieve uniformity of the performance of a specific function”
[ICH-GCP E6, 1.55]