Standard operating procedure

According to ICH-GCP, an SOP, also known as a Standard Operating Procedure, is a work instruction to ensure uniform work processes in a Clinical Research Organisation (CRO) or at the sponsor of a clinical study. According to GCP, the sponsor is responsible for the implementation and maintenance of quality assurance with written SOP 's. As a rule, contract research organisations have their own SOPs, so that the clinical study can be carried out either according to the specifications of the sponsor or the commissioned CRO.

SOP 's concern all work steps in a clinical study. Their task is to ensure that the observation plan or study protocol is implemented and that all procedures are carried out in accordance with the rules, taking into account GCP, AMP and MPG and all applicable laws and guidelines.

SOP 's are considered to be an essential quality feature in the conduct of studies, as they create transparency in the working methods applied and facilitate the procedure for order fulfilment and uniform working within a company. Depending on the type of study, there are more than 70 different Standard Operating Procedures, covering planning, statistical analysis / biometrics, randomisation, database programming, regulatory procedures, handling of investigational medicinal products, monitoring, pharmacovigilance and SAE notification, coding, medical writing, preparation of numerous documents, administration, archiving, contract drafting and audits.