Thursday, 12 October 2023 9 .00 - 17.30 h
EMA's GCP Inspectors Working Group (IWG) recently revised Question & Answer No. 11 in the section "GCP matters" of the Good Clinical Practice (GCP) Q&As.
Based on the trial design and setting, the sponsor may support the investigator by contracting service providers or personnel to be involved directly in the conduct of the clinical trial. In the opinion of the GCP IWG this is possible, provided the approach is compliant with the applicable EU laws and with the ICH E6 guideline requirements. There are aspects that need to be carefully considered to ensure that the division of roles of the responsible parties is maintained (see also the Recommendation paper on Decentralized Elements in Clinical Trials).
However, it is emphasized that the investigator is still responsible for any outsourced tasks involving trial-related medical decisions and the appropriate supervision of the persons or parties undertaking the activities delegated. Any trial related procedure that is delegated to a service provider should be specified in a written agreement. Where the agreement is between the sponsor and the service provider and involves tasks under investigator responsibility, it should be clear in the respective agreements (i.e. sponsor/service provider, sponsor/investigator) that the investigator maintains adequate control and oversight over the contracted tasks.
For more information please see EMA's Q&A: Good clinical practice (GCP).