In brief
On 23 June 2023, EMA’s GCP Inspectors Working Group updated the Q&A on Good Clinical Practices (GCP).
Key takeaways
In particular, the update has allowed for the possibility, if in compliance with applicable European regulations and the requirements of ICH E6 guideline, that the sponsor may support the investigator by identifying or contracting service providers or personnel to be directly involved in the conduct of the clinical trial (e.g., by providing additional resources to the clinical trial site or qualified personnel).
The Q&A also indicates that to maintain and ensure the division of roles, the investigator is required to adopt several measures, including, the final decision on the appropriateness of the service provider, the final responsibility for any task involving trial-related medical decisions, and the supervision of persons or parties undertaking the activities delegated.
In addition to this, any trial-related procedure that is delegated to a service provider should be indicated in a written agreement in which it is specified that the investigator maintains control and oversight over the contracted activities.
Finally, the Q&A focuses on the use of productivity application in clinical trials and provides relevant considerations if remote access to identifiable personal and health data is required in a clinical trial.
