6-8 November 2023
A new Question & Answer at EMA´s Good clinical practice (GCP) website addresses how sponsors can demonstrate oversight for those activities that are delegated by a written contract. Furthermore, reference is made to the Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) and the Guideline on computerised systems and electronic data in clinical trials (see also Notice to sponsors on validation and qualification of computerised systems used in clinical trials).
The sponsor should ensure that contractual arrangements do not interfere with the sponsor's ability to perform quality management. The following should be ensured:
The service provider may not perform all duties and functions delegated in a written contract and may choose to further delegate duties and functions to a different service provider. However, this should not impact the level of oversight by the sponsor. In order to still be able to demonstrate oversight, the following should be considered in addition:
Regardless of delegation of duties and tasks, the complete trial conduct should remain traceable and verifiable. Therefore, the sponsor should ensure that access to all trial relevant documents can be provided.
For more information please see Q&A 17 in the section "GCP Matters" at EMA´s GCP Website.