How can Sponsors Demonstrate Oversight for Delegated Activities?

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).

Demonstration of Sponsor Oversight

The sponsor should ensure that contractual arrangements do not interfere with the sponsor's ability to perform quality management. The following should be ensured:

• Access to essential documents that are retained at the contracted service provider;
• Documentation of access (e.g. access log);
• Recording of significant decisions and actions (e.g. in meeting minutes);
• Archiving of relevant communication (e.g. Emails);
• Logging of document (and data) review steps (e.g. audit trail review);
• Logging of relevant phone calls (help desk) (e.g. ticket system, minutes of the call);
• Documented acknowledgement of QA reports (e.g. audit report);
• A life cycle process to adapt and re-evaluate documentation and training requirements (e.g. change management SOP);
• Recording and evaluation of deviations from contractual agreements, GCP or regulatory requirements.

Sub-Contracting

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:

• Explicit contractual details about the service provider’s ability to subcontract duties and functions to other service providers;
• Documented evaluation of the processes of the service provider to assess and have oversight over subcontracted duties and functions.

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.