Drug Evaluation Committee 2019-31 Browsing Accuracy Control, etc. of External Laboratories
Related classification: Other
Date of first publication: 09/2019
Question
We received a request from a monitor to inspect the accuracy control records of an external medical institution (ophthalmology testing is outsourced) in an ongoing company-initiated clinical trial. We think that the monitor of the clinical trial should be in charge of negotiating with the external medical institution to allow direct access to the accuracy control records, but should our hospital, which has outsourced some of the inspections related to the clinical trial, be in charge of this?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The outside medical institution in your question is a trustee to which the site has entrusted part of the work related to the implementation of the clinical trial in accordance with Article 39-2 of the GCP, and the site is responsible for supervising the outside institution. The medical institution should confirm that the contractor's operations are being conducted appropriately and smoothly, and the medical institution should also confirm that accuracy control is being conducted appropriately and explain this to the sponsor.
On the other hand, although GCP requires that clinical trial-related records be made available for direct inspection upon request of the site auditor or regulatory authority, there is no provision for monitors to directly inspect fiduciary materials (Article 39-2 Guidance 10 of GCP). In order for monitors to inspect fiduciary materials, the contract between the site and the fiduciary must include a clause regarding direct inspection by the sponsor, or a separate contract including the sponsor is required.
If an agreement is concluded for the sponsor to directly inspect the fiduciary's materials, the sponsor and the site should discuss negotiations with the sponsor, and either party may conduct the negotiations.