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?
JPMA's Opinion
The external medical institution in your question is a contractor to which the Investigator 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 Investigator Site is responsible for supervision of this external institution. The Investigator Site should confirm that the contractor's operations are being performed properly and smoothly, and the Investigator Site should also confirm that accuracy control is being performed properly and explain this to the sponsor.
On the other hand, GCP requires that clinical trial-related records be made available for direct inspection upon request of the Investigator Site's auditor or regulatory authorities, but there is no mention of direct inspection of fiduciary materials by monitors (GCP Article 39-2 Guidance 10). In order for monitors to inspect fiduciary materials, the contract between Investigator 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's direct access to the trustee's materials, the Investigator Site and the sponsor should discuss negotiations with the trustee, and either party may conduct the negotiations.