Drug Evaluation Committee 2007-35 Necessity of including a provision in the clinical trial agreement that the sponsor will be present at GCP site inspections
Related classification: Clinical trial contract procedures
First published: 08/2008
Revised publication date: Apr 2013
Question
Is it acceptable for the sponsor to be present during investigations by regulatory authorities?
Background of the question
Recently, when signing a new clinical trial agreement with a foreign company, we received a request to include a clause in the agreement stating that "Investigator Site shall permit the presence of the sponsor at inspections or meetings related to this clinical trial by the regulatory authorities.
In fact, is the presence of the sponsor permitted when an on-site inspection is conducted at the medical institution? Also, do we have to accept this kind of agreement?
The term "regulatory inspections" includes both domestic and international inspections.
JPMA's Opinion
The notice issued by the Pharmaceuticals and Medical Devices Agency regarding GCP on-site inspections of drug application materials does not mention whether or not the sponsor can be present during the on-site inspection at the Investigator Site.
On the other hand, there is a possibility that overseas regulatory authorities may investigate Investigator Sites in Japan when submitting an application for approval overseas. Many overseas regulatory authorities, including the U.S. FDA, allow the sponsor to be present during investigations at Investigator Sites. Considering the differences in language and regulatory requirements in each country, the presence of a sponsor who understands these differences may be desirable to facilitate the investigation.
In any case, the presence of the sponsor is not possible without the consent of both the regulatory authority on the side of the investigation and the Investigator Site on the side of acceptance. Therefore, if you include such a clause in the contract, please limit it to "only when the regulatory authority permits" or, even if you do not include such a clause, please cooperate in the presence of the sponsor when the regulatory authority conducting the investigation permits.
Reason for revision
Since this notice is frequently revised, we have omitted the notice number and other information.