Drug Evaluation Committee 2012-31 Direct Access in Preparation for GCP On-site Surveillance
Related classification: clinical trial contracting procedures
Initial release date: November 2012
Revised release date: Mar. 2021
Question
Question 1
After the contract period of a clinical trial has ended (clinical trial termination report completed), we are to undergo a GCP on-site inspection.
In order to respond to the GCP inspection, we receive a request from the sponsor for direct inspection. Do we need to re-sign the confidentiality agreement for the direct inspection from the viewpoint of personal information protection? The clause exists during the contract period, but it is interpreted to be invalid outside of the contract period.
In addition, I have seen " 2009-42 Direct Inspection After Completion of Clinical Trial ".
Question 2
The contract for the clinical trial includes cooperation with investigations by regulatory authorities. Should we extend the contract period for the GCP on-site inspection after the contract period has ended? If we extend the contract, question 1 would also be resolved.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 80-2, Paragraph 10 of the Pharmaceutical Affairs Law, the officers and employees of the sponsor are prohibited from divulging any secrets obtained in the course of their duties in relation to the clinical trial without justifiable reason. Therefore, the sponsor is legally obligated to maintain the confidentiality of the subject regardless of the term of the contract. Therefore, we believe that there is no need to conclude a new contract or extend the term of a clinical trial contract (hereinafter referred to as "conclusion of contract, etc.") for the purpose of protecting personal information. In addition, as an agreement with the sponsor is not mandatory for the acceptance of a GCP on-site investigation, there is no need to conclude an agreement from this perspective as well.
In addition, direct access to source documents, etc., as you mentioned in your question, is different from monitoring and auditing as stipulated in GCP, so we believe that such access should be voluntary based on the agreement of both the sponsor and the investigational site.
Reason for revision of opinion
Minor changes have been made to the description in accordance with the name change from the Pharmaceutical Affairs Law to the Law Concerning Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Products.