Drug Evaluation Committee 2015-24 Change of Company Name of Clinical Trial Sponsor
Related classification: clinical trial contracting procedures
Date of first publication: December 2015
Question
The company name of the clinical trial sponsor was changed. At that time, all subjects had already visited the hospital, and the actual company name change took place after all sites had submitted their termination reports, so there were no specific procedures required. The only items we had to deal with were confirming the provision and storage of the sponsor's letter and informing the sponsor that the billing address for the remaining clinical trial expenses would be changed.
What procedures would be required if such a "change in the name of the company requesting the clinical trial" occurred during the implementation of the clinical trial (while the subject was in the hospital)? I have tried to describe our response below. The sponsor's stance is to "read and replace the contract and study protocol that have already been signed.
- If the change of readiness is not possible: Re-conclude the contract. Revision of the clinical trial protocol and other clinical trial documents (facility version, perhaps?)
- Subjects' explanatory document: Depends on the investigator's opinion, but it is not mandatory to revise the explanatory document.
- Clinical trial review committee: Confirms whether or not review is required. (It depends on the clinical trial review committee, but there is no problem to report the change to the committee.
- Company name of the sponsor in the clinical trial documents: The new company name should be used after the company name is changed.
- Are there any other items required under GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the sponsor's company name is changed, we think it is fine as long as there are no obstacles to the distribution of information in conducting the clinical trial and the responsibility for the change is clear.
Therefore, there is no problem in notifying the head of the site and the investigator in writing that the company name has been changed. Although the need for review by the Clinical Trial Review Committee is at the discretion of the head of the site, we do not believe that this is necessarily a matter that needs to be reviewed.
If only the company name is changed, it will not affect the subject's willingness to continue the clinical trial, so it is not necessary to revise the explanatory document. If the explanatory document is not revised, it is acceptable to verbally inform the subject of the company name change and record this in the source documents.