Drug Evaluation Committee 2009-18 Omissions and Errors in the Notification of Clinical Trial Results
Related classification: Clinical Trial Review Committee
First published: Jul. 2009
Revised publication date: April 2013
Question
In the Notification of Clinical Trial Review Results, the date of the committee review was omitted from the form and the seal of the hospital director was obtained, and the form was submitted to the sponsor and investigator. Since the reason for the omission is clear, and even if it is a copy, if the review date is written, the content is the same as this document, I think it is unnecessary to replace it. Should I replace it even if there is a mistake? I feel that replacing the information each time would only increase the amount of time and effort required, so I am asking this question in the hope that you can tell me the appropriate method.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the omissions or errors in the Notification of Clinical Trial Results are very minor, such as minor typographical errors and omissions, there is no need to correct them.
- Prepare a revised version of the relevant Notification (both the old and new versions of the Notification of Clinical Trial Review Results are to be retained).
- Issue a separate document to supplement or correct the omissions or errors (to be kept together with the Notification of Clinical Trial Review Results with the omissions or errors).
We believe that the person who has the authority to issue the Notification of Clinical Trial Review Results (the chairman of the Clinical Trial Review Committee) should issue the above revised or supplemental documents and make corrections on the notification form.
When issuing the Notification of Clinical Trial Review Results and other documents related to the clinical trial, please make sure to check the contents of the Notification of Clinical Trial Review Results carefully.
Reason for revision of opinion
With the issuance of the "Uniform Form for Requests for New Clinical Trials" (March 26, 2013, Medical Affairs Bureau, Ministry of Health, Labour and Welfare, Director of Research and Development Promotion Division, Pharmaceutical Affairs Bureau), the use of a correction seal has been removed.