Drug Evaluation Committee 2007-36 Necessity of Procedure Manual Reapproval due to Change of Head of Medical Institution
Related classification: Other
First published: 08/2008
Revised publication date: Mar 2021
Question
We have the following questions regarding the Standard Operating Procedures at a medical institution where we are in charge of the secretariat.
Article 36 of the GCP stipulates that "the director of the Investigator Site must prepare a written procedure for operations related to the clinical trial." When the director of the Investigator Site (the Director) is replaced, is it necessary for the new Director to re-approve the Standard Operating Procedures even if there are no changes in the content of the Standard Operating Procedures?
Or is it unnecessary to re-approve the Standard Operating Procedures as long as there are no changes in the content, since the person in the position of "Director of Investigator Site" has approved the Standard Operating Procedures?
Also, if re-approval by the new hospital director is required, should it be handled as a revision even if there are no changes in content?
JPMA's Opinion
Article 36, Paragraph 1 of the GCP stipulates that "the head of the Investigator Site shall prepare written procedures for operations related to the clinical trial." Since the preparation of such written procedures is interpreted to be the responsibility of the head of the Investigator Site, it is not necessary to re-approve the written procedures only because of a change in the director. Therefore, it is not necessary to re-approve the procedure manual solely because of a change in the director.
The contents of the procedure manual should be reviewed as necessary in accordance with revisions to GCP and notices related to the Act on Quality, Efficacy and Safety Assurance of Drugs and Medical Devices (Pharmaceutical Affairs Agency Law), changes in the system of the Investigator Site, and other changes.
Reason for revision
With the enforcement of the Pharmaceutical Affairs Law (November 25, 2014), we have made minor improvements to the description.