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 implementing medical institution must prepare a written procedure for operations related to the clinical trial." When the director of the implementing medical institution (director) is replaced, is it necessary for the new director to re-approve the Standard Operating Procedures even if there are no changes in their content?
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 "head of the implementing medical institution" 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 director of the implementing medical institution shall prepare a written procedure for operations related to the clinical trial," but since the preparation of such a written procedure is interpreted to be the responsibility of the director of the implementing medical institution, it is not necessary to re-approve the written procedure 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 Law Concerning Quality, Efficacy and Safety Assurance of Drugs and Medical Devices (Pharmaceutical Affairs Agency Law), as well as changes in the system of the medical institution conducting the study.
Reason for revision
With the enforcement of the Pharmaceutical Affairs Law (November 25, 2014), we have made minor improvements to the description.