Drug Evaluation Committee 2014-50 Provision of investigational drug control chart (copy) to sponsor
Related classification: Other
First published: Apr 2015
Revised publication date: Mar 2021
Question
The site would like the sponsor to submit a copy of the chart after the clinical trial is completed for confirmation. Is it possible to refuse?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The sponsor's monitors are responsible for checking the storage and management of investigational drugs (GCP Article 21, Paragraph 1, Guidance 9), and the head of the site is to cooperate with monitoring conducted by the sponsor and provide direct access to all clinical trial-related records (GCP Article 37, Paragraphs 1 and 2 Guidance 1). Therefore, we ask that you cooperate in checking (viewing) the control chart of investigational drug use even during the clinical trial.
In order to ensure proper handling of investigational products, the sponsor must keep records of shipment, receipt, disposal, return and disposal of the delivered investigational products. In addition, each site is obliged to report the quantities of the drugs actually delivered, used, collected, and disposed of in the Notification of Termination of Clinical Trial or Notification of Discontinuation of Clinical Trial. It is stipulated in the "Documents and Records Pertaining to Clinical Trials" (August 31, 2020, Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Drug Evaluation and Control Division) that a copy of the control chart for investigational drugs must be provided to the sponsor while the clinical trial is ongoing. The timing of provision of such documents and records is supposed to be stipulated in advance in the clinical trial protocol or the investigational new drug administration procedure, so we ask for your cooperation in accordance with such agreements. If there is no such agreement, we recommend that you discuss it with the sponsor again.
In ICH-GCP, the sponsor is required to receive a copy of the investigational new drug control chart.
Reference
The ICH-GCP mandatory document for conducting clinical trials "8.4.1 Investigational Product(s) Accountability at Site: Indicates that the investigational product(s) has been used in accordance with the study protocol. Records showing the final quantities of the investigational product(s) received at the site, administered to the subject, returned by the subject, and returned to the sponsor.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15), minor changes were made to the description. In addition, the "Documents and Records Pertaining to Clinical Trials" (July 5, 2027, Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Drug Evaluation and Control Division, Administrative Communication) stipulates that a copy of the investigational drug control chart (currently, investigational drug use control chart) should be provided to the sponsor.