Drug Evaluation Committee 2019-29 Record of Whereabouts of Documents and Records Pertaining to Clinical Trials
Related classification: Record keeping
Date of first publication: 09/2019
Question
What specific records are indicated by the following statement in the Appendix to the "Regarding Documents or Records Pertaining to Clinical Trials," an Office Announcement of the Drug Evaluation and Management Division, Pharmaceuticals and Lifestyle Health Bureau, Ministry of Health, Labour and Welfare, dated July 5, 2048? Please explain.
"Personnel involved in the clinical trial shall maintain a record of the whereabouts of each document or record, including source documents."
JPMA Opinion
The administrative contact in your question states that "Documents or records pertaining to a clinical trial may be subject to investigation by regulatory authorities or audits by the sponsor's auditors, etc., and must be organized in such a way as to be able to respond to such investigations. In other words, the sponsor, Investigator Site, etc. are required to prepare records (TMF Index, inventory of materials, etc.) so that it can be grasped at a glance what kind of documents, etc. are being stored and where they are being stored.