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."
(Pharmaceutical Cooperative Opinion)
The contact letter in your question states that "Documents or records pertaining to a clinical trial may be subject to investigations by regulatory authorities or audits by the sponsor's auditors, etc., and should be organized in such a way that they can be used for such investigations. In other words, it requires the preparation of records (TMF Index, inventory of materials, etc.) that enable the sponsor, investigational sites, etc. to grasp at a glance what documents, etc. related to the clinical trial are being stored and where they are stored.