Drug Evaluation Committee 2015-37 Necessity of Prescription Preservation
Related classification: Record keeping
First published date: Feb 2016
Revised publication date: Mar 2021
Question
In one clinical trial, we were told that "prescriptions are source documents and should be kept for 15 years." The sponsor is discussing whether or not the prescription is an original source document in the clinical trial. I am not sure how I should read the section 8.3.13 Sorce Documents in ICH-GCP as the basis for treating prescriptions as source documents. Is it stipulated in ICH-GCP and J-GCP that "the prescription is the source document"?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Source documents are "information related to the factual course of a clinical trial and documents that form the basis of case reports, etc." and source data are "those necessary to reproduce and evaluate the factual course of a clinical trial. (GCP Article 2 Guidance 6 and GCP Article 2 Guidance 18 (12)). In addition, ICH-GCP 8.3.13 states that the source documents are "original documents related to the treatment. That is, the source document must be the first record of the original data (original/original), and a transcribed document based on that record is inappropriate as a source document.
If the prescription corresponds to the document in which the investigator, etc. first recorded the prescription of the investigational drug, concomitant drug, etc. to the subject, it should be kept as an original document.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020), minor changes have been made to the description.