Drug Evaluation Committee 2015-37 Necessity of Prescription Preservation
Related classification: Record keeping
Date of first publication: 2016-02
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"?
JPMA's Opinion
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 relevant 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 must be retained as an original document.
Reason for revision
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency), minor changes were made to the description.