Drug Evaluation Committee 2014-15 Preservation of test results and images before consent is obtained
Related classification: Record keeping
Initial release date: 09/2014
Revised release date: Mar 2021
Question
We understand that there are some diagnostic images such as "within 6 months of the date of obtaining consent" or "within 1 year prior to the screening test" that are provided in the selection criteria for participation in clinical trials. If there are previous images prior to that (6 months or 1 year) at the time of obtaining subject's consent, is it correct to recognize that we should store all of them as source documents? Or, is it acceptable to keep only those that meet the criteria for participation in a clinical trial, but not those that are older than that and will be destroyed after the legally stipulated retention period has passed?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Source documents are "documents, data and records that are the source of information on the factual course of a clinical trial, case reports, etc." (GCP Article 2 Guidance 6), so all records necessary to demonstrate that individual subjects met the selection criteria are subject to source documents. Therefore, not only diagnostic images, but also medical records, examination notes, memos, etc. can be considered as source documents, so please specify in advance with the sponsor which records can be considered as source documents and deal with them individually. (Please refer to our previous opinion 2011-03.)
Records that cannot be used as source documents do not need to be kept longer than the legally stipulated period, but please be careful not to destroy source documents by mistake.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.