Drug Evaluation Committee 2016-05 Preservation of Subject Registration and Investigational Drug Allocation Records
Related classification: Preservation of records
Initial publication date: 06/2016
Revised release date: 04/2024
QUESTION.
In recent Global Clinical Trials, IXRS (IVRS/IWRS) is increasingly being used for subject enrollment and investigational new drug allocation. Both the site and the sponsor receive enrollment and drug allocation notifications by e-mail, and the sponsor has instructed us that we need to save the typing of these e-mails as required documents.
We wondered if there is a need to go to the trouble of typing out and storing the electronic (e-mail) documents as mandatory documents.
Opinion of the Pharmaceutical Cooperative Association
Records showing the process of subject enrollment and investigational drug allocation need to be kept as records (source documents) necessary to reproduce the factual course of a clinical trial. When these records are received by e-mail, the receiving party needs to determine how to preserve the records, and we believe that preserving the e-mail transmissions is one way to do this.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) has published the "Standard Operating Procedures for Electromagnetic Clinical Trial Procedures for Medical Institutions" and other documents as a way to implement clinical trial procedures using electromagnetic records *1 and in this procedure, "5.5 Delivery and receipt of electromagnetic records (2) When e-mails are used 2) When receiving As a record for verifying the factual process, the received e-mail and the received reply e-mail shall be preserved or a receipt book shall be prepared, and the recipient, the date of receipt, and the contents of the receipt shall be recorded. In the case of proxy receipt, the original recipient shall be notified immediately, and a record shall be kept so that the original recipient can verify the factual course of events as confirmed by the original recipient. This is the procedure to be followed.
In this case, the sponsor requested that the typing of the e-mail be saved as a required document, but the method of storing received e-mails varies depending on the situation at each site, including saving the typing of received e-mails, creating and storing a receipt log (recording the recipient, date received, contents received, etc.), and saving received e-mails in electromagnetic form (if received e-mails are stored in electromagnetic form). (In the case of electromagnetic storage, authenticity, readability, and preservation must be ensured in accordance with the Japanese ER/ES guidelines.