Drug Evaluation Committee 2011-09 Electronic storage of safety information provided by the sponsor to the investigational sites
Related classification: Record keeping
Initial release date: 2011-07
Revised publication date: December 2021
Question
In the current clinical trials, a great deal of safety information is issued by the sponsor. In addition, because the duration of clinical trials is very long, medical institutions have difficulty in finding a place to store the safety information. Therefore, we are considering sending the first safety information in paper form and storing it electronically. Is there any problem under GCP regarding such a method?
If not, we would like to know if there are any points to keep in mind regarding the method of handling. We would appreciate it if you could provide us with any notices that clearly state specific guidelines.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The handling of cases where electromagnetic records (electronic records, etc.) pertaining to said documents are preserved in lieu of the preservation of documents is stipulated in Article 4 of the "Ministerial Ordinance on the Use of Information and Communications Technology for the Preservation of Documents by Private Business Operators, etc. under the Laws and Regulations of the Ministry of Health, Labor and Welfare (Ordinance of the Ministry of Health, Labor and Welfare No. 44, March 25, 2005)". The GCP-regulated archived documents are also subject to this Ministerial Ordinance.
Therefore, if the above ministerial ordinance is complied with, there is no problem in storing safety information provided by the sponsor in electromagnetic records at the site, but the electromagnetic records must be "authentic," "legible," and "retainable. For these three principles (procedures to be maintained and other points to be noted), it is recommended to refer to the following ministerial ordinances and notifications.
1, "Ministerial Ordinance on the Use of Information and Communication Technology in the Preservation of Documents by Private Business Operators, etc. under the Provisions of Laws and Regulations Governing the Ministry of Health, Labor and Welfare" (March 25, 2005, Ministry of Health, Labor and Welfare Ordinance No. 44)
2, "Guidelines for the Safety Management of Medical Information Systems, Version 5.1" (January 2021, Ministry of Health, Labour and Welfare)
3, "Use of Electromagnetic Records and Electronic Signatures in Applications for Approval or Licensing of Drugs, etc." (April 1, 2005, Pharmaceutical and Food Safety Bureau, No. 0401022)
4, "Basic Policy on the Use of Electromagnetic Records in Clinical Trial Documents" (July 1, 2013, Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau, Evaluation and Management Division, Administrative Communication)
Reason for revision of opinion
4 was added as a related notice.