Guidance on Electronic Acquisition of Clinical Trial Data Supplement

In November 2007, the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association issued a voluntary guidance entitled "Guidance on Electronic Acquisition of Clinical Trial Data" (the "2007 Guidance"). This guidance summarized the requirements for handling data obtained electronically from EDC, which was beginning to be widely used at the time, and from central laboratories, which had not been discussed in a systematic manner. It is no exaggeration to say that it has provided the basis for the sound development of electronic clinical trial data in Japan.
Time has passed, and in recent years, the Electronic Patient Reported Outcomes (ePRO) system, an electronic version of Patient Reported Outcomes (PARO) in which subjects themselves record data, has gradually begun to operate. ePRO In some ePRO systems, data is managed by a contracted development organization, and once stored on a device, the data is sent to the vendor's server without going through the Investigator Site, We have now issued an addendum to the 2007 Guidance to share requirements for handling electronic data that were not addressed in the 2007 Guidance. In conjunction with this, the Supplement also revises some of the issues that were recognized at the time of publication of the 2007 Guidance, namely, the concept of the sponsor's accountability for the identity of electronic data obtained directly from the central laboratories and the source documents of the Investigator Site. The requirements for electronic signatures used in eCRFs were also reviewed from the perspective of regulatory requirements and how they should be operated.
We hope that many people will read this document in order to promote the appropriate digitization of data in clinical trials in Japan.

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