Drug Evaluation Committee Consideration of computerized system validation when a sponsor builds a DCT system based on the eConsent system
Electronic Standard for Medical Information Expert Committee
Distributed clinical trials (DCT) are considered important in promoting patient-centered clinical trials, but consideration of computerized system validation (CSV) of systems used for DCT has not progressed.
Electronic Standard for Medical Information Expert CommitteeTask Force 4 discussed CSV of DCT systems using eConsent (electronic consent acquisition) systems as a subject.
We hope that this document will help to advance the consideration of DCT systems in each company and promote DCT.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee Task Force 4