About the Promotion of DX that Contributes to the Improvement of the Drug Development Environment Joint Statement: Council for the Promotion of Clinical Research at National University Hospitals / Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
As an outcome of the joint meeting held by the Task Force for DX Promotion in Clinical Research of the Council for the Promotion of Clinical Research at National University Hospitals and the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association, a joint statement was issued to express the willingness of both parties to cooperatively promote DX that contributes to improving the drug development environment in Japan, and to discuss the "remote DX" related to clinical trials. SDV", "eConsent", and "Distributed Clinical Trials" concepts related to DX in clinical trials were summarized. In addition, a certain consensus has been reached on the concept of the need for Computerized System Validation (CSV) for remote SDV systems and is incorporated in this document.
Please refer to the following website for the results of the survey on clinical research using digital technology conducted by the Task Force for DX Promotion of Clinical Research of the Council for the Promotion of Clinical Research at National University Hospitals.
We look forward to your continued cooperation in promoting DX.