Drug Evaluation Committee Recommendations on Quality Control Processes for Efficient Implementation of Clinical Trials
Clinical Evaluation Subcommittee
April 2012
Recommendations on Quality Control Processes for Efficient Implementation of Clinical Trials
Aiming at efficient implementation of clinical trials, we have prepared materials to help establish quality control processes from recording in source documents to CRF preparation at medical institutions. We have also added an explanation of ALCOA, which has been the focus of much attention recently. We hope you will make use of these materials.
Recommendations on Quality Control Processes for Efficient Implementation of Clinical Trials (522KB)
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As of December 2023From Recording of Clinical Trial Data to Preparation of Case Report Forms at Medical Institutions
Click here to see the results of a pilot study conducted to determine whether conducting clinical trials using these materials contributes to quality control and clinical trial efficiency at medical institutions (8 medical institutions cooperated, and the results include their impressions of the actual use of these materials).
Results of Pilot Study (1,143KB)
Slides and leaflets were created for educational purposes (from the client to the medical institution, within the client, and within the medical institution) about the source documents.
We summarized procedures and points to keep in mind regarding the recording of clinical trial data, also taking into consideration the concept of ALCOA.
We proposed the division of roles and procedures for accurate and efficient preparation of case report forms.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables