Drug Evaluation Committee Shared Roles in Global Clinical Trials Based on a Questionnaire Survey of Clinical Trial Sponsors
Clinical Evaluation Subcommittee
May 2011
In recent years, with the increase of global clinical trials, medical institutions and sponsors have commented that there is a workload unique to global clinical trials, but the differences between ICH-GCP and GCP ordinances are negligible. 2010 TF5 investigated the current status of clinical trial implementation systems in order to resolve practical issues, not regulatory requirements. The 2010 TF5 surveyed the current status of clinical trial implementation systems and summarized the appropriate division of roles between medical institutions and sponsors in global clinical trials, in order to resolve practical issues rather than regulatory requirements. The report is accompanied by a process map as a guide, which includes descriptions to help understand the purpose of the work that has been conducted in recent years, and also appends notes on the differences from domestic clinical trials, regulations, etc. We hope that not only those who are new to international clinical trials, but also experienced medical institutions or sponsors will read this report and find it helpful in considering the appropriate division of roles.
Role Sharing in Global Clinical Trials - Based on a Questionnaire for Sponsors - (1MB)
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