[Organising an investigation site: a national training reference document]

Area of Science:

• Clinical Research
• Healthcare Management
• Investigator Training

Background:

• Surveys indicate a decline in French investigators' clinical trial performance.
• Insufficient and inconsistent investigator training, alongside suboptimal site organization, contribute to this decline.

Purpose of the Study:

• To address the declining performance of French clinical trial investigators.
• To propose and describe tools for improving study site organization and overall trial conduct.

Main Methods:

• A multidisciplinary working group was formed, comprising experts from academia, industry, regulatory authorities, general practice, and consulting.
• Methods and practical tools were developed to enhance clinical trial site organization.

Main Results:

• The developed tools aim to increase investigators' understanding of their responsibilities and research environment.
• Emphasis is placed on the importance of comprehensive feasibility analysis and active patient recruitment strategies.

Conclusions:

• The implemented tools are designed to bolster site organization and improve the performance of clinical trials.
• These initiatives are expected to enhance the efficiency and effectiveness of clinical research conducted by French investigators.