• A training within the framework of the "Référentiel général de contenu d'une formation à la recherche clinique sur le médicament pour les investigateurs" - published in January 2009 by the Afssaps, LEEM, and AFCROs
• It is a tool at the Investigators’ and Sponsors’ disposal, meant to ensure compliance with the French Good Clinical Practices  

4 teaching modules

1. The regulatory environment; the main definitions of biomedical research
2. The key stages to go through before the beginning of a trial (CPP, Afssaps, CNOM, signing of the protocol, trial set-up, etc.)
3. The procedures throughout the progress of the trial (the Investigator and his staff, consent and information, the vigilance of clinical trials, investigational medicinal products, data collection, etc.)
4. The main steps to take at the end of a trial (publication, archiving, etc.)

These modules deal with the regulatory aspects of chapters 2.1, 2.2, 2.3, 2.4, and 2.6 of the above mentionned Guideline.

A MCQ evaluation (10 questions)

• A minimum score of 8 out of 10 is required to obtain the training certificate; it is possible to redo the MCQ in cases of failure

Concerned public

• Investigators, Investigational staff, CRAs, Study Nurses

Teaching methods

• Training platform accessible via Internet, requiring only a browser (e.g. Internet Explorer, Firefox, Chrome, Safari)
• Three-month access to the training; the training can be carried out in several stages
• Training is in French
• Voice-over comments for each slide
• Complementary documentation, accessible via hypertext links on the slides: 
  • Definitions of terms in a glossary
  • Main regulatory references: articles of the Public Health Code, Good Clinical Practices, etc.

Practical criteria

• Duration: approximately 1 hour (four training modules and a ten-minute multiple-choice quiz)
• Rate: from €200 per attendee (depends on the number of subscribers; taxes not included)

• More information