CLIC : an online course for clinical investigators and their teams

Background and objective

The Innovative Medicines Initiative Joint Undertaking (IMI JU) is a unique partnership between the European Union and the EFPIA (European Federation of Pharmaceutical Industries and Associations). The aim of IMI is to support the faster discovery and development of better medicines for patients and to enhance Europe’s competitiveness by ensuring that its biopharmaceutical sector remains a dynamic high technology sector. Between 2008 and 2017 IMI JU will support both research and training projects.

Within IMI, the PharmaTrain project intends to provide a comprehensive solution for the complex training needs of integrated drug development. It involves 26 universities and 15 EFPIA companies.

Clinical trials are a key component of the drug development process. The conduct of clinical trials in Europe is subjected to more and more rigorous rules, as witnessed by the European Directives 2001/20/EC on Clinical Trials and 2005/28/EC on Good Clinical Practice. The clinical investigators and their teams play a key role in the conduct of clinical trials and the compliance with Good Clinical Practice. An adequate training is thus an essential stake to maintain and develop clinical research and the entire drug development process in Europe.

In view of the time pressure on clinical investigators e-learning represents an appealing option. Therefore PharmaTrain has created CLIC, a comprehensive e-learning course for clinical investigators and their teams. This course is based partially on materials provided by the following contributors: Pfizer, UCB Pharma, PHARMED, IFAPP (International Federation of Associations of Pharmaceutical Physicians) and HSeT.

CLIC complies with the European Syllabus for Training Clinical Investigators published by The European Science Foundation. It is also consistent with the curriculum contents and learning outcomes defined in the PharmaTrain Manual for modules on Clinical Development of Medicines and Clinical Trials (see Annex).

All clinical investigators and investigative team members need not to reach the same level of competency. Three levels of competency can be distinguished.

• Level 1 : competency expected for members of the investigative team who are involved in the trial conduct operations, such as a sub-investigator.
• Level 2 : competency expected for an investigator, who is responsible for the organization and conduct of the study.
• Level 3 : competency expected for an investigator who takes the initiative of a study and is actively involved in its design (sponsor-investigator).

CLIC offers different contexts of learning to reach these distinct levels of competency.