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.
Structure of CLIC and learning outcomes
CLIC contains several courses and learning activities.
Introduction to ICH-GCP and Introduction to the Conduct of Clinical Trials
The Introduction to the Conduct of Clinical Trials includes six modules:
- Overview of drug development process
- Planning and preparation of a clinical trial
- Patient recruitment and enrollment
- In-trial procedures
- Safety in clinical trials
- Monitoring and auditing
Learning outcome: acquiring basic knowledge.
Basic Course on Clinical Research
The third course, entitled Basic Course on Clinical Research, provides a more in-depth view of:
- The design of clinical trials
- The ethics and regulations of clinical research
- The organization of clinical trials
- The analysis of data and publication
Additional modules
Additional modules on the drug development process, pharmacokinetics, statistics and safety are provided for those who want to acquire the competency of sponsor-investigator.
Learning outcome: understanding the entire process.
Learning activities
The two learning activities include:
- A protocol-based learning module brings the participant through a real protocol to review key concepts in clinical research methodology and key steps in the conduct of the trial.
Learning outcome: applying knowledge to virtual situations.
- An article-based learning module brings the participant through an article of the literature reporting a clinical trial and requests them to make judgements at various critical points in the paper.
Learning outcome: evaluating a real clinical trial.
Learning pathways
The CLIC course can be used in different contexts:
The participant chooses the context according to his/her objectives as well as past experience and training. After completing one context it is still possible to move to an upper one.
In self-learning the participant has access to all the course components and learning activities and uses them freely according to his/her personal needs.
The Level 1 (sub-investigator) context gives access to the Introduction to ICH-GCP and the Introduction to the Conduct of Clinical Trials. The participant has access to a forum to ask questions to the faculty or to post a message.
The Level 2 (investigator) context gives access to the Basic Course on Clinical Research and to the learning activities (protocol-based learning, article-based learning…). The participant has access to a forum to ask questions to the faculty or to post a message.
The Level 3 (sponsor-investigator) context gives access to the additional modules developed by HSeT and PharmaTrain and needed by a sponsor-investigator. This includes a more detailed overview of the drug development process, and modules on statistics, pharmacokinetics and safety. The participant has access to a forum to ask questions to the faculty or to post a message.
A tutor-accompanied learning pathway can be created on demand for groups of participants. A tailored pathway through the various resources is designed according to the specific needs of the participants and is associated with various services : advice of a tutor, possibility to ask e-questions to experts and participation to a discussion forum. Learning activities related to a specific protocol can be created on demand.
Conditions of access
The first course Introduction to ICH-GCP is accessible without charge but requires a registration.
Access to the other courses and learning activities requires a specific registration with a registration fee of 750 €, that includes attendance to a short face-to-face session followed by an examination to obtain a certificate.
Examination and certificate
An examination will be organized at least once a year in Brussels. Depending on the number of participants, additional sessions might be organized in other European cities.
The examination will consist in a multiple choice questionnaire. Three distinct questionnaires will be proposed, corresponding respectively to level 1, 2 or 3 of competency.
Those candidates succeeding the examination will receive a certificate of clinical investigator training. The certificate will mention the level of competency. Last update: Monday, May 30, 2016
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