Our training

Educational Objectives

This training on clinical research and Good Clinical Practices introduces the regulatory framework and ethical rules of clinical research. It also enables participants to understand what a clinical trial entails "in practice" and to be familiar with the roles and obligations of all research stakeholders.

Upon completion of this training, you will receive a certificate that will allow you to demonstrate your knowledge of Good Clinical Practices to various sponsors and meet regulatory requirements.

Training Content

This 100% online training is divided into 6 parts, covering the essentials to know in order to apply Good Clinical Practices.

• In the first part, the foundations and ethical principles will be reviewed, various types of research will be described, the roles of research stakeholders will be specified, and research costs and funding modalities will also be outlined.
• In the second part, the current regulatory framework will be clarified along with the roles of authorities and bodies, the rights of individuals and safety aspects relevant to research, the obligations of sponsors and investigators, and Good Clinical Practices.
• The third part will provide a detailed description of research implementation: from designing a protocol that meets objectives to logistical aspects enabling trial setup, monitoring, and closure.
• In the fourth part, data collection methods specific to the study, particularly those entered in the observation log, will be explained, as well as the procedures for processing this data.
• The fifth part focuses on treatment units, specifically on clinical trials involving drugs. Regulatory aspects will be detailed along with the pathways of experimental drugs.
• Finally, in the last and sixth part, vigilance in clinical trials will be addressed. After clarifying the terminology surrounding clinical trial vigilance, the process of notifications and/or declarations will be explained, specifying the roles and responsibilities of investigators and sponsors.

Target Audience

This training is intended for all personnel working in clinical research and health students.

While a basic scientific background is preferable, regardless of your profile, this comprehensive training will provide you with all the necessary elements for understanding clinical research.

Prerequisites

No prerequisites.

Evaluation Methods

• Multiple-choice questionnaires at the end of each chapter,
• Unlimited attempts, with questions renewed with each new attempt,
• In case of incorrect answers, the correct answers will be displayed along with a justification,
• An average of 80% correct answers across all quizzes is required,
• A training certificate will be issued upon completing all chapters. It is valid for 3 years.

Teaching Methods and Resources

Regulations, case studies, films, examples, and feedback from experiences.

Technical Resources

Audio slideshows, technical and explanatory documentation, glossary, testimonials, and feedback from experiences.