Learning outcomes

  • The student will know about the primary roles and responsibilities of a Clinical Trial Manager;
  • The student will have learned to identify the key factors that can lead to the failure of a clinical trial and will be able to identify potential solutions to avoid these failures;
  • The student will be aware of the issues and strategies related to research transparency requirements. The student will be able to identify the role(s) of the Clinical Trial Manager in meeting these research transparency requirements.

 

Goals

Enable students to deepen their knowledge of the main aspects of practical clinical trial management.

Content

  1. Factors associated with clinical trials that fails
  2. Project management of randomized clinical trials
  3. False data in clinical trials. 

Exercices

See teaching methods

Assessment method

Preparation + participation to the four discussion sessions (tutorials) (40%)

Production of a written report incorporating a response to all learning objectives. The written report will be organized according to the three main themes covered during the course (60%)

Sources, references and any support material

The various resources needed to meet the learning objectives will be provided to students during class sessions.

Language of instruction

French