Quality Risk Management In Clinical Trials

The purpose of this 1-hour basic training is to facilitate the understanding and implementation of the Quality Risk Management (QRM) to ensure the protection of human subjects and the reliability of clinical trials results.

After completing ths online course you should be able to:

• Understand Quality Risk Management (QRM) principles (which are the key criteria for its success), goals, and how to achieve those goals in the Clinical Research setting.

  
  

• Know how to identify, evaluate, prioritize and control risks according to ICH GCP E6 (R2).

  
  

• Comprehend Risk Management is an iterative process, keeping always in mind that new knowledge and analysis can lead to a revision of the assessed proceses and actions and controls implemented.

The training course consists of automatically narrated video tutorials. Once you complete all the course lectures you will be requested to take an online exam which consists of multiple-choice questions.

Case studies are not part of the training.