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Quality Risk Management In Clinical Trials

Quality Risk Management In Clinical Trials

Quality Risk Management In Clinical Trials

Getting Started

Quality risk management is a systematic process for the assessment, control, communication and review of risks associated with the planning and conduct of clinical trials and clinical development programmes.

What you'll learn

  • Quality Risk Management principles and methodology applied to clinical development, clinical trials.

  • No prior Quality Risk Management knowledge is necessary to participate in this course.

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.

Who this course is for:
  • This course is for professionals who create and protect value in organizations by managing risks, and anyone who wants to elevate their CQRM knowledge, including but not limited to the following departments: Project Management, Clinical Operations, Clinical Data Management, Statistical Departments, Quality Assurance, Regulatory Affairs, Pharmacovigilance, Information Technology.
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