Course Description

Deviations and Non-Compliance Handling

Course Description:

This course provides a review of the different types of deviations in regard to patient safety and clinical investigation outcomes. It includes an overview of the necessary steps to correct deviations early-on and to ensure subject safety and data quality. It also gives a general outline of deviation reporting requirements.
The course also covers on what to do if a site is non-compliant with the study requirements and not necessarily related to subject’s participation and points to risk management section of the monitoring plan.

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Ensure early detection of deviations and evaluate their urgency
  • Minimize the occurrence of deviations by implementing the necessary preventive and corrective measures 
  • Apply pre-defined thresholds and ensure appropriate escalation process is understood
  • Optimize overall compliance
  • Secure regulatory compliance through appropriate reporting requirements

Who Should Enroll:

Monitors, investigators, study coordinators, clinical project managers, and regulatory and marketing professionals involved in clinical investigations are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

An understanding of the basics of good clinical practice, medical device regulatory and ethics requirements, and the steps involved in site selection, initiation, and monitoring is required for this course.

Subject Matter Expert:
Danielle Giroud

15 min

Related resources:

Case studies:

Basic Account: € 54.00
Premium Account: € 41.00

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