Course for Regulatory Associates in Clinical Trials


Clinical trials are heavily regulated and must be conducted in accordance with standard ethical guidelines, codes of conduct and national laws. This is to ensure participant safety, protection of human rights and privacy, good clinical practice, responsible research conduct, and quality data collection.

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.

This course is appropriate for everyone who wants to start or refresh existing career in Clinical Trials Regulation.

What will I learn?

  • European Clinical Trial Directive – purpose, applicability, guidance documents, protection of vulnerable subjects
  • EUDRACT/EudraVigilance
  • Clinical Trial Regulation No 536/2014 – current regulation situation, transition to the new clinical trial system, centralized review system, new definitions, procedure
  • Form FDA 1572 – purpose, composition, requirements