Regulatory Courses
Part of a STAR Programme

Are you supporting a clinical team, responsible for filing and/or other administrative tasks? This 2-day course will guide you through your responsibilities (GCP and others) and shows you how to document, record, file and archive trial material.

Clinical Trial Assistants (CTAs) have a crucial role to play in the clinical research process. They must adequately maintain all the project’s documentation, records and files and archive them according to stringent standards. In addition, Clinical Trial Assistants also assist with periodical reviews of the clinical project records for accuracy and completeness in order to remain audit-ready. Personnel entering clinical research for the first time and having less than one year’s experience have a great need for information and assistance in order to perform this function.

This two-day course covers the basics and regulatory principles that underpin clinical research and also provides a practical coverage of the day to day functions. Theory and interactive exercise make this training the ideal foundation for a career as a CTA.

Course time
09h00 - 17h00
Who should attend

Clinical Trial Assistants who are relatively new to the job. This course will also be beneficial to people working in other areas

Programme highlights
  • ICH-GCP as the basis of Clinical Research
  • ICH-GCP essential documents – sponsor and study centre requirements
  • Trial Master Files and Investigator Files
Learning Objectives
  • Introduce the new Clinical Trial Assistants to drug development
  • Clarify the difference between medical care and clinical trials
  • Be familiar with the new CTA with ICH-Good Clinical Practice (GCP) rules
  • Present the processes of a clinical trial from beginning to end
  • Explain the why, when and how of essential study documents



This course covers competencies that are part of theECCRT Competency Framework

  • Scientific Concepts & Research Design (0)
  • Ethical & Participants Safety Considerations (0)
  • Investigational Product Development and Regulation (5)
  • Clinical Studies Operations (GCPs or ISO 14155) (8)
  • Study and Site Management (0)
  • Data Management and Informatics (3)
  • Leadership and Professionalism (1)
  • Communication (0)
  • Teamwork (0)
  • Business acumen (0)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained

Book a course

No session currently available.
In case of interest, please contact us.


Sylviane Hauser
November 2017
Edwards Lifesciences BVBA

It was a very complete course full of good tips and tricks. As I'm new in the job, I did not really know what to expect but I realised that I already do a lot of what Marleen covered. But thanks to Marleen, all the pieces of the puzzle fell into place. Moreover, the course was very interactive with a lot of practical examples from Marleen which is definitely a plus.