Are you supporting a clinical team, responsible for filing and/or other administrative tasks? Clinical Trial Assistants (CTAs) have a crucial role to play in the clinical research process. They must adequately maintain all the project’s documentation according to stringent standards. In addition, CTAs 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 will guide you through your responsibilities (GCP and others) and shows you how to document, record, file and archive trial material. It 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 time09h00 - 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.
- ICH-GCP as the basis of Clinical Research
- ICH-GCP essential documents – sponsor and study centre requirements
- Trial Master Files (TMF) and Investigator Files
- To introduce the new Clinical Trial Assistants to drug development
- To clarify the difference between medical care and clinical trials
- To be familiar with the new CTA with ICH-Good Clinical Practice (GCP) rules
- To present the processes of a clinical trial from beginning to end
- To explain the why, when and how of essential study documents