Clinical trial assistants (CTAs) play a crucial role in clinical research. From preventing delays through organizing documentation to meeting data quality standards, a CTA’s function is to support the entire research process. Personnel entering the clinical research field, therefore, require a high standard of training and support. They also require access to the most up-to-date information.
Consistently audit ready:
In today’s regulatory environment, files must be “audit ready” at all times. A trial master file contains all of the essential documents that record how a sponsor has fulfilled their obligations for a clinical trial. Regulatory authorities may contact the sponsor to request a particular document for inspection. Therefore, the timely filing and organization of these documents is of the utmost importance.
A stringent filing system:
CTA’s must develop a consistent filing system. Documents must be easy to locate and to provide to the study team or regulatory authorities in a timely manner. Clinical trial assistants must adequately maintain all documentation, records, and files for the project and archive them according to stringent standards.
The demands of periodical reviews:
CTA’s must also assist with periodical reviews of clinical project records. These reviews occur on the grounds of both accuracy and completeness in order to remain in compliance with ICH-Good Clinical Practice (GCP) rules and Good Documentation Practice (GDP).
Staying on top of CTA training can be a challenge and Dokumeds are proud to support this. At our regular internal CTA workshops, we bring together CTAs from across Europe. We give participants a complete understanding of the demands of clinical research support.
If you want to find out more about our workshops, book a call here.