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.
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.
Clinical trial assistants 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.
CTAs 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 training workshops, we bring together CTAs from across Europe. We give participants a complete understanding of the demands of clinical research support.