CTA Workshop


Clinical trial assistants (CTAs) play a crucial role in the clinical research process, and personnel entering clinical research require a great deal of assistance and new information to perform their function. To provide this support, Dokumeds held an internal CTA workshop in Riga this year, which brought together all CTAs from Latvia, Russia, Ukraine, and Poland.

In today’s regulatory environment, files must be “audit ready” at all times. A trial master file contains the essential documents recording 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 consistent system is needed so that documents are easy to locate and provide to the study team as well as to 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. They also assist with periodical reviews of clinical project records for accuracy and completeness in order to remain audit-ready and in compliance with ICH-Good Clinical Practice (GCP) rules and Good Documentation Practice (GDP). Participants gained a practical understanding of how these documents provide evidence for the investigator’s  and sponsor’s regulated activities  and explored the key safeguards for ensuring data quality standards are met. Set-up, maintenance, and quality assurance activities were also discussed, as well as common deficiencies and challenges.

This one-and-a-half day workshop covered the basic regulatory principles underpinning clinical research and provided a practical outline of day-to-day functions. A combination of theory and interactive exercises made this workshop the ideal foundation for a career as a CTA. During the workshop, participants were guided through their role and responsibilities as a clinical trial assistant within the context of the regulations and rules governing clinical trials (GCP, GDP, and others), and they were shown how to document, assess quality, record, file, and track trial materials in a CTMS. Trainees also learned about critical thinking and had the opportunity to practice it during group exercises. They saw the clear benefits of critical thinking when they were able to make better-quality decisions, come up with more innovative solutions, and enjoy faster outcomes.

A big thank you to all the participants for their team spirit and dedication and to our colleagues who helped organize and deliver this interactive workshop!

 

 


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