The Importance of CTA’s in the Clinical Research Process

December 6, 2020

What are CTAs?

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.

What are a CTA’s responsibilities in 2020?

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:

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.

The demands of periodical reviews:

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).

CTA training

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.

  • We illustrate how key documents provide the evidence necessary for the investigator’s and sponsor’s regulated activities.
  • We explain the key safeguards for ensuring data quality standards are met.
  • We discuss set-up, maintenance, and quality assurance activities as well as common deficiencies and challenges.
  • We show CTA’s how to document, assess quality, record, file, and track trial materials in a CTMS.
  • Our combination of theory and interactive exercises make these workshops the ideal foundation for a career as a CTA.
  • We focus on teaching the importance of critical thinking.

If you want to find out more about our workshops, or being a CTA in clinical research, please get in touch.

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