The Significance of CTA’s in the Clinical Research Process


Clinical trial assistants- or CTA’s- are the glue that holds clinical research together. Handling documentation and data quality standards, CTAs prevent delays and support streamlining the entire clinical research process. In this article, we will explore further the crucial responsibilities of a CTA and give tips on ensuring your CTA can work as efficiently and effectively as possible.


What is a CTA? CTA responsibilities in 2021:

Audit Ready:

The demands of today’s regulatory environment mean that all files must be “audit ready” at all times. One of the key functions of a CTA, therefore, is to ensure consistent audit readiness. This means organizing and filing documents and the master file to prepare particular documents for inspection by regulatory authorities. This issue is crucial to trial success.

Filing Systems:

It’s also crucial that CTA’s develop a consistent and thorough filing system. Regulatory authorities can require documents to be located; after the early stages, files should be archived according to stringent standards.

ICH-Good Clinical Practice (GCP) rules and Good Documentation Practice (GDPR rules) is key. CTA’s are required to stay on top of the demand that this presents.

CTA training

Even the highest quality CTAs need frequent training to stay current on requirements. With the importance of the CTA at the forefront of your mind, you might be considering how to keep on top of CTA training.

Dokumeds are proud to support this, providing internal CTA workshops to bring CTAs from across Europe together. In illustrating how key documents provide the necessary evidence for the investigator and sponsor-regulated activities, they show the importance of the key safeguards for ensuring the data quality standards are met.

Dokumeds focus on teaching the importance of critical thinking alongside practical issues such as setup, maintenance, and quality assurance. Of course, they also show CTA’s how to document and assess quality, record, file, and track trial materials in a CTMS.