Consistency: The Secret To Improving Quality And Efficiency In TMF Document Processing

By Cfyn Markwick-Day

Drawing from extensive experience in assisting trial sponsors and Contract Research Organizations (CROs) in implementing best practices for Trial Master Files (TMF), Phlexglobal's experts have repeatedly encountered challenges faced by teams in maintaining data integrity and document quality during the critical document processing phase. This phase, encompassing the steps from obtaining or generating an original document to correctly filing it in the electronic TMF system and preparing it for archiving, presents numerous opportunities for complications within busy study teams.

How can these pitfalls be avoided? Our wealth of experience, gained from processing millions of documents monthly for various clients across multiple eTMF systems, can be distilled into three fundamental principles. First, it is essential to have dedicated, experienced personnel, whether internal, outsourced, or a combination of both, consistently handling document processing. Second, the establishment, implementation, and ongoing maintenance of a uniform process, supported by well-trained personnel, is crucial. Lastly, leveraging technology to reduce manual efforts and errors while reinforcing process consistency is indispensable.

A common thread running through these principles is the emphasis on consistency, which offers various advantages, including reduced time and effort for team members and outsourced providers, fewer errors leading to higher quality and less rework, quicker onboarding for new team members and service providers, and a demonstration of commitment to Good Clinical Practice (GCP) processes and study oversight in the eyes of inspectors.

Learn how by adhering to these principles and ensuring consistency, teams should be better enabled to carry out efficient, high-quality processing of documents.