Irrespective of the motivations behind transitioning documents and data into an electronic Trial Master File (eTMF) system, this endeavor stands as one of the most formidable challenges confronting study teams. The good news is that there exist established techniques to safeguard data precision and integrity throughout the TMF migration process, thereby reducing compliance risks and conserving valuable time and effort.
In this webinar, Technical Development Director at Phlexglobal John Lazenby imparts several tried-and-true methods, enriched with insights drawn from numerous triumphant TMF migrations, such as:
- Comprehensive migration planning checklists, meticulously designed to capture frequently overlooked yet pivotal details.
- The critical aspects to grasp concerning source and destination systems, as well as filing structures.
- Effective strategies for managing both paper-based and hybrid (combining paper and electronic) data sources.
- Nuances in handling open studies versus closed studies, and adept strategies for addressing scenarios where the two coexist.
- The essential metadata requirements and the growing significance of secondary metadata.
- Proficient management of the often diverse array of source document formats and associated metadata.
- Techniques for seamlessly integrating audit trails, data verification, and reconciliation into the process.
Learn more about how your team can streamline TMF migration efforts by watching the webinar below.