The Trial Master File is a window into the study through all phases of drug development. The TMF is comprised of the records that tell the story of your study. It gives evidence that the trial was conducted in alliance with standards of Good Clinical Practice (GCP). This story becomes the cornerstone of inspection readiness. The purpose of a regulatory inspection is to confirm that the study was conducted in compliance with GCP, confirm the integrity of the data, and ensure human subject protection. How do we use the power of the TMF to influence the story of the study?
Just In Time GCP’s Key Takeaways from CDISC EU Interchange
CDISC EU Interchange 2024 has concluded and this year we were offered a treasure trove of insights and innovations. The TMF Reference Model’s inclusion in