Practical strategies for maintaining a complete, accurate, and inspection-ready Trial Master File. Topics include records processing, QC methods, metadata, reconciliation, and telling the full story of the study.
Hidden TMF Clinical Compliance Risks The Risk Of Inspectable Content Housed Outside the TMF In the fast-paced world of clinical trial compliance, maintaining a robust and compliant Trial Master File (TMF) is essential for inspection readiness clinical trials. Yet, many sponsors inadvertently overlook critical good clinical practice (GCP) documentation. This oversight can create unnecessary stress […]
Clinical Trial Master File Trends from 2024 As we approach 2025, the Clinical Trial Master File (TMF) landscape is undergoing substantial transformations. These are being driven by technological advancements and evolving regulatory requirements. At Just in Time GCP, we work with TMFs of all shapes and sizes, and this year, we have identified several clear […]
TMF Management in Clinical Trials: Ensuring Quality, Compliance, and Oversight Just in Time GCP’s Founder and CEO, Donna Dorozinsky, shared her insights in The Clinical Trial Vanguard article titled The Trial Master File: A Window into the Quality of Any Clinical Study. The article underscores the TMF’s essential role in maintaining compliance, oversight, and data […]