This is a one-day training course that would be suitable for anyone with responsibility for establishing or maintaining trial master files. The course covers some of the underlying records management principles such as “what is a record?” and “what is the record life-cycle?” . It then covers the regulatory requirements for the trial master file, including its creation, maintenance and long-term retention, and a detailed review of the TMF Reference Model. We also cover a range of practical issues associated with TMF maintenance. The content is applicable for both paper and electronic trial master files.
The course is usually held at a Training Centre near London’s Heathrow Airport and includes the following programme:
|09:30||Welcome and introductions|
|09:45||Records Management Principles
An overview of records management principles that underpin our responsibilities with regards to creating and managing a trial master file.
|Regulatory and Legal Requirements for a TMF
This session will look at the legal and regulatory requirements pertaining to the trial master file.
|Establishing the Trial Master File
A look at some practical aspects in establishing a TMF, including: document control; organisation and structure; access control; file room requirements; eTMFs, eISFs; change management.
|The TMF Reference Model
Seen by some as the industry de facto standard for a TMF, we will look at the background to the Reference Model, its purpose and benefits, what the Reference Model contains and how the Reference Model can be implemented.
|Establishing the TMF (continued)
Continues from the morning session, including an overview of TMF timeliness, completeness and quality.
|Management and Oversight of the TMF
This session discusses the agency expectations for oversight of the Trial Master File, including quality control and oversight of TMFs maintained by CROs.
Our final session looks at inspector expectations for GCP inspections and includes a summary of inspection findings related to TMFs, including recent critical findings.
Please get in touch for further details.