Trial Master File Workshops

TMF Masterclass

The TMF Masterclass delivers expert coaching and high impact training for experienced professionals to help them take their TMF systems and processes to the next level. For full details of this programme please download a one-page information sheet HERE.

This one-day workshop provides a comprehensive overview of the issues involved in implementing an electronic trial master file. In addition to covering foundation principles such as “what is the trial master file”, this interactive session will provide guidance in a wide range of related aspects, including:

  • What the regulations say about eTMFs – understanding the expectations of regulatory inspectors
  • How documents should be filed in an eTMF – what are the most effective and efficient systems
  • Metadata and naming conventions – how to ensure you can find content quickly and accurately
  • Acceptable document formats
  • How eTMFs can be reviewed by end-users, auditors & inspectors
  • How eTMFs can support global clinical trials
  • How to populate and maintain eTMFs
  • Validation requirements for eTMFs
  • Using e-signatures with eTMFs – what pitfalls to avoid

The interactive workshop takes the form of a combination of classroom-style instruction, discussions and group activities. The day begins at 9:00 am and concludes around 5:00 pm. The material is suitable for a wide range of participants including:

  • Records managers
  • Clinical trial administrators/assistants
  • Clinical team members, including monitors, data managers, medical writers, biostatisticians
  • Technology professionals
  • Clinical development managers

At the conclusion of the day, participants should be able to:

  • Implement practical project planning
  • Recognise the principal regulatory requirements
  • Understand the different approaches to eTMF design
  • Develop useful user requirements for an eTMF
  • Recognise the impact of an eTMF on trial-related processes
  • Evaluate potential eTMF solutions

In addition to our scheduled workshops, we can deliver a course in-house for your company if you have a small group of colleagues who would benefit from this content. The above course outline is a guide only; we are able to customise the content to meet your specific needs if you so wish. Please contact us to discuss scheduling.