eTMF Workshop, Heathrow Touchbase Conference Centre, Heathrow, UK
This one-day workshop will provide 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
- How documents should be filed in an eTMF
- Metadata and naming conventions
- 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
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
The workshop fee includes all refreshments, a buffet lunch and printed workshop materials. Accommodation is available at the adjacent Heathrow Premier Inn, rooms from approximately £77.00, excluding breakfast or £99 including 3-course evening meal and breakfast. Free parking is available on site for delegates.
Cost: varies depending on workshop but target price is £500 +VAT
Early-bird discount: We usually offer a 20% discount for early booking
Dates: The workshop is organised on an “as needs basis” i.e. when we have sufficient numbers to justify scheduling a course. Please get in touch if you are interested. We will also deliver a bespoke course for your company; contact us to discuss further.
This event is co-hosted by Rammell Consulting & Phlexglobal
Karen Redding, Global Business Development Director, Phlexglobal
- 19 years experience in Clinical Trial management & support
- Managed large CRO Clinical Department across Europe
- Started successful EDC support division within a CRO
- Leading Phlexglobal’s eTMF initiatives
- Chairing the DIA TMF Reference Model work group
