£420 – £480

TMF Workshop (09)

Event Information

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Location

Ibis Styles Hotel

Bickenhill Road

Solihull

B40 1PQ

United Kingdom

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Refund Policy

Refund Policy

No Refunds

Event description

Description

The TMF Workshop 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

The cost for attendance is £350 + VAT for early-bird registrations (up to 25th April) and £400 + VAT for late bookings. VAT is chargeable to all attendees as the training is taking place in the UK. A VAT receipt will be provided automatically following payment.

If you wish to stay at the Ibis Styles Hotel, please contact the hotel directly. The delegate room rate (B&B) is from £68. Other hotels are available nearby.

PLEASE NOTE:

The workshop will be run as scheduled if there are a minimum of five attendees. If fewer than five delegates make bookings, we reserve the right to cancel the event and will make a full refund. The event will not be cancelled later than 13th August however. We advise against making travel/accommodation arrangements prior to 13th August unless you have agreed a refundable rate with your travel/accommodation provider. We will not be held liable for any charges that you may incur due to cancellation. If we achieve the minimum attendance prior to 13th August, we will immediately inform all delegates so that their booking can be confirmed and travel arrangements made.

FAQs

What are my transportation/parking options for getting to and from the event?

The venue is a short taxi ride or 10-minute walk from Birmingham International Railway Station and Birmingham International Airport. The venue has a free car park for workshop delegates.

What's the refund policy?

No refunds are possible once the event has been confirmed (minimum 5 attendees).

Is it ok if the name on my ticket or registration doesn't match the person who attends?

Yes. Your ticket can be used by anyone within your organisation.

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Date and Time

Location

Ibis Styles Hotel

Bickenhill Road

Solihull

B40 1PQ

United Kingdom

View Map

Refund Policy

No Refunds

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