TMF Essentials

The HSRAA Trial Master File (TMF) Essentials training course is suitable for anyone with responsibility for establishing or maintaining trial master files whether in paper or electronic format. The course covers a broad array of topics specific to TMF, from the regulatory requirements for the TMF, ALCOA++ as it applies to TMF, TMF responsibilities, TMF structure, inspection preparedness, regulatory findings, and a wide range of practical issues associated with management of the TMF.

The course is delivered as a series of webinar modules of approximately one-hour duration, each corresponding to the topics listed below. Each module may be booked individually meaning there is no obligation to complete all five modules in one sitting.

Module 1: The Regulatory Environment

Module 2: Establishing the Trial Master File

Module 3: Maintaining the Trial Master File

Module 4: The TMF Reference Model

Module 5: Quality Controls and Inspections

It is possible to pause the recordings and go backwards and forwards to any point during the recording. This means that you do not need to attend the whole webinar at a single sitting.

You will receive a certificate of attendance by automated email within 24hrs of accessing the recorded webinar. HSRAA regrets it is unable to send certificates manually due to a limitation of the webinar software.

Cost and Bookings

Cost per webinar module:

  • HSRAA Members £50
  • Non-members £60

 Cost for complete webinar course (includes a 20% discount):

  • HSRAA Members £200
  • Non-members £240.

To purchase an individual module, please click the relevant module in the list above.

To purchase the complete series, please click HERE.

Please note that

  1. following payment, you will immediately be taken to the webinar recording.  You will also receive a registration confirmation e-mail with a link to enable you to watch the recording at any time up to the stated expiry date of the webinar;
  2. HSRAA is not registered for VAT and so no VAT is charged; and
  3. HSRAA does not have the facility to generate invoices manually or to take offline payments. HSRAA uses third-party booking systems that accept only online payment by credit card or debit card. If you do not have access to a corporate card, please make a payment using your personal card and use your organisation’s standard process for employee reimbursement of expenses i.e. the same process you use to reclaim travel expenses from your organisation.