Managing the Trial Master File and basics of Clinical Trial Systems
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Managing the Trial Master File and basics of Clinical Trial Systems

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25/09/2024Managing the Trial Master File and basics of Clinical Trial SystemsBrusselsEUR 950.00Book
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About this course

Reasons to attend

The course gives you insights into a Trial Master File (TMF), the core of a clinical study. Learn how this study document repository can be read, managed, and controlled to ensure inspection readiness at all times.

In addition, we will introduce the audience to the systems used to manage a TMF and the ones commonly used to manage a clinical trial (CTMS, eCOA, IXRS...) 

What's included?

  • Documents and materials related to this course are included
  • Globally recognised certificates awarded after test completion
  • This course has been granted PharmaTrain Recognition

Course schedule

This training session is organised as a 1-Day classroom: from 09:00 to 17:00

Course Description

The Trial Master File (TMF) tells the story of the study… Do you want to know what the primary endpoint was of the study?

Which sites in India participated? Who was responsible for consenting subjects in the Spanish site? Which subject had a headache on day 6? Which monitor visited the site in Hong Kong and what happened during the visit? Which systems were used during the study? When was the study medication destroyed in Norway? When were the samples sent to the central lab? Was all site staff properly trained? Which sites were audited?...

Everything you need to know about a study can be found in the study’s TMF. 

Learn how to organise and properly manage all study documentation, what a good TMF looks like, how to perform adequate quality controls, and above all how to ensure the TMF and study are inspection ready at all times. 

In addition, the course will introduce systems used in a clinical trial, including a Clinical Trial Management System (CTMS), Interactive Voice/Web Response System (IXRS), electronic Clinical Outcome Assessment (eCOA) tools and other options to digitalize trial activities.  

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