Managing the Trial Master File and basics of Clinical Trial Systems
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 02/10/2025 | Managing the Trial Master File and basics of Clinical Trial Systems | Brussels | EUR 950 | Book |
| If you would like to have this course as an in-house session click here | ||||
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
Course schedule
This training session is organised as a 1-Day classroom: from 09:00 to 17:00Course 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.Programme highlight
- Understand the purpose, importance, and structure of a Trial Master File, including the Investigator Site File
- Know how to apply Good Documentation Practices & perform proper document management
- Performing Quality control and review of a study TMF aiming for inspection readiness
- Understand the basics of commonly used Clinical Trial systems
Learning objectives
- Explain the purpose & structure of a Trial Master File
- Apply Good Documentation Practices, including the ALCOA+ principles
- Provide instructions on how to properly manage documents
- Ensure the quality of a study TMF is acceptable for each inspection
- Have a basic understanding of clinical trial systems
Who should attend
Clinical Trial Assistants/ Clinical Research associates/ Junior Clinical Study Leaders.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (0)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (1)
- Data Management and Informatics (1)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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