Designing clinical research protocols for a better outcome
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| Date | Product | Location | Price | |
|---|---|---|---|---|
| 01/10/2025 | Designing Clinical Research Protocols for a better outcome | Brussels | EUR 975 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
A good clinical study stands or falls with a good clinical study design & protocol. This was clearly shown in a recent survey that indicated that on average 3.15 protocol amendments are needed for every phase II & III trial.A protocol might be of high scientific value and might look perfect from a theoretical point of view. But when you bring it to the clinic, this is often when things start to get wrong.Are you involved in the development, evaluation, or implementation of clinical study protocols? This course is a good starting point for you then.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- Part 1: Webinar: 2 hours
- Part 2: Face-to-face session: 09:00 - 17:00
The topics of this course are divided into 2 parts:
- The online part will cover the theoretical background and requirements for a clinical study protocol.
- In the classroom part, the practical aspects and cases will be discussed, including existing regulatory requirements and support. Here you will learn how important it is to have a decent study design, based on sound feasibility. You will also learn all stakeholders involved in protocol development, yes also patients! Using practical examples and workshops you will learn best practices to match theory with practice. This course focuses on interventional clinical studies.
Programme highlight
- Fundamentals of the study design
- Content of clinical study protocols
- ‘Protocol amendments’ and ‘protocol administrative changes’
- Involving all stakeholders in designing your study protocol
- Tools/suggested practices to improve protocol development.
Learning objectives
- To get familiar with requirements for a clinical study protocol
- To understand the importance of a good study design, based on sound feasibility
- Learn how protocol development can be more efficient, involving all stakeholders
Who should attend
Investigators, Medical writers, Clinical Project Managers, Clinical Development Leaders and other Clinical research professionals with little to no background in the writing of clinical study protocols.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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