Clinical operations course
Designing clinical research protocols for a better outcome
A good clinical study stands or falls with a good clinical study design & protocol.
Dates and booking
Choose your date.
No dates are scheduled right now. Join the waiting list below, ask us about the next session, or ask about an in-house course for your team.
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Who it’s for
Is this course for you?
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.
What you’ll learn
About this course.
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.
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
Programme highlights
- 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.
Your trainer
Your trainer.
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.
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