A good clincial study stands or falls with a good clinical study protocol. 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.
The topics of this one day course range from the basic concepts and content of a study protocol over the regulatory requirements for it up to creating amendments. You will learn who is involved in the protocol development process and what roles are coming into play. Using practical examples and workshop you will learn best practices to match theory with practice. This course focusses on interventional clinical studies.
Course time09h00 - 17h00
Who should attend
Investigators, Medical Writers, Clinical Project Managers and other clinical research professionals with little to no background in the writing of clinical study protocols.
- Fundamentals of the study design
- Content of clinical study protocols
- 'Protocol amendments' and 'protocol administrative changes'
- Tools / suggested practices to improve protocol development
- To get familiar with key aspects of clinical studies
- To become conversant with the content of clinical study protocols
- How can protocol development be more efficient?
- How can you as writer take leadership?