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. The cost that this entails are significant and can in most cases be avoided:
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.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
- eLearning (1st part): 2 hours
- One Day face-to-face training: 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.