Customised In-house Courses are designed for organisations wishing to train a group of your employees at a location of your choice.
Duration:
1 Day
Description
Clinical trials vary widely in design. It is important to understand the design of a trial to be able to effectively review protocols, complete ethics committee submissions, write patient information sheets as well as to design clinical trials. This course provides an essential foundation in clinical trial design and the knowledge needed to be able to design, review and summarise protocols
This course will give delegates:
- the different trial designs
- the considerations needed when designing a trial
- a structure for effective protocol review
- This course is suitable for anyone who is involved in clinical trials.
Who is the course suitable for?
The course has previously been delivered for groups including the following roles:
- CRAs
- CTAs
- Study Nurses
- Investigators
- Data Managers
- Project Managers
- Clinical Trial Coordinators
- Medical Advisers
Example Content
Trial designs
- Parallel
- Cross-over
- Non-comparative
- Challenges and limitations
- Bias
Types of trial
- Objectives
- Difference/superiority trials
- Equivalence
- Non-inferiority
Endpoints
- Definition
- Deciding on
- Good, Bad and the Ugly
Randomisation
- Block Size
- Stratification & minimization
- IVRS
Power and sample size
- Entry criteria
- Patient numbers
- Drop out
- Patient populations
|
