Overview
The course introduces the key considerations when designing and conducting a randomised clinical trial. The course is split into two Modules: Module 1 is Trial Design and Module 2 is Trial Conduct. During Module 1, delegates will learn why clinical trials are necessary, how different kinds of trials are designed and how bias can be minimised. Module 2 includes how trials are managed and then analysed, interpreted and reported. Delegates can choose to attend just one Module or both. Neither Module will consider non-randomised trials or other observational designs, or trials evaluating diagnostic tests. We will primarily focus on large multi-centre clinical trials, considering both drug and complex intervention trials.
The course is offered solely online via Microsoft Teams over a 4 week period (2 weeks per Module). During this time, delegates will have access to all course materials, including pre-recorded slides and additional activities. Course materials will be accessible prior to the start of the course date and can be accessed at any point enabling delegates to learn at a time that is convenient to them. Each module comprises a variety of sessions each of which has an organised "live" session with a course tutor. These are organised sessions that all delegates are encouraged to attend, though attendance is not mandatory. You will be notified of live session dates in advance. Live sessions offer delegates an opportunity to talk directly to the course tutor and other delegates, ask questions they may have about the content they've accessed and explore activity content. Although the course is spread over 4 weeks, a lot of content is included. You should therefore ensure you have sufficient time to be able to access pre-recorded materials and attend as many of the live sessions as possible.
Please contact ctu@nottingham.ac.uk if you would like to be added to the mailing list.
Outcomes
By the end of the course, participants should:
Module 1 "Trial Design"
- understand when and why randomised controlled trials are necessary
- understand and evaluate methods to minimise bias in the design and conduct of randomised controlled trials
- be aware of different designs for randomised trials and their use
- be aware what information is required in order to estimate the size of a trial
- be able to participate in the design of a randomised clinical trial
- have an understanding of other methodologies including qualitative and health economics
- understand the importance of Patient and Public Involvement (PPI) throughout the lifecycle of a trial
Module 2 "Trial Conduct"
- understand when and which approvals and regulations are needed in clinical trials
- have an understanding of a clinical trial protocol and other trial documentation
- have an understanding of factors to consider when undertaking a multi-centre clinical trial
- be aware of trial safety and requirements for clinical trials involving medicinal products
- have an understanding of risk assessment, data collection and monitoring of trial data
- know how to report and interpret results from a randomised clinical trial
Is this course for you?
The course is intended for anyone seeking an introductory course on randomised controlled trials, and who is likely to be involved in the design, conduct and management, analysis, reporting or review of clinical trials.
The course will comprise of pre-recorded lectures, other materials and live sessions with course tutors.
I found the course suitable both for novices as well as more experienced managers; it weaves together the essentials of trial management from A-Z, giving a comprehensive overview of all aspects of running a trial whilst supplemented by focussed links to more in-depth information on all subject areas. There is no doubt that completing this course gave me the additional insight and added confidence to secure a post within a trial management team. I highly recommend it!
Course tutors
All sessions on the course will be led by experienced trialists and staff from Nottingham Clinical Trials Unit.
Cost
Early Bird rate :
One Module (either Module 1 or Module 2) £300
Both Modules £450
Standard rate :
One Modules (either Module1 or Module 2) £375
Both Modules £560
What does the course include?
All course materials will be provided by Microsoft Teams. Delegates will be provided with guidance and full joining instructions on how to access the online material and the live sessions with course tutors.
Terms and conditions
In the event that you need to cancel your booking we ask that you give as much notice as possible. Participants cancelling more than two weeks before the start of the course will be eligible for a full refund, after that time you will be charged the full course fee. In the unlikely event that the short course has to be cancelled, our liability is limited to course fees only. If you need to cancel, please email your request to ctu@nottingham.ac.uk
For further information please contact ctu@nottingham.ac.uk or 0115 8231600