This is a short course on the MSc/PGDip Clinical Trials programme. It is available as an optional course on the PGCert when taken alongside the following:
- Rationale for Clinical Trials, Key Concepts and Features
- Preparation and Set-up for a Clinical Trial
It can also be taken on a stand-alone basis.
This short course will provide students with an in-depth understanding of the fundamentals of the project management of trials and the impact of effective and efficient communication with all key players. It will explore the processes which must be implemented to monitor recruitment, data integrity and participant safety. The course will also focus on the regulatory requirements that must be adhered to for different types of ongoing trials, and strategies for the management of non-compliances and amendments to the project plan.
Method of Teaching
The short course involves a variety of teaching methods, including lectures, seminars, tutorials, practical classes/workshops and guided independent study.
On completion, you should be able to:
- Determine the factors that may contribute to the success or failure of a trial project plan and devise a plan which has the flexibility to successfully adapt to change.
- Evaluate the ongoing risks associated with different types of trial and propose risk adaptive techniques to mitigate such risks.
- Plan and deliver a site initiation visit to a multidisciplinary group, with consideration of potential barriers to effective communication.
- Describe the considerations for the ongoing management of open trials and how specific threats to a trial’s successful completion can be minimised.
- Implement appropriate amendments to the project plan in response to unexpected events in compliance with project timelines and regulatory requirements.
- Develop and appraise a plan for the management and validation of trial data.
2 block week of teaching.
15 - 19 January and 29 January – 2 February 2024.
- Oral presentation (40%).
- A 2,500-word extended writing (60%).
Stand Alone Course
Please contact the programme team at firstname.lastname@example.org
Pre-existing knowledge required: completion of Preparation & set-up of clinical trials module or have accessed pre-recorded material OR have experience working within the preparation and set up of trials.
To apply please contact the programme team at email@example.com