This short course will introduce participants from a broad range of disciplines to the key considerations for planning and delivering clinical trials.
Clinical trials are an exciting type of medical research which bring novel therapies to patients, resulting in improved health outcomes. This is exemplified by the recent response to the COVID-19 pandemic where randomised trials of novel therapies, and later vaccines, led to a substantial reduction in virus associated mortality.
Queen’s University Belfast has established a world-renowned reputation for excellence in clinical trials, and iREACH Health will build upon this by delivering an innovative and globally competitive clinical research ecosystem here in Northern Ireland.
| Duration | 3 months |
| Delivery | On-campus |
| Fees from | £755.60*(See Selection Criteria) |
| Start date | 17 Apr 2024 |
This short course will introduce participants from a broad range of disciplines to the key considerations for planning and delivering clinical trials. The course is intended to be practical, focusing on the information and skills needed to take a study protocol and deliver the trial safely and effectively to participants. You will gain understanding of the regulatory processes involved and how to ensure participant safety and integrity of the trial is upheld. Practical workshops will enable students to interact with leading experts in clinical trial delivery and to learn essential skills required for successful trial protocol delivery.
Importantly, although the emphasis here is on clinical trials, the principles are the same for other types of research, for example observational studies and qualitative research. We hope that you will find the course relevant to your role in clinical trial delivery, and will give you the tools you need to be confident and competent in getting research to patients and participants.
Fees
| England, Scotland, or Wales (GB) | £928.80 |
| EU Other/International | £2122.80 |
| NI/ROI | 755.60*(See Selection Criteria) |
Entry Requirements
Have an Honours degree, or equivalent in a biological sciences or healthcare related subject. If you do not have a degree or equivalent but have at least 3 years' experience in a healthcare setting you can still be considered (see Selection Criteria for full Entry Requirements).
The Programme
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Course Content
- The module is designed to be completed part time over 3 months and should be completed within this time.
- The programme content will be delivered in 8 sessions over 4 full days held in person in the Whitla Medical Building, Queen’s University Belfast. Course dates are 17th April, 1st May, 23rd May and 26th June 2024.
- Attendance at >75% of the teaching sessions is required to successfully complete the module.
- The module will also comprise self-directed learning (approximately 180 hours) from a selection of resources to include reading, e-learning, and other online courses.
Assessment will be comprised of:
- Self-directed learning portfolio (pass/fail)
- MCQ exam (40%)
- Longitudinal reflective exercise (60%) based on trial protocols
Module Handbook
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Outcomes
- To provide participants with foundational knowledge of clinical research delivery, focused on clinical trials.
- To help participants understand research delivery and regulatory infrastructure in Northern Ireland and the wider UK.
- To provide participants with necessary skills required to facilitate the set-up and successful operational delivery of a clinical trial, including screening, eligibility, consent and randomisation.
- To understand the processes involved in effective data collection, trial management and oversight.
- To understand the ethical framework involved in clinical trials, and the steps needed to ensure the safety of trial participants and delivery of the research.
- To foster the acquisition of practical skills required to manage study documentation, data entry and laboratory sample processing.
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Delivery
The programme content will be delivered via eight sessions held over four full days.
Day 1 – Wednesday 17th April, 2024
- Welcome to course, assessment, and general overview of research
- Setting up a Clinical Trial
Day 2 – Wednesday 1st May, 2024
- Collecting and managing data during clinical trials
- Managing the conduct of a trial
Day 3 – Thursday 23rd May, 2024
- Patient screening, eligibility, consent, and randomisation
- Managing risk and reporting adverse events
Day 4 – Wednesday 26th June, 2024
- Introduction to basic laboratory procedures and documentation
- Multiple Choice Examination
**It is essential that applicants review the mandatory workshop dates (17th April, 1st May, 23rd May and 26th June 2024), self-directed learning and assessment requirements to prepare for the time commitment required.
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Selection Criteria
Applicants should have at least one of the following:
- A minimum of an Honours degree, or equivalent in a biological sciences or healthcare related subject.
- At least three years’ experience working in a healthcare-related role.
- Current employment in a healthcare research-related role.
Please note that if a candidate does not have the academic qualifications stated in criterion 1, but can prove they have the relevant experience (criteria 2 or 3), their application will still be considered. A Recognised Experience of Learning (RPEL) form will be made available to them to complete in addition to the online application. In this instance, individuals will be contacted directly. If RPEL is required, please ensure you add all information to your application. The more information provided, the more helpful it is for the admissions process.*EU & International applicants may be eligible, but must be aware of visa implications and follow up as necessary for this part time course.
Spaces available
How to apply
1. It is essential that applicants complete the form fully leaving no sections blank, particularly within the sections requesting information about qualifications and employment history.
2. All relevant qualifications including Undergraduate Degrees, Masters, and/ or any others which may be at an equivalent level. Please ensure that copies/photos of these are uploaded to the Direct Application Portal (DAP) as proof.
Please include the following in the “Additional Information box”
1. Course Title: “Delivering Clinical Trials – from protocol to patient”
2. The reasons for wanting to undertake the course and how your work experience fits within the criteria of the course.
3. Confirmation that you can fully commit to undertaking the course, which will commence on 17 April 2024.
**It is essential that applicants review the mandatory workshop dates (17th April, 1st May, 23rd May and 26th June 2024), self-directed learning and assessment requirements to prepare for the time commitment required.
Application Deadline is Monday 25th March 2024.