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Short Course | Medicine

Clinical Trials - from Protocol to Patient (20 CATS)

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This short course will introduce participants from a broad range of disciplines to the key considerations for planning and delivering clinical trials.

Clinical trials 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 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.

Up to 25 fully-funded places are available via the Department for the Economy Skill Up Fund. 

Application Deadline: 4:00pm on Wednesday, 20 November

Duration3 months
DeliveryOn-campus
Fee£
Start date15 Jan 2025

This short course will introduce participants from a broad range of disciplines to the key considerations for planning and delivering clinical trials. This 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.

Fee

Free for up to 25 DfE Funded students£0

Tuition fees and other charges are set by the University and are subject to change.

Entry Requirements

Applicants should 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

  • Course Content
    • The module is designed to be completed part-time over 3 months.
    • The programme content will be delivered over 4 full days held in person in the Whitla Medical Building, Queen’s University Belfast. Course dates are to be confirmed. 
    • 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
  • 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.
  • Delivery

    The programme content will be delivered held over four full days (dates to be confirmed).

    Day 1 

    • Welcome to course, assessment, and general overview of research
    • Setting up a Clinical Trial

    Day 2

    • Collecting and managing data during clinical trials
    • Managing the conduct of a trial

    Day 3 

    • Patient screening, eligibility, consent, and randomisation
    • Managing risk and reporting adverse events

    Day 4 

    • Introduction to basic laboratory procedures and documentation
    • Multiple Choice Examination
  • Selection Criteria

    Applicants should have at least one of the following:   

    1. A minimum of an Honours degree, or equivalent in a biological sciences or healthcare related subject.  
    2. At least three years’ experience working in a healthcare-related role. 
    3. 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.  

    The Department for the Economy Skill Up Fund is open to applicants resident in Northern Ireland only. It is not open to applicants from outside Northern Ireland.

    To be eligible for a fully funded place under this programme you must:

    • over 18 years of age;
    • eligible to work in Northern Ireland;
    • settled in Northern Ireland, and has been ordinarily resident in the UK for at least three years;
    • or is a person who has indefinite leave to enter or remain in the UK
    • Must meet the existing entry requirements for the course. 

    Applicants should indicate on the application form if they want to be considered for DfE funding.  

    Due to high demand you are advised to apply as early as possible.

    We may be able to consider self-funded or employer funded applicants on a case by case basis, as capacity on the individual PGCert programmes allow. Please indicate in your application if you wish to be considered as a self-funded or employer funded applicant.

    *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

Application for admission is made via Queen's Portal and applicants should follow the step-by-step instructions on how to apply 

Several options will be displayed in the DAP and you should choose those listed below.  Please note you will not be able to choose Strategic Management & Leadership in Primary Care at this point:

  • Choose Career – Postgraduate Taught
  • Choose School/Institute – Medicine, Dentistry and Biomedical Sciences
  • Choose Degree – Medicine, Dentistry & Biomedical Sciences (Institutional Credit – Postgraduate Taught)
  • Click – Continue button

Applicants should note: 

  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. 

You also need to include specific text in the Additional Information box

  1. The title of the short course (module) you are applying for: “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 the time required to undertake the course.   

Applicants should indicate on the application form if they want to be considered for DfE funding.  

If you should have any issues in completing this online application you should refer to the Admissions and Access Service (apply@qub.ac.uk)

Application Deadline: 4:00pm on Wednesday, 20 November

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