Clinical Trials Design
About
This short course is designed to provide students with the ability to critically evaluate clinical trial design, and in depth understanding of patient recruitment and the regulatory and ethical processes involved.
The course will also provide students with the ability to critically appraise clinical trial analysis, reporting and quality assurance.
Research into disease mechanisms and the development of disease diagnostics / therapeutics requires an understanding of clinical trial design including the ethical and regulatory requirements required. This course integrates knowledge of the clinical trials process with patient recruitment.
The aims of this short course are to;
- demonstrate the importance of clinical trials in furthering clinical research.
- develop knowledge on clinical trial design.
- promote understanding of the regulatory requirements for clinical trial running and reporting.
- identify and understand best patient recruitment strategies.
Term dates
Start Date: 27 January 2025 - 6 May 2025.
Attendance
This course is delivered fully online in Semester 2, with no on campus attendance requirements. In addition, students will be required to carry out online research and reading as well as complete assignments.
Location
Delivered fully online.
Assessment
Class Test (Written) [50%]
There will be two multiple choice tests, which will test students on their knowledge of the material covered on research ethics and governance regulatory issues. Each test will last 30 minutes and will be taken online, via Blackboard learn. Each test will be worth 25% of the overall module mark.
Written assignment (Coursework) [50%]
Written assignment (50%): Students will be provided with an example of a clinical trial and they will be asked to critically review this with regards to factors such as trial design and study limitations (2500 words).
Career Options
The short course has particular relevance to;
- Medicine, Pharmacy and Allied Health Professionals.
- Established employees n the pharmaceutical or healthcare sectors who are looking to upskill or learn more about novel and digital trial design.
- Undergraduate or postgraduate students looking for a career in pharmaceutical or healthcare settings.
This short course can significantly benefit potential employees by equipping them with the knowledge and skills necessary for effective and ethical participation in the dynamic field of clinical research. Or indeed train those professionals from Medicine, Pharmacy and Allied Health Professionals who may work or wish to work in the clinical trials area.
A module in clinical trial design and patient recruitment can provide numerous benefits to potential employees in the healthcare and clinical research sectors.
Further Information
Module
This is a 15 credit module short course - see the about section for details of content.
Entry requirements
Academic qualifications
Students will be considered for entry to the course on an individual basis.
The basic entry requirements are outlined below:
Applicants must:
(a) have gained
a second class honours degree or better with significant bioscience (or biostatistics) such as nursing, biomedical sciences, biology, pharmacy from a university of the United Kingdom or the Republic of Ireland, or from a recognised national awarding body, or from an institution of another country which has been recognised as being of an equivalent standard; or an equivalent standard (normally 50%) in a Graduate Diploma, Graduate Certificate, Postgraduate Certificate or Postgraduate Diploma or an approved alternative qualification;
and
(b) provide evidence of competence in written and spoken English (GCSE grade C or equivalent).
In exceptional circumstances, as an alternative to (a) (i) or (a) (ii) and/or (b), where an individual has substantial and significant experiential learning, a portfolio of written evidence demonstrating the meeting of graduate qualities (including subject-specific outcomes, as determined by the Course Committee) may be considered as an alternative entrance route. Evidence used to demonstrate graduate qualities may not be used for exemption against modules within the programme.
Eligibility
Places are limited and open to applicants who:
- are over 18 years of age;
- are eligible to work in Northern Ireland;
- are ‘settled’ in Northern Ireland, and has been ordinarily resident in the UK for at least three years; or
- are a person who has indefinite leave to enter or remain in the UK.
- meet the course specific entry requirements. See course pages for requirements.
- meet the Ulster University general entry requirements
