External summary

Background to the discipline and subject, what it is and its place in human endeavour.

Clinical Trials form the evidence base for new treatments and medical interventions. Recent health crises including the COVID-19 pandemic mean that education and training in the design, conduct and implementation of clinical trials has never been more relevant. Equally important is the imperative enshrined in the principles set out in the Declaration of Helsinki to conduct clinical research within a Good Clinical Practice framework that ensures the safety of trial participants and the integrity of trial data. The Clinical Trials programme covers the practical and ethical aspects of clinical trials in order to develop the workforce of the future.

Embedded in the University of Edinburgh Usher Institute, the programme is uniquely placed to tap into the clinical trials expertise that exists in the Edinburgh Bioquarter, a leading global destination for healthcare delivery, groundbreaking medical research and life sciences innovation and entrepreneurship. The co-location of the prestigious Royal Infirmary of Edinburgh teaching hospital, a world-renowned school of medicine, leading medical research institutes and a host of ambitious life sciences companies delivers a formidable network of clinicians, academics, scientists and entrepreneurs. The MSc Clinical Trials programme is in line with the University???s strategic themes and objectives; including influencing globally; leading expertise in data science; creating partnerships with industry and contributing expertise locally. Throughout the programme we reinforce leadership and digital skills in research and learning.

What are the main programme aims (learning outcomes)? 

Educational aims of programme

Our programme aims to provide a high quality, flexible learning environment which will support the demand for appropriately qualified new and existing health professionals who will lead clinical trials. Graduates will gain:

• a critical understanding of the principles, science and evidence underpinning clinical

• ability to critique current approaches in clinical trial design and implementation

• the capacity to take responsibility for their own learning and development within the clinical trials environment

• the ability to communicate the design, implementation and results of clinical trials to a variety of audiences

• the resolve to work professionally and with integrity in a multi-disciplinary research team to deliver effective clinical trials

• the skills to design, implement and report clinical trials

Programme outcomes: Knowledge and understanding

Candidates will gain knowledge and understanding of the key elements and principles of clinical trial design, delivery and analysis and in addition a knowledge and understanding of the principles of GCP and their practical implementation in clinical trials. Our educational aims are outlined above, in the External Summary.

Programme outcomes: Graduate attributes - Skills and abilities in research and enquiry

Graduates of the University will be able to create new knowledge and opportunities for learning through the process of research and enquiry. This may be demonstrated in terms of the following:

• Be able to search for, evaluate, and use the best available evidence in order to design and manage a clinical trial
• Apply a constant and integrated approach to critical analysis, evaluation and synthesis of new and complex ideas, information and issues
• Recognise the relationship between clinical practice and a clinical evidence base
• Understand legal, socio-economic, ethical and cultural issues in the use of information

Programme outcomes: Graduate attributes - Skills and abilities in personal and intellectual autonomy

Graduates of the University will be able to work independently and sustainably, in a way that is informed by openness, curiosity and a desire to meet new challenges. This may be demonstrated in terms of the following:

• Exercise a high level of autonomy and initiative in professional activities
• Be able to make professional decisions based upon the best evidence
• Be open to new ideas, methods and ways of thinking
• Be independent learners who take responsibility for their own learning, and are committed to continuous reflection, self-evaluation and self-improvement

Programme outcomes: Graduate attributes - Skills and abilities in communication

Graduates of the University will recognise and value communication as the tool for negotiating and creating new understanding, collaborating with others, and furthering their own learning. This may be demonstrated in terms of the following:

• Be able to present information clearly in written, visual and oral forms, and communicate ideas and arguments effectively
• Use communication as a tool for explaining, and providing others with adequate information
• Be able to mediate and negotiate with others
• Be able to liaise with different professional groups
• Be able to teach effectively and act as a mentor to others.

Programme outcomes: Graduate attributes - Skills and abilities in personal effectiveness

Graduates of the University will be able to effect change and be responsive to the situations and environments in which they operate. This may be demonstrated in terms of the following:

• Acquire and express attitudes necessary for the achievement of high standards in clinical practice and in personal development
• Understand the professional, ethical and legal responsibilities of working in clinical trials
• Be able to manage risk while working within the limits of their responsibility and capability
• Recognise personal limitations of knowledge and knowing when to seek advice from others
• Know of and respect different cultures, values, views and beliefs
• Build practice on a foundation of universal respect.

Programme outcomes: Technical/practical skills

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Programme structure and features

Degree Type: Postgraduate Taught Masters

Mode of Delivery: Part-time, OLDL

Duration of Study: 36 months

Entry Requirements to year 2: Successful completion of the two core compulsory modules plus one  elective module totalling 60 credits.

Entry Requirements to year 3: Successful completion of the two core compulsory modules plus the necessary elective modules to total 120 credits. 

The MSc comprises 2 core modules (20 credits each) that are taken in the first year of the programme. These are:

1. Introduction to Randomised Controlled Trials and Medical Statistics
2. Ethical and Regulatory Considerations in Clinical Trials

In addition, in the first year of the programme, candidates will also select a further 20 credit elective modules. This allows candidates to tailor their learning to their needs. Please note ??? elective modules are subject to availability.

In year 2, candidates will have the opportunity to select 60 credits from a list of seven 20 credit elective modules.

SQCF credit points and levels for each constituent course and each year of the programme

Core/Optional	Course	Schedule	Level	SQCF Credits
Compulsory	Introduction to Randomised Controlled Trials and Medical Statistics	Year 1 (Sept ??? Dec)	11	20 Credits
Compulsory	Ethical and Regulatory Considerations in Clinical Trials	Year 1 (Jan - April)	11	20 Credits
Optional	Principles of Clinical Trial Management	Years 1 and 2 subject to availability	11	20 Credits
Optional	Clinical Trials in Special Populations	Years 1 and 2 subject to availability	11	20 Credits
Optional	Patient and Public Involvement	Years 1 and 2 subject to availability	11	20 Credits
Optional	Study Design	Years 1 and 2 subject to availability	11	20 Credits
Optional	Monitoring and Audit	Years 1 and 2 subject to availability	11	20 Credits
Optional	Pharmacovigilance	Years 1 and 2 subject to availability	11	20 Credits
Optional	Introduction to Health Economics and Applied Health Economics	Years 1 and 2 subject to availability	11	20 Credits
Compulsory	Masters Dissertation	Year 3	11	60 credits

Year 1 (Certificate): Provides students with the fundamentals of randomised controlled trials, core skills and knowledge covering the principles and frameworks of clinical trials, evidence based medicine, critical thinking and professionalism in relation to the ethical and practical conduct of clinical trials. Candidates who successfully complete the two compulsory core modules plus one elective module are eligible for the award of Certificate in Clinical Trials (60 credits at level 11). 

Year 2 (Diploma): A diverse range of electives relating to trial and quality assurance management, pharma and industry and healthcare are offered, enabling the students to learn and think critically and further develop the intellectual, theoretical and practical skills utilised in the ethical conduct of clinical trials.

Candidates who successfully complete the two compulsory core modules plus a further 80 credits are eligible for the award of Diploma in Clinical Trials (120 credits).   

Year 3 (Masters): Equips students with the skills and knowledge to deliver and communicate a dissertation project, relevant to their current or future career in clinical trials.

Candidates who successfully complete 180 credit points of coursework are eligible for the award of Master of Science in Clinical Trials. This requires successful completion of the core and elective modules in Years 1 and 2 and the completion of a dissertation in Year 3. 

The entire programme is taught at a distance through self-directed learning. It is delivered on an established e-learning platform, which allows candidates easy access to internal and external coursework. Course material includes established texts in electronic format as well as newly commissioned materials. Matriculated candidates have the right to use the extensive electronic resources of the University of Edinburgh, including access to journals, which are regularly reviewed in order to provide the most appropriate and current electronic educational resource. The learning style gives candidates the option of a problem-oriented entry and of systematic learning illustrated through subsequent problem solving. Each candidate will have the support of an e-tutor during each course module, and all candidates have access to online discussion forums. Our online delivery supports the University of Edinburgh???s strategic aims to work sustainably, minimising the requirement for travel and use of print and hard copy resources. We welcome students from all over the world and promote inclusivity by operating flexibility regarding academic entry requirements. We take into account relevant work experience in cases where academic qualifications my not meet our requirements. We promote respect between students and staff in all aspects of online communications ??? our discussion boards provide excellent examples of collaborative working and encourage students to offer and receive support from each other.

Teaching and learning methods and strategies

Module content will be delivered through a mixture of short lectures, pod-casts, webinars, case studies and scenarios and guided reading.  In addition, we will make use of asynchronous discussion boards to enhance knowledge and understanding and help achieve the key learning objectives. 

Because the course content will be delivered entirely via an online platform the learning will be primarily self-directed. 

Assessment methods and strategies

Summative assessment of knowledge and understanding is undertaken through Multiple Choice Questions, Short Essays, Case scenarios, e-Poster submission and the preparation of a dissertation.

Formative assessment is undertaken through non-assessed interim feedback, reflective assignments including blogs, and asynchronous discussion boards. Discussion boards are the principal means of enhancing knowledge and understanding of key learning objectives. Each core module focuses on a specific area of clinical trials and utilises its own discussion board to develop knowledge of current guidelines and developments. Complex discussions are delivered by recognised experts in their field. The interactive nature of the discussions allows constant tutor feedback and allows candidates to modify their thinking based upon the developments of the discussion.

Career opportunities

The programme will offer an alternative to traditional classroom based research training for those candidates who do not wish to take time away from their professional commitments. The course aims to equip candidates with the necessary knowledge and skills to be leaders of clinical trials.  The MSc will supplement and extend a candidate???s undergraduate training and work experience.  It will therefore be an important step towards gaining employment in both the commercial and non-commercial sectors.

The MSc programme is designed to highlight the trainee???s commitment to continual professional development and will ensure a competitive edge when applying for future employment positions.

Roles include:

• Clinical research ??? trial managers, administrators, clinical research associates
• Quality Assurance and Control ??? trial monitors, QA managers, pharmacovigilance
• Data management ??? data managers, biostatistics and programming 
• Regulatory affairs - global regulatory lead, information management associate, executive roles
• Medical affairs ??? Chief and Principal Investigators, medical liaison, medical communications and writing
• Product development ??? medical devices

Other items

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