External summary

The Postgraduate Diploma (PG Dip) in Clinical Trials one-year, part-time programme is taught entirely online, and is unique by virtue of its collaboration between the Wellcome Trust Clinical Research Facility and the Edinburgh Clinical Trials Unit. This joint venture aims to deliver a master’s programme to support the demand for appropriately qualified investigators to lead clinical trials of all phases and continue to provide first rate educational training for healthcare professionals through Professional Postgraduate Development.

This vocational PG Dip programme provides the opportunity for healthcare professionals to select those modules relevant to their speciality and area of interest. Candidates will be taught by experienced tutors, all leading experts in their field, and will have access to a large structured learning resource of educational material, including an extensive online library facility.

Educational aims of programme

The overall educational aim of the programme is to provide a high quality, flexible learning environment that will develop new and support existing leaders in clinical trials. Specifically the aims of this programme should allow candidates to:

• Demonstrate understanding and knowledge of the principles of Good Clinical Practice (GCP); ensuring safety of participants and integrity of data in relation to Clinical Trials.
• Demonstrate in-depth understanding of clinical trial design through the translation of pre-clinical data and with a thorough understanding of statistics, ethics and research methodologies
• Plan, write and critique a clinical trials protocol
• Understand the challenges of clinical trial delivery including trial set up, recruitment, follow up and data collection
• Understand the principles of data analysis, dissemination of results and implementation of key findings and thus make informed judgements on new and emerging treatments.
• Understand how specialist knowledge in pharmacology, genetics and imaging is applied to clinical trials.
• Demonstrate awareness of leadership contribution and responsibilities of Chief Investigators, Principal Investigators and research team leaders in the multidisciplinary and multi-site management of 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 section 10.

Because the entire programme is delivered using an online platform, this allows for a range of educational approaches designed to meet the varied learning styles of different candidates. Using a blend of short online lectures, case studies and scenarios, problem-solving and discussion boards; together with directed reading and access to podcasts and archived webinars we will present a coordinated and varied educational programme.

Academic modules (core and elective) explore research methodologies, as well as develop skills which ensure an ability to analyse published evidence and explore interactive and written clinical communication skills.

Summative assessment of knowledge and understanding is undertaken through Multiple Choice Questions, Short Essays, e-Poster submission and the preparation of an e-dissertation. Formative assessment is undertaken through discussion boards and reflective portfolios.

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

PG Dip in Clinical Trials

Degree Type: Postgraduate Taught Diploma

Mode of Delivery: Part-time, OLDL

Duration of Study: 24  months      

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

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

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

• Introduction to Clinical Trials
• Good Clinical Practice, Ethics and Regulatory Issues

In addition candidates will also select a further seven or eight (10 or 20 credit) elective modules from a list of four. This allows candidates to tailor their learning to their needs.

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.

Candidates who successfully complete the two compulsory core modules plus four elective modules are eligible for the award of Certificate in Clinical Trials (60 credits at level 11).  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).  

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.  To ensure that this is effective and efficient all candidates will undertake a compulsory introductory module that will include the principles of online learning skills.

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 an e-dissertation. Formative assessment is undertaken through discussion boards and reflective portfolios.

Years 1-2

A variety of assessment methods will be used.  In each module the relative contributions to the final mark will be as follows:  participation in discussion boards, 40%; Short essay and MCQs, 30%; short reflective account, 10%; and case scenarios, 20%.  Further details of these methods are given below:

Discussion boards

Asynchronous 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.

Short essays and MCQ

Candidates will be asked to produce short pieces of written work (500-1000 words) which will be submitted for marking.  Where appropriate this marking will be done by the candidate’s peers.

Reflective account

After each module candidates are required to complete a written reflective account (800 words) detailing their learning experience.

Case scenarios

Examples of current practice and clinical problems will be used to illustrate and exemplify any abstract concepts presented.  In addition, they will also be used as an assessment tool whereby candidates will be asked to make decisions in real time.

Some assessment will vary depending on existing modules used within the University.

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 PG Dip 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 PG Dip 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.

Other items

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