Clinical Research (MSc)

This course offers knowledge and expertise relevant to a senior role in clinical research in a pharmaceutical, biotechnology, device, contract research or site management company or the NHS.

This course is designed to advance and enhance a career in Clinical Research in the pharmaceutical industry, health service, contract research organisations, regulatory authorities, data management organisations and in medical writing.

It aims to provide the postgraduate students with an enhanced level of knowledge, understanding and skills in clinical research. It presents an overview of clinical trial processes and the regulations for bringing in a new chemical entity, and it provides an enhanced level of knowledge and understanding of therapeutic areas and their treatments in relation to clinical trials, drug registrations and drug safety

The course is designed to increase the knowledge and skills of the student not only in Clinical Research but also in a diverse range of therapeutic areas. This allows the individual to move confidently between these therapeutic areas and therefore increase their potential value to employers. In the dissertation year, students are encouraged to carry out projects which have direct value to their employer and this potentiates the worth of their studies.

Distinctive features

  • Lecturers from Pharmaceutical Industry provide an up-to-date development in Clinical Research
  • Clinical Research trainers deliver a variety of teaching methods
  • The therapeutic modules widen the skills of the student in an array of medical settings

The diversity of employment backgrounds of participants affords an ideal environment for networking with other clinical research personnel.

Key facts

Next intakeSeptember 2017
Duration3 years
QualificationMSc
ModePart-time - distance learning
Admission Tutor contact(s)

Admissions criteria

Students wishing to enrol on this programme will normally possess an initial degree in the biological or life sciences or a healthcare-related subject awarded by a recognised Institution.

At the discretion of the University, non-graduates with a sufficient qualification (e.g. a nursing qualification) and with relevant experience may also be admitted on to the programme provided you are deemed to be able to demonstrate equivalent skills that are sufficient to meet the demands of the course.

For applicants whose first language is not English, appropriate proof of English skills are required. For IELTS, this will be an overall score of 6.5 with a minimum score of 6.5 for each component.

The programme is studied over 3 calendar years of part-time study and is in a modular format. 

Taught modules are undertaken in the first two years, two in each year. Participants who successfully complete these modules may either receive a Postgraduate Diploma (PGDip) in Clinical Research as an exit award, or progress on to carry out an individual project in the third year for the MSc qualification.

Initial PgDip topics covered in the first two years include:

  • Clinical Research
  • Drug Development
  • Therapeutics of the Respiratory and Central Nervous Systems
  • Advanced Clinical Research
  • Regulatory Affairs
  • Complementary Therapeutics
  • Pharmacovigilance
  • Cardiovascular and Immunological Diseases and Oncology

The MSc is attained through completion of a dissertation in Year 3.

Year one

Two modules (60 credits) at Masters level are studied in this year.

On successful completion of the modules (60 credits), students can opt to receive a Postgraduate Certificate as an Exit Award if they do not wish to pursue their studies further.

Module titleModule codeCredits
Clinical ResearchPHT10130 credits
TherapeuticsPHT10230 credits

Year two

Two modules (60 credits) at Masters level are studied in this year.

On successful completion of the modules in year 1 and year 2 (120 credits), students can opt to receive a Postgraduate Diploma as an Exit Award if they do not wish to pursue their studies further.

Module titleModule codeCredits
Advanced Clinical ResearchPHT20130 credits
Complementary TherapeuticsPHT20230 credits

Year three

A Research Methods Module plus the writing and preparation of an MSc dissertation (60 credits) are undertaken in the third year.

Module titleModule codeCredits
Research MethodsPHT30160 credits
The University is committed to providing a wide range of module options where possible, but please be aware that whilst every effort is made to offer choice this may be limited in certain circumstances. This is due to the fact that some modules have limited numbers of places available, which are allocated on a first-come, first-served basis, while others have minimum student numbers required before they will run, to ensure that an appropriate quality of education can be delivered; some modules require students to have already taken particular subjects, and others are core or required on the programme you are taking. Modules may also be limited due to timetable clashes, and although the University works to minimise disruption to choice, we advise you to seek advice from the relevant School on the module choices available.

How will I be taught?

The course will be taught through a series of lectures and workshops, coursework assignments and course journal preparations aimed at developing transferable skills in critical analysis.

Self-directed study forms an important part of the course, and you will be directed in study skills and guided in the areas for study. You will be expected to manage your own time to undertake significant independent study during the dissertation phase in particular.

 Students are expected to attend all timetabled sessions and are also expected to engage in independent study. Course materials are delivered in our Virtual Learning environment (Learning Central). 

How will I be supported?

  • Initial induction programme for orientation and introducing the programme.
  • Student handbook and Modular programme Guide.
  • Extensive library and other learning resources including IT suites.
  • Excellent teaching facilities, lectures theatres, workshop rooms.
  • All students are allowed a personal tutor whose role is to assist them with personal problems and to advise on pastoral issues.
  • Student e-mail and access to Virtual learning Environment (Learning Central).
  • Electronic access to course speakers
  • Ready access to Course Director.

How will I be assessed?

Knowledge and understanding are assessed both formatively and summatively by written examinations and by performance in course work, practice based course-work assignments, project work and dissertation.

Project work including the design of clinical report forms and other practice based assignments and case studies are assessed from written reports with feedback.  Statistical skills are acquired via didactive methods and tested using practice-based scenarios, likewise in relation to medicines safety and the detection of fraud in clinical research.  Critical appraisal skills are acquired throughout the programme through the interpretation and analysis of published clinical research data.  Production of the dissertation requires a substantive literature review and leads to enhanced written and presentational skills, the dissertation being examined by thesis.

What skills will I practise and develop?

Upon completion of the scheme a typical PGT student will be expected to be able to:

  • Design clinical trial protocols relevant to divergent fields of therapy.
  • Display time and man management skills in clinical projects.
  • Demonstrate awareness of procedures for selection and management of clinical research organisations.
  • Devise and design clinical report forms.
  • Distinguish between statistical methodologies in relation to sample size, randomisation and analysis.
  • Respond to drug safety alerts.
  • Detect and manage fraud in clinical research.
  • Demonstrate communication and report writing skills in the context of differing therapeutic areas.

Display data evaluation and critical analytical skills in the writing of a thesis based on individual research activities.

Knowledge & Understanding:

Enhanced knowledge and understanding are achieved mainly by a student centred learning approach supplemented by review-type lectures, problem solving workshops, tutorials and experiential learning.  

Upon completion of the scheme a typical student will be expected to be able to:

  • Describe the discovery and selection process associated with compounds for human investigation.
  • Understand the principles of pharmacokinetics, pharmacodynamics, and bioequivalence.
  • Understand the crucial concepts of good clinical practice and international harmonisation.
  • Identify the criteria for selection of patients for clinical trials in different therapeutic areas.
  • Demonstrate knowledge of the methods of monitoring drug safety.
  • Demonstrate an enhanced knowledge of therapeutics in identified areas.
  • Comprehend the role of ethics committees and informed consent for clinical research
  • Demonstrate knowledge of the regulatory requirements for Europe, USA and Japan.
  • Discriminate between quality assurance and quality control.
  • Understand the process of audit and regulatory inspection.
  • Understand clinical development programme planning.
  • Understand health economics, pharmacoeconomics and quality of life assessment.
  • Know and understand the principles of data gathering and processing and evaluating it critically in the form of a research thesis.

Intellectual Skills:

Designs of Clinical trial protocols are taught mainly through practice-based assignments and case studies and are assessed with written reports and presentations.  Time and man management skills related to clinical projects are taught didactically with practice-based problem solving exercises undertaken by experts in the field who provide feedback.  Likewise, the rationale for selecting and managing clinical research organisations when outsourcing clinical studies.  

Upon completion of the scheme a typical PGT student will be expected to be able to:

  • Design clinical trial protocols relevant to divergent fields of therapy.
  • Display time and man management skills in clinical projects.
  • Demonstrate awareness of procedures for selection and management of clinical research organisations.
  • Devise and design clinical report forms.
  • Distinguish between statistical methodologies in relation to sample size, randomisation and analysis.
  • Respond to drug safety alerts.
  • Detect and manage fraud in clinical research.
  • Demonstrate communication and report writing skills in the context of differing therapeutic areas.

Display data evaluation and critical analytical skills in the writing of a thesis based on individual research activities.

What are the learning outcomes of this course/programme?

The course is designed to give students the skills and knowledge needed to advance and enhance a career in Clinical Research in the pharmaceutical industry, Health service, contract research organisations, regulatory authorities, data management organisations and in medical writing.

Successful students on this programme will have an advanced standing both clinically and academically, taking them to the forefront of the profession, and enhancing their personal and professional development.

Tuition fees

UK and EU students (2017/18)

Get the latest information on postgraduate fees.

Students from outside the EU (2017/18)

Get the latest information on postgraduate fees.

Will I need any specific equipment to study this course/programme?

You do not need to provide any specific equipment.