MSc Pharmaceutical Technology and Quality Assurance
Year of entry: 2022
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Course unit details:
Clinical Trials for the NHS
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Variable teaching patterns|
|Available as a free choice unit?||No|
This unit engages the learner in a series of activities, learning exercises and reflective materials to provide them with an awareness of the effective management of clinical trials within the NHS research department, clinical trials unit and contract research organisation settings.
It builds upon the learning about the context and requirements for clinical trials in the introductory unit ‘An introduction to clinical trials’ to empower the learner to reflect on the additional challenges that will arise when delivering clinical trials in these particular practice areas.
The unit aims to enable students to:
- Acquire and develop an advanced knowledge and in-depth understanding of the delivery of clinical trials in the specific settings of the NHS and the Clinical Research Organisation/Clinical Trials Unit.
- Acquire and develop the advanced skills to make an effective contribution to managing clinical trials.
- Demonstrate the ability to work in clinical trial practice to ensure the delivery of high quality services that meet national and international regulatory standards.
- Identify their own learning needs, develop themselves as critically reflective practitioners and advance their own learning to sustain continuing professional development, and work at the forefront of clinical trial practice.
- Critically evaluate literature, theories and methodologies and apply regulatory founded approaches to clinical trial delivery.
Teaching and learning methods
Students are provided with the learning material in soft copy form. The learning material comprises 6 chapters covering the key areas to consider when conducting clinical trials for the NHS. Each chapter contains a number of exercises for students to check their learning as they progress through the unit. A reference list of further reading is provided for each chapter allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises and practical demonstrations.
Knowledge and understanding
Students should be able to demonstrate an advanced knowledge and detailed understanding of:
- The history and structure of the NHS and the role the NHS plays in research
- The key national and international regulatory frameworks and legislation with specific reference to clinical trial conduct within which the NHS operates
- The range of clinical trials which may take place within various NHS settings
- The roles of Sponsors, Contract Research Organisations and Clinical Trials Units in clinical trial management
- Study design including protocol development, risk assessment and accurate data capture
- NHS finance, research funding streams and associated processes
- The multidisciplinary and multi-organisational requirements for study set-up and management
- Contractual obligations and responsibilities of key stakeholders
- Management of NHS trials at site, including amendments, data capture, pharmacovigilance, site monitoring and the identification and management of protocol deviations and serious breaches
- The importance of clinical trial project management, budgeting and quality management processes
- How to close trials appropriately and publish results within a non-commercial setting
Students should be able to critically analyse, evaluate and where appropriate formulate an informed opinion about:
- Clinical trial management in the public sector and the differences and challenges compared to private sector clinical trials
- National and international clinical research legislation and how it impacts project delivery in the NHS
- The effectiveness of current systems and processes to streamline clinical trial applications, set-up and management.
- The future of clinical research in the NHS
Students should be able to:
- Analyse qualitative and quantitative data to determine their strength and validity.
- Complete practical exercises to demonstrate an understanding of the application of knowledge derived from the course material
- Engage in critically reflective practice as a process of continuous personal development.
Transferable skills and personal qualities
Students should be able to:
- Critique information from a range of sources to formulate opinions
- Set up and conduct clinical trials in accordance with legislative requirements, demonstrating high level knowledge on a process-driven approach
- Network with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation
- Assess current working practices based on knowledge and experience gained and adapt working processes as necessary
- Prioritise and effectively manage time to complete work by required deadlines
|Written assignment (inc essay)||100%|
Weighting within unit (if relevant)
The student is required to complete a written assignment. Formative assessments are included throughout the text
3000 words (split into 2 x 1500 word assignments)
Each assessment is weighted at 50%
Provisional marks and feedback for coursework returned within 15 working days.
• Health and Social Care Act 2012: Factsheets. In: Health Do, editor. 2012.
• Health Do. The NHS Constitution - the NHS belongs to us all. 2013.
• Gaw A. Trial by Fire: Lessons from the History of Clinical Trials. First edition ed: SA Press; 2009. 100 p.
• Hackshaw A. A Concise Guide to Clinical Trials. First edition ed: John Wiley & Sons; 2009. 226 p.
• (NIHR) NIHR. Clinical Trials Toolkit website [Available from: http://www.ct-toolkit.ac.uk/routemap.
• MHRA. Good Clinical Practice Guide: The Stationery Office; 2012.
|Independent study hours|
|Sue Renn||Unit coordinator|