MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details
Year of entry: 2020
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.
- 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
This module is delivered entirely through distance learning. A printed manual consisting of ten chapters is issued to the student on registration and receipt of payment. Each chapter is designed to consist of 10 hours of assessed learning.
Additional learning activities are directed which, together with the assessment, require 50 hours of self directed learning and assessment.
Knowledge and understanding
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
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
- 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
- The ability 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
- Networking with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation
- The ability to assess current working practices based on knowledge and experience gained and adapt working processes as necessary
- The ability to 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.
|Independent study hours|
|Lisa Miles||Unit coordinator|