MSc Pharmaceutical Technology and Quality Assurance

Year of entry: 2024

View tabs
View full page

Course unit details:
Clinical Trials for the NHS

Course unit fact file
Unit code	PHAR72090
Credit rating	15
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

Overview

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.

Aims

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

Intellectual skills

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

Practical skills

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

Assessment methods

Method	Weight
Written assignment (inc essay)	100%

Assessment	Length	Weighting
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%

Feedback methods

Provisional marks and feedback for coursework returned within 15 working days.

Study hours

Independent study hours
Independent study	150

Teaching staff

Staff member	Role
Sue Renn	Unit coordinator

Return to course details