MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details
Year of entry: 2020
Course unit details:
Setting up and running Clinical Trials
|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 covers the basics of planning, setting up and running clinical trials to current standards of Good Clinical Practice (GCP) and provides practical guidance on clinical trial design, protocol preparation, CRF design, monitoring and project management.
- To provide a clear understanding of the regulations, theory and practice of doing clinical trials.
Teaching and learning methods
The unit itself contains quite a lot of information. The student is directed to other sources of information by hyperlinks or references (Essential and Recommended). The bulk of the work will be working through the reading plus completion of the recommended exercises.
The exercises are aligned with the sort of tasks commonly undertaken by those involved in designing and running clinical trials. The recommended exercises will not be marked and are for learning purposes only, and do not need to be submitted. In contrast, the assignment at the end of the module will need to be submitted on time and will be marked along with the exam paper.
Knowledge and understanding
- To provide a background understanding of the regulatory framework for clinical research.
- To provide a basic understanding of the theory of experimental design and how it applies to clinical trials.
- To provide a theoretical understanding and practical guidance on ethics, trial design, protocol writing CRF design and site selection.
- To provide insight into the importance of project management, budgeting, quality management and safety monitoring.
To provide practical guidance on setting up, managing, monitoring and closing clinical trial sites.
|Written assignment (inc essay)||30%|
Provisional marks and feedback for coursework returned within 15 working days.
Exam marks and final marks returned after ratification at exam board.
Di Giovanna and Hayes (2001) Principles of Clinical Research, Wrightson Biomedical Publishing Ltd Petersfield UK and Philadelphia USA
Machin, Day and Green (2004) Textbook of Clinical Trials, John Wiley and Sons Chichester
Good Clinical Practice Guide MHRA 2012
Kolman , Meng and Scott (1998) Good Clinical Practice- Standard Operating Procedures for Clinical Researchers
John Wiley and Sons, Chichester UK
Fitzpatrick S (2006) Clinical Trial Design ,Edited by Nina Downes. ICR Publishing Marlow UK
Kennedy D ( 2002) CRF Designer, Canary Ltd
Dent (1993) Implementing International Good Practices, Interpharm Press Inc, Buffalo Grove USA
Luscombe and Stonier (2006) Clinical Research Manual, Euromed Communications, Haslemere UK
Meeson J (2005) A Pocket Guide to the EU Directive, ICR Publishing Marlow UK
Spielman K (1991) Conducting Routine Monitoring Visits, Clinical research Educational Series, The Barnett International Education Programme
|Scheduled activity hours|
|Assessment written exam||2|
|Independent study hours|
|Bryan Hurst||Unit coordinator|