MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

Course unit details:
Setting up and running Clinical Trials

Unit code PHAR72020
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
Offered by Pharmacy
Available as a free choice unit? No

Overview

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. 

Aims

  • 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.

Intellectual skills

  • To provide insight into the importance of project management, budgeting, quality management and safety monitoring.

Practical skills

  • To provide practical guidance on setting up, managing, monitoring and closing clinical trial sites.

Assessment methods

Method Weight
Written exam 70%
Written assignment (inc essay) 30%

Feedback methods

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

Exam marks and final marks returned after ratification at exam board. 

Recommended reading

ESSENTIAL READING

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

 

RECOMMENDED READING

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

Study hours

Scheduled activity hours
Assessment written exam 2
Independent study hours
Independent study 148

Teaching staff

Staff member Role
Bryan Hurst Unit coordinator

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