Good Clinical Practice for NHS Research Staff

This course is designed to provide an insight to the history and application of relevant regulations and good practice guidance within  human participant and clinical research. Delegates will be introduced to the principles of Research Governance and Good Clinical Practice and will be equipped with skills to ensure good conduct of clinical research. A combination of presentations and interactive workshops will be used.

By the end of the day delegates will:

  • Understand the main differences between research, audit and service evaluation.
  • Be familiar with the regulatory aspects of conducting clinical research.
  • Be familiar with the approvals systems of R&D, Ethics (and the MHRA)
  • Be able to identify adverse affects and the reporting procedures.
  • Understand the importance of maintaining a good site file.
  • Be able to identify ‘essential documents’ and know what to do with them.
  • Be familiar with the processes for monitoring, audits and inspections.
  • Be familiar with the end of study requirements.

Level 2: for experienced personnel who are Chief and/or Principal Investigators or managing human participant or clinical research projects for studies covered by the Department of Health Research Governance Framework.  The Medicines for Human Use Act (clinical trials) 2004 will also be mentioned but this session is not primarily for researchers involved in medical device and/or medicinal products trials; it will also be of benefit to novice clinical research staff who require GCP training.

Presented by: Dr Martina Prude or Dr Lindy Dalen