Course Detail

HS025 - GM & Biosafety for Clinical Trials Staff

This 2 hour course will provide an introduction to working safety with biological and genetically modified (GM) agents (i.e. a gene therapy agent) that may be handled by reseawrch nursing, pharmacy and clinical trial associate staff during clinical trials.

Topics will include bio-containment, handling biological/GM waste, disinfection and decontamination, personal protective equipment, transport and storage. Relevant H&S legislation requirements in the context of the management of biological and GM agents in a clinical setting will be covered in conjunction with the principles of risk assessment for hazardous work and infection control practices.


By the end of this course, participants should be able to:

  • • By the end of this course, participants should be able to:
  • • Understand the principles of bio-containment
  • • Know the practical measures required to contain biological / GM agents from start of work through to waste disposal and storage
  • • Be aware of relevant health and safety legislation underpinning clinical trial work with biological & GM agents including risk assessment requirements.
  • • Understand the hazards arising from working with biological / GM agents in a clinical trial setting and risk levels and classification of agents
  • Suitability: For Clinical Research Nurses and Managers, Pharmacy Managers and technicians handling biological/GM agents as part of a clinical trial; Clinical Trial Associates involved in the planning of clinical trials.

Provided by: Health and Safety


Date: Monday 11 February 2019

Venue: RBC Seminar room 4, Robin Brook Centre, West Smithfield

Time: 10:00 - 12:00


  • Dr M Ariyanayagam