Course Detail

HS025 - GM & Biosafety for Clinical Trials Staff

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

Topics will include bio-containment, handling biological/GM waste, disinfection & decontamination, personal protective equipment, transport and storage. Relevant H&S legislation requirements (risk assessment and regulator notification) 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 and containment / infection control practices.

Duration: 2 hours classroom time plus completion of an online knowledge quiz (open book) on QMPlus in attendee’s own time (approximately 30 min).

Certification: An online completion certificate will be generated upon satisfactory completion (pass mark 80% or greater) of the online knowledge quiz on QMPlus by the attendee. The access details for the online knowledge quiz will be provided by the course tutor at the classroom.

This course is not accredited by any training accreditation body.

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 (QMUL / Barts Health NHS Trust).

Requalification / Refresher: Attend and complete the refresher course once every 3 years. (HS030 Bio Hazards and GM Agents Refresher).

Please check non-attendance policy and possible penalties for non-attendance at

External organisations: Open to attendees from external organisations but please note this course is geared towards QMUL / Barts Health NHS Trust arrangements. There is normally a fee chargeable to other organisations. Please complete the training request form available here email it to

Further Information: If you require any further details please contact the Health & Safety Directorate at


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

  • Identify the hazards arising from working with biological / GM agents in a clinical trial setting, risk levels and classification of agents
  • 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

Provided by: Health and Safety


Date: Tuesday 25 February 2020

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

Time: 10:00 - 12:00


  • Dr M Ariyanayagam