Course description
Laboratories handling samples derived from Clinical Trials of Investigational Medicinal Products (CTIMPs) are legally obliged to adhere to Good Clinical Practice (GCP). But what does this mean in practice?
This course will provide a brief overview of CTIMP design and delivery, then guide you through the principles of GCP and what this means from the perspective of the laboratory. Key areas covered include:
- Requirements of a Quality Management System
- Roles and responsibilities
- Participant consent
- Ensuring data integrity
- Managing errors, deviations and incidents
- Archiving
- MHRA inspections
How to book a place
This training is available to staff who work in University of Oxford laboratories handling samples from CTIMPs. To book a place, please contact rgea.training@admin.ox.ac.uk with your work email address and preferred training date.
Format
The course will take place in person at Boundary Brook House, Old Road Campus (location and access details here, please note that visitor parking is not available). It will be delivered by members of RGEA who have previous experience of working in laboratories, and will include some interactive content.
Duration
3 hours, with two short breaks.
Frequency
One session every three months.
Training capacity
The course can accommodate up to 20 people.
We will try our best to book you onto your preferred session. However, if the minimum attendance number is not attained then we will have to cancel the session and move attendees onto the next available session. Likewise, if the training session is fully booked then we will book you onto the next available session.
Dates
Wednesday April 30th 2025, 1-4 pm
Wednesday July 16th 2025, 1-4 pm
Wednesday October 15th 2025, 1-4 pm
NOTE: last date to register is the Monday of the week of the course.
What is needed
The course includes interactive content which requires use of a smart phone. WiFi (Eduroam) is available in Boundary Brook House. Water will be available, and you are welcome to bring your own refreshments.
Provided by
Research Governance, Ethics and Assurance team at the University of Oxford.
