All Policies and Standard Operating Procedures (SOPs) for the Experimental Medicine Facility (EMF) and Clinical Trials Facility (CTF) are controlled by our Good Clinical Practice (GCP) Quality Assurance Manager and for the Cell Therapy Unit (CTU) by Good Manufacturing Practice (GMP) Quality Assurance Managers, to ensure robust document management and control, in line with GCP and GMP requirements.
Throughout the King's Clinical Research Facility, Q-Pulse is used to help maintain our Quality Management Systems.
Some of the SOPs and Policies for the EMF and CTF are available below:
- Managing clinical trial visits during COVID-19 Pandemic in the King’s CRF
- Lone Working and Personal Security
- Management of Medical Emergencies
- MRI Access Control and Safety Procedures
- Use of the Centrifuges
- Procedure for Dealing with Biological Sample Spillage
- Processing, Storage and Shipment of Samples
- Safety Reporting and Pharmacovigilance
- Management and Accountability of IMPs
- Policy for Studies with Paediatric Subjects
- Performing Venepuncture in the CRF
- Use of The Over-Volunteering Prevention System (TOPS) at the CRF
Other SOPs and Policies are available from the CRF - please contact us.
The CRF Standard Operating Procedure template should be used for all CRF SOPs, including study-specific SOPs.