Policies and procedures

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:

• Application and approvals process for studies in the CRF

• Room booking and the registration of study subjects in the CRF

• Access to ‘LEAP’ for KCL staff and students working in the CRF

• Lone working and personal security

• Management of medical emergencies

• Management of medical and laboratory equipment in the CRF

• Responding to the King's CRF security alarms

• Use of the centrifuges

• Procedure for dealing with biological sample spillage

• Processing, storage and shipment of samples

• Out-of-hours and weekend medical cover for studies conducted in the CRF

• Reference to the King’s Health Partners Clinical Trial Office (KHP CTO) SOPs for trial related procedures in the CRF

• Filming and photography in 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.