The KHP CTO Quality Team was established in 2008 to manage the Sponsor responsibilities for Clinical Trials of Investigational Medicinal Products (CTIMPs), as defined in the Medicines for Human Use (Clinical Trials) Regulations, for trials sponsored or co-sponsored by King’s Health Partner Organisations. The Quality Team also assist Chief Investigators with the set up and initiation of their trials and to ensure that these trials are established and conducted according to Good Clinical Practice (GCP) and the Regulations.
The Quality Team is led by Amy Holton, Quality Manager, who oversees a team of Clinical Research Associates (CRAs), Clinical Trial Administrators (CTAs), a team of Clinical Trial Trainers and the IT Systems Executive.
A Quality System of Standard Operating Procedures (SOPs) and Policies is in place to ensure compliance with GCP and the Regulations. The CRA team oversee this compliance by working closely with investigator teams and routinely carrying out monitoring visits at investigator sites.
The Trainers ensure that all staff involved in the conduct of clinical trials receive the appropriate training. Details of the courses that we offer can be found here.
Our IT Systems Executive ensures that the Kings Health Partners CTO computer systems and processes used in clinical trials are compliant with the Regulations and GCP. He is also the expert advisor for Investigators wishing to use electronic systems such as eCRFs in their trials and assists and advises Investigators with regards to their trial database requirements.
The Quality Team works closely with our R&D colleagues in the Partner NHS Trusts and with our colleagues in the Trusts’ pharmacy and laboratory departments.
In the first instance all Investigators or Researchers planning to conduct a CTIMP should contact amy.holton@kcl.ac.uk
For trial specific enquiries please contact the CRA team: khpcto.crateam@kcl.ac.uk
