The Medicines for Human Use (Clinical Trial) Regulations 2004 transposed the EU Clinical Trials Directive into UK legislation, which became effective on the 1st May 2004. An amendment to implement the Good Clinical Practice (GCP) Directive was made to the Regulations which became effective in August 2006 Subsequent amendments have also been made over the past 4 years.
The KHP CTO Quality Team was established in 2008 to manage the Sponsor responsibilities for Clinical Trials of Medicinal Products (CTIMPs), as defined in the Regulations, for trials sponsored or co-sponsored by King’s Health Partner Organisations. Also to facilitate Chief Investigators with the set up and initiation of their trial and to ensure that these trials are conducted according to GCP and the Regulations, throughout the life of the trial.
The Quality Team is led by Jackie Pullen, Quality Manager and comprises a team of Clinical Research Associates (CRAs) including a Clinical Trial Administrator (CTA), a team of Clinical Trial Trainers and an IT Systems Executive.
A Quality System of Standard Operating Procedures (SOPs) and Policies has been introduced to ensure compliance with GCP and the Regulations.
The CRA team ensures compliance by monitoring clinical trials and works very closely with the Chief Investigator team to facilitate the smooth running of the trial.
The Trainers ensure that all staff involved in the conduct of clinical trials have received mandatory training such as - GCP training, specialist training for Chief Investigators such as Pharmacovigilance and Trial Essential documentation and SOP training. Elective training is also organised by the Training Team as required by Investigator groups and researchers.
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 who maintain responsibility for giving Trust R&D approval via the Research Governance Process and with our colleagues in the Trusts’ Clinical Trials Pharmacy Departments.
In the first instance all Investigators or Researchers planning to conduct a CTIMP should contact Jackie.firstname.lastname@example.org