All studies sponsored or co-sponsored by GSTT, KCH (including PRUH), SLaM or KCL (including IoPPN) must be conducted according to this suite of SOPs. For studies hosted by one or more of the partner organisations but sponsored by another organisation you should follow the sponsor’s SOPs, if available, but refer to KHPCTO SOPs for any procedures or processes not otherwise defined.
These SOPs are routinely reviewed and updated as required. All SOPs are controlled documents. The guidance document (below) on version controlling documents, is applicable to all documents produced by the KHPCTO, including but not limited to SOPs, Template documents and Training Presentations. It may also apply to documents produced by Investigator sites, including but not limited to Clinical Trial Protocols, Patient Information Sheets (PIS) and Consent forms and Case Record Forms.
All SOP documents are available as .pdf documents. If you do not have a .pdf reader installed, please follow the link below to download Adobe Reader.
MHRA on gov.uk
From 12th March 2020 to 2nd May 2023, this waiver to the Standard Operating Procedure 2 (Training) extended the required frequency of Good Clinical Practice Training from 2 years to 3 years.
