The Regulations define both the sponsor’s and the Chief Investigators responsibilities during the conduct of clinical trials to ensure patient safety and integrity of trial data at all times. The KHP CTO have developed quality systems and processes to manage and deliver the sponsors responsibilities for trials sponsored or co-sponsored by King’s Health Partner Organisations.
The purpose of this policy is to outline a plan of action to ensure that the Sponsor and Chief Investigator responsibilities for ongoing trials are met throughout a period during which a disease is pandemic and a serious risk to human health or potentially a serious risk to human health leading to a shortage of staff resources.
Policy: Pandemic Contingency Plan (3.92Mb)
MHRA Pandemic Situation Questions & Answers (30Kb)
