All clinical trials sponsored by one or more of King’s Health Partners Organisations, or clinical trials where the sponsor responsibilities are managed by the KHP-CTO, where laboratory samples are collected for the purpose of assessing protocol endpoints. These include:
Samples managed by the local hospital or clinical laboratory as per routine standard of care, that do not contribute to protocol endpoint analysis, are outside the scope of this SOP. However, reference ranges and Clinical Pathology Accreditation (or equivalent) certificates will be filed within the trial TMF.
SOP: Sample Management in Clinical Trials (287KB)
Template Temperature Log (55kB)
Template Nitrogen Vessel Storage Log (55kB)
Template Sample Tracking Log (1200kB)
Template Sample Transfer Log (1200kB)
Template Sample Disposal Form (1200kB)
EMA Guidance Document
