Lab: Sample Management in Clinical Trials

This Standard Operating Procedure (SOP) describes the management of laboratory samples collected for protocol endpoint analysis in clinical trials. It ensures that sample collection, preparation, storage, transfer, and disposal are carried out in line with the study protocol.

This SOP applies to all clinical trials sponsored, co-sponsored or managed  by King’s Health Partners (KHP)  where samples are collected for protocol endpoint analysis.

Included:

• Samples collected as part of routine clinical care but contributing to trial endpoint analysis.
• Samples collected and managed for study objectives only.
• Samples prepared and stored before shipping to a specialist laboratory.
• Samples collected for exploratory or experimental assays.

Excluded:

• Samples managed solely by local hospital or clinical laboratories as routine standard of care.
• Samples not contributing to protocol endpoint analysis.

Note: Reference ranges and Clinical Pathology Accreditation (CPA, or equivalent) certificates must still be filed in the Trial Master File (TMF).