Good clinical practices in the bioanalytical laboratory

Tudan C | Bioanalysis, 15(22), 1381-1388, (2023) Keywords: • audits • clinical • confidentiality • contract research organization • CRO • data integrity • fit-for-purpose • informed consent • protocol • regulatory • sponsor Despite the existence of good clinical practice guidelines, the way in which they are applied to the bioanalytical laboratory remains unclear. Aspects of patient confidentiality, informed consent and subject withdrawal; addressing unblinding associated with sample analysis, including repeat analysis and incurred sample reanalysis; or the differences in responsibilities between the sponsor and contract research organization are not articulated by the US FDA within the bioanalytical setting, and for most bioanalytical laboratories this remains a gap in their standard operating procedures. The aim of this article is...