Sample Management: Recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team

Abstract

The regulations do not contain much guidance on sample management; however this is a very important aspect in regulatory work. A balanced team was formed to discuss the aspects involved and to put forward recommendations. Sampling conditions should be described in the protocol and in the laboratory manual. Items to be described include volume, anticoagulant, protection from light, labelling. The correct procedures for storing the samples at the clinical site and for shipment of the samples are also very important, along with the accompanying information. The chain of custody for the samples must be maintained throughout the complete lifespan of each sample. Therefore storage location and conditions must also be clearly defined at the analytical lab, pre and post analysis. A transparent way to do this is via a LIMS. The storage temperature of the samples must be traceable and controlled, via freezer monitoring. The team suggests to move away from using temperatures to define the storage condition, but rather move to a standard convention of room temperature, refrigerator, freezer and ultra-freeze