Biorepository best practices for research and clinical investigations

Abstract

Translational research requires good quality specimens to ensure the integrity of research results. Clinical research must rely not only on quality specimens, but as well on clinical annotation for consistent, accurate and verifiable scientific and clinical outcomes. In laboratory research performed on a specimen by a single investigator, quality control is easily maintained. In a multi-site clinical research network, the numerous steps for biospecimens from procurement through transport, processing, storage and ultimately testing requires strict standardization of operational workflows and procedures. The practices of a central biorepository can inform and contribute to best practices regarding clinical research specimen integrity for multi-site clinical research.

Fig. 1.

Overview of areas covered by Biorepository Best Practices with standards to ensure specimen and data integrity.

Fig. 2.

Monthly report of temperature recordings of a −80 °C cold unit as part of a specimen’s history. Every hour, temperature readings are automatically sent to a server and recorded in the log. The temperature range is set from −86 °C to −70 °C indicated by the red lines. The 24 daily data points were entered for entire months, here for the month of July 2019, showing the temperature history of the specimens stored in this specific unit.