Addressing the quality challenge of a human biospecimen biobank through the creation of a quality management system.

ABSTRACT:

Background

The objective of the COMET (COllection of MEtabolic Tissues) biobank project is to create a high-quality collection of insulin-sensitive tissues (liver, muscle, adipose tissues, and epiploic artery) and blood sample derivatives (plasma, serum, DNA and RNA), collected from 270 grade 2-3 obese patients undergoing bariatric surgery. Relevant data on patient such as clinical/biological characteristics and sample handling are also collected. For this, our aim was to establish a Quality Management System (QMS) to meet the reliability and quality requirements necessary for its scientific exploitation.

Materials and methods

The COMET QMS includes: (1) Quality Assurance to standardize all stages of the biobanking process, (2) Quality Controls on samples from the first pati

SUBMITTER: Servais MD 

PROVIDER: S-EPMC9803146 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature