Technical and Operational Best Practices

As medicine evolves, researchers are identifying increasing numbers of molecular analytes that characterize both healthy and medical conditions. Careful identification of the presence and levels of such biomarkers can be crucial in diagnostic and treatment decisions. However, mounting evidence indicates that numerous factors in the handling of biospecimens can affect the detection of molecular analytes in downstream analyses (Moore et al. 2011). Although the specific mission of a biospecimen resource will define its collection and processing procedures, common principles apply to all biospecimen types. The technical and operational recommendations in this section have been developed based on current, published information including regulations, guidelines, or established best practices documents in order to promote biospecimen consistency and quality, and to optimize access to such biospecimens and their associated data.

This section of the Best Practices contains the following topics:

• Organizational Overview of the Biospecimen Resource
• Biospecimen Resource Personnel
• Considerations Related to Planning and Development
• Biospecimen Resource Infrastructure and Space Planning
• Overall Operational Considerations
• Biospecimen Resource Evaluation and Assessment