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Sample Management: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium
Michael J Redrup1, Harue Igarashi2, Jay Schaefgen3
1Quotient Bio Analytical Sciences (an LGC company), Newmarket, UK.
The AAPS Journal
|January 30, 2016
Summary
Proper sample management is crucial for reliable bioanalysis study results. The Global Bioanalysis Consortium (GBC) A5 team developed recommendations covering the entire sample lifecycle, from collection to disposal.
Area of Science:
- Bioanalysis
- Clinical Research
- Laboratory Management
Background:
- Regulated bioanalysis requires robust sample management to prevent compromised study results.
- Current health authority regulations lack specific sample management guidance.
- The Global Bioanalysis Consortium (GBC) formed the A5 team to address this gap.
Purpose of the Study:
- To establish comprehensive recommendations for sample management in regulated bioanalysis.
- To ensure sample integrity throughout the entire sample lifecycle.
- To provide standardized guidelines for health authorities and research institutions.
Main Methods:
- The A5 team convened to discuss and define essential sample management requirements.
- Recommendations were developed covering all stages: collection, processing, storage, shipment, and disposal.
- Emphasis was placed on clear documentation, chain of custody, and standardized storage conditions.
Main Results:
- Recommendations cover protocol-defined sampling procedures, including volume, anticoagulant, light sensitivity, containers, and unique identifiers.
- Documented procedures for sample processing and storage are essential for analyte stability.
- Maintaining chain of custody through paper and electronic systems (e.g., Laboratory Information Management Systems - LIMS) is critical.
- Defined pre- and post-analysis storage locations and conditions, including traceable temperature control.
- Standardized terminology for storage conditions (room temperature, refrigerator, freezer, ultra-freezer) is proposed.
- Documentation of sample disposal at study conclusion is required.
Conclusions:
- Implementing these standardized sample management recommendations is vital for ensuring the reliability and integrity of bioanalytical data.
- These guidelines will support regulatory compliance and improve the quality of clinical and non-clinical studies.
- Adoption of standardized terminology for storage conditions will enhance clarity and consistency across laboratories.