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Comparison and Analysis of Two Internationally Recognized Biobanking Standards
Tamsin Tarling1, Sheila O'Donoghue2,3, Rebecca Barnes3
1Office of Biobank Education and Research, Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Biopreservation and Biobanking
|January 28, 2020
Summary
Quality assurance in biobanking is crucial. This study compares two key standards, ISO 20387 and the Canadian Tissue Repository Network (CTRNet) standards, finding significant overlap but distinct emphases for biobank implementation.
Area of Science:
- Biobanking and Repository Science
- Quality Management Systems
- Biomedical Research Infrastructure
Background:
- Effective biobanking relies on robust quality assurance and standardization.
- Several general biobank standards exist, including the Canadian Tissue Repository Network (CTRNet) Certification program and International Organization for Standardization (ISO) 20387.
Purpose of the Study:
- To compare the requirements of the CTRNet Required Operational Practices (2017) and ISO 20387 (2018).
- To identify similarities, differences, and areas of emphasis within these two major biobanking standards.
Main Methods:
- Comparative analysis of the CTRNet Required Operational Practices (2017) and ISO 20387 (2018).
- Reclassification of ISO 20387 requirements into 13 categories based on established biobanking best practices.
- Quantitative comparison of requirement overlap and density across biobanking areas.
Main Results:
- Both standards contain a similar number of requirements (CTRNet: 362, ISO: 322).
- ISO 20387 emphasizes Quality Management Systems, while CTRNet offers more even coverage across biobanking activities, including participant enrollment.
- ~60% of requirements in the CTRNet standard align with those in the ISO standard.
Conclusions:
- While sharing significant commonalities, ISO 20387 and CTRNet standards exhibit different focuses in biobanking.
- Individual biobanks should carefully evaluate their specific purpose, focus, scale, and scope to select the most appropriate standard for their operations.
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