Comparison and Analysis of Two Internationally Recognized Biobanking Standards.

ABSTRACT

Impactful biobanking is underpinned by quality assurance and standardization. Several general biobank standards exist that can be associated with programs to provide different levels of conformity assessment, including the Canadian Tissue Repository Network (CTRNet) Certification program and the International Organization for Standardization (ISO) 20387 and accreditation bodies. We examined the CTRNet Required Operational Practices (2017) and ISO 20387 (2018), to compare them. Although the organization of each standard is different, both describe a set of discrete requirements (elements or subclauses) that comprise the standards that are contained in sections called chapters (CTRNet) or clauses (ISO). The standards have a similar number of requirements (CTRNet 362, ISO 322). To compare these standards, we reclassified the requirements in the ISO standard into 13 categories based on a combination of the chapter headings used in the ISBER and NCI Best Practices that represent important areas of biobanking activity. This categorization of requirements showed that each standard has a different emphasis reflected in different densities of requirements within distinct areas of biobanking. The ISO standard emphasizes Quality Management Systems whereas the CTRNet standard has an even coverage across the full spectrum of biobanking areas, including activities that are relevant to participant enrollment. Nevertheless, ∼60% of the requirements in the CTRNet standard match with those of the ISO standard. We conclude that these two standards have much in common but recommend that individual biobanks consider each standard carefully in the context of the purpose, focus, scale, and scope of their biobank to determine the appropriate standard to be followed.