Canadian Tissue Repository Network Biobank Certification Program: Update and Review of the Program from 2011 to 2018.

The Canadian Tissue Repository Network (CTRNet) Biobank Certification Program was first launched in 2011 to foster translational research through improved access to high quality biospecimens. This was accomplished by creating and providing biobank education and through the establishment and deployment of common standards to harmonize biospecimen quality and approaches to governance. The CTRNet program comprises registration and certification steps as two linked phases. In the two-step registration phase, the biobank is registered into the system, and an individual completes an overview educational module. In the subsequent certification phase, biobanks undergo a seven-step process, including inviting team members, assigning and completing relevant education modules, uploading documents, and undergoing a documentation audit. As of June 2018, there were 251 biobanks engaged in the CTRNet program, 193 had completed registration, and 40 were fully certified. Over 3/4 of these biobanks completed registration within a week and over 1/3 completed certification within a month. Among registered biobanks, 163 were associated with North American institutions, while 30 were from other international locations, including Australia, Europe, and Asia. The CTRNet program enables biobanks to adopt standards with a flexible approach to accommodate different types of biobanks and a measured investment of effort, creating the foundation for increased access to high quality biospecimens.

Biospecimen Complexity and the Evolution of Biobanks.

Biospecimens are critical in driving health research. There is increased demand for scale and quality of biospecimens that in turn drives biobanking operational costs, influences utilization, and threatens the sustainability of individual biobanks. Biospecimen research has begun to inform the details of new biobanking standards and the steps of the biobanking process that are most important to focus on to achieve higher quality. This focus on quality is currently centered mostly on intrinsic features of biospecimens and their annotating data. This review highlights additional quality features that are important to researchers in determining the fit for purpose in their research. First, we define complex qualities as those that are mostly extrinsic to the individual biospecimen and data, and second, we provide data on the growth in demand for biospecimens with this type of quality in cancer research biobanks. Finally, we discuss why biospecimen complexity is a challenge for biobanks and utilization of existing collections, and provide examples of strategies biobanks can consider to improve their focus on this aspect of quality, as we predict that researcher demand for complex biospecimens will continue to expand in the future.

Is Your Biobank Up to Standards? A Review of the National Canadian Tissue Repository Network Required Operational Practice Standards and the Controlled Documents of a Certified Biobank.

Ongoing quality management is an essential part of biobank operations and the creation of high quality biospecimen resources. Adhering to the standards of a national biobanking network is a way to reduce variability between individual biobank processes, resulting in cross biobank compatibility and more consistent support for health researchers. The Canadian Tissue Repository Network (CTRNet) implemented a set of required operational practices (ROPs) in 2011 and these serve as the standards and basis for the CTRNet biobank certification program. A review of these 13 ROPs covering 314 directives was conducted after 5 years to identify areas for revision and update, leading to changes to 7/314 directives (2.3%). A review of all internal controlled documents (including policies, standard operating procedures and guides, and forms for actions and processes) used by the BC Cancer Agency's Tumor Tissue Repository (BCCA-TTR) to conform to these ROPs was then conducted. Changes were made to 20/106 (19%) of BCCA-TTR documents. We conclude that a substantial fraction of internal controlled documents require updates at regular intervals to accommodate changes in best practices. Reviewing documentation is an essential aspect of keeping up to date with best practices and ensuring the quality of biospecimens and data managed by biobanks.