CTRNet Biobank Registration and Certification Program

CTRNet has developed this program to address issues identified by stakeholders relating to assurance and quality in biobanking, including:

  1. Adoption of common standards for biobanking to ensure high and comparable quality across biobanks is now recongized as important by biobanks and researchers
  2. Access to educational resources for new and existing biobanks is neccessary to facilitate adoption of best practice-based standards.
  3. Demonstration of committment by biobanks to standards is needed to foster public confidence that high technical and operational standards are being met.

Why is CTRNet a suitable organization to create a Biobank Registration and Certification Program?

CTRNet is a national tumor biobanking network that is:

  • Representative of a spectrum of tumor banks in 5 provinces
  • Driven by biobankers with many years of experience conducting and supporting translational cancer research across tumor disease sites
  • Tasked by the national Institute of Cancer Research - Canadian Institute of Health Research (ICR-CIHR) to develop tools and frameworks to facilitate biobanking in support of research in Canada


What are the objectives of the CTRNet Biobank Registration and Certification Program?

  1. Equilibrate standards across existing biobanks
  2. Communicate established standards to new biobanks.
  3. Provide a program and educational tools that are applicable to the entire spectrum of biobanks, defined as any collection of human biospecimens and associated data compiled for research purposes.


What is the design of the CTRNet Biobank Registration and Certification Program?

Two sequential, linked but partially independent processes, Registration and Certification.

Registration: Goal is to provide the best practice-based standards and foundational knowledge for these standards, via operational practices documents and an on-line education course. Estimated time to completion is 1-2 hours.

Certification: Goal is to provide information and resources as in the registration phase, but also to assess compliance with the standards. Design encompasses two additional components: guided self-assessment of consistency with best practice-based standards; and external/peer verification that the biobank has undertaken to adapt to and/or comply with the standards. Estimated time to completion is three months.

How long are Registration and Certification valid?
Both registration and certification are valid for the project’s duration, to a maximum of five years. However, both expire immediately if REB approval from the applicable REB(s) is not maintained.

Are there any interim activities once Registration is complete?
No, unless substantial changes occur in the design or operation of the biobank, in which case re-registration should be considered by the registrant. 

Are there any interim activities once Certification is complete?
There will be an annual process involving submission of a brief updated self-assessment by the biobank to identify any substantive changes that impact adherence to ROPs. If substantive changes have been made, the CTRNet Certification Office will re-review the application and re-issue the certificate.

CTRNet Certification Office will notify certified biobanks of all new ROPs.

Wouldn’t accreditation by a national standards organization achieve the same goals as CTRNet Certification?
Currently no biobank accreditation program exists, but the CTRNet Program and a future biobank accreditation program are not mutually exclusive:

  • Pursuit of the creation of a Canadian biobank accreditation norm can proceed and may become worthwhile for some types of biobanks, but may not be easily applicable to other types of biobanks (e.g., small, mono-user biobanks)
  • CTRNet is working to fill the gap in the meantime with a Registration and Certification Program designed to be applicable to all forms of biobanks. 

How does the CTRNet Biobank Certification Program differ from an accreditation approach?

  • Not all biobanks will have the resources to complete an accreditation process, even after a Canadian norm is created.
  • The CTRNet Certification program is intended to be flexible in its scale and so applicable to all types of biobanks, from small/research studies through to complex/institutional biobanks.
  • The CTRNet Certification program emphasis is to provide a communication process and education tools and will certify based on best practices created by the biobanking community/experts (ISBER, NCI, OECD).