About the Certification Process
- What is the process?
There are two linked sequential processes - Registration and Certification.
Registration: The first phase in this program. The goal is to provide the best practice-based standards and foundational knowledge for these standards.
- Biobank submits registration form and completes the on-line introductory education module ‘Basics of Biobanking’
- CTRNet provides registration record and links to the best practice-based standards.
Estimated time to completion is 2 - 3 hours.
Certification: The second phase in this program. The goals of this phase are to provide additional education modules based on the biobank type and assess biobank documents to determine if the biobank has adapted to best practice standards.
- Biobank provides additional information which enables the CTRNet Certification Office to categorize the biobank for the purpose of determining which education modules are applicable.
- Biobank submits documentation
- Verification by an objective third party (CTRNet Certification Office) that the biobank has completed education relevant to their biobank and have in place essential biobank documents.
The documents requested will be:
- REB certificate
- SOPs specific to biospecimen collection and storage
- Governance structure
- Acknowledgement declaring commitment to strive to confirm with the best practice-based standards on an ongoing basis
Templates and advice will be provided if documentation is not in place at certification application.
The effort required to complete certification will vary depending on the biobank operational complexity and number of personnel. Most biobanks will require 12 hours over one to three months of intermittent activity spread between various personnel.
- How long is Certification valid?
Certification is valid for the project’s duration, to a maximum of five years. (Some biobank projects are integrated with a research project, typically with a defined duration, while other biobank projects are ongoing). However, both expire immediately if REB approval from the applicable REB(s) is not maintained or withdrawn.
- Are there any other activities once the initial Certification Certificate is issued?
The biobank will be asked on an annual basis to update their biobank information, 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.
- How will my biobank be assessed?
The CTRNet Certification Office will verify that the assigned online education modules have been completed and reviewing specific required documents provided by the biobank.
- Who can I contact to learn more?
If you require additional information, please email firstname.lastname@example.org