Registration requirements
This registry is a direct implication of the law and is mandatory. Data required to be registered includes all information necessary to guarantee the traceability of the HBM as well as data documenting the sample quality based on (inter)national biobank quality standards. All research projects that make use of HBM have to be included in the registry.
Access
The registry is one central application managed by the biobank which is set up within the PeopleSoft Logistic application on the UZ Leuven network. Access can be granted to both UZ Leuven and non-UZ Leuven researcher and is restricted to those projects (i.e. S-numbers) in which the researcher or any member of his/her study team is directly involved.
To get the data into the Registry, the research project has to be activated and configured in PeopleSoft by the biobank. This requires the study/project to have an S-number. To activate the study/project and gain access to the Registry: complete form Biobank registry access request form (BB-GEN022-FO01) and submit it to wbb@uzleuven.be .
Data entry
Data can be entered directly through the user interface or through a structured import file. Documentation for both, with representative examples, can be found below. Note: To avoid confusion, first read the manual (PR) and examples (AN02) before looking at the import templates (FO01/02) and minimal dataset (AN01). When working with the import template, It is advisable to first encode a representative example of each of the different sample types collected (and/or store) and get this reviewed by the biobank team before continuing to encode all your actual samples
The extent of registration of sample derivatives depends on the intended storage for future use of the derivative. When (part of) the derivative is intended to be kept for future use, it should also be registered at the IN level – and registered OUT when used; whereas when the derivatives are consumed or destroyed after completion of the analysis, it suffices to only register the parent sample IN and OUT of the Registry.
Please note that the PI and his/her team need to maintain traceability of any samples and/or derivatives created from samples that were registered OUT of the biobank registry (e.g. DNA extracted from blood, where blood was registered OUT) to be in compliance with art. 22 of the biobank law. This can be done by means of an (electronic) lab notebook, or other local inventory or sample management systems. The traceability requirement is valid for samples/derivatives that return to the biobank after use as well as for samples/derivatives consumed or discarded at the researcher’s lab after use.