PSIParelsnoer Institute

Contact details:

prof Gerhard Zielhuis,
Academic Medical Center (AMC), Rode Luifel, Secretariat room TKs0-221, Meibergdreef 9 1105 AZ AMSTERDAM ZUIDOOST

In Parelsnoer Institute (PSI) all Dutch UMC’s collaborate and prospectively collect biomaterials and associated data from patients. This unique institute provides a national research infrastructure that is integrated in clinical care procedures. It offers ready to use harmonized procedures in compliance with (inter-) national standards to ensure uniform collections by participating institutions. As such PSI serves as a model for high quality multicentre disease-based biobanking leading to impactful scientific results. PSI constitutes a federation of biobanks. It is funded by the Netherlands Federation of University Medical Centres (NFU) and separate institutions. Currently biobanks concerning 14 diseases are established and accessible for any researcher to do research.

Parelsnoer Institute (PSI) constitutes a federation of biobanks and provides new standards for clinical biobanking
Research with biomaterials allows the detection of biomarkers and associations between genetic factors and diseases. It aims to improve the diagnosis, prevention and treatment of complex disorders and to facilitate personalized medicine. In order to achieve these goals DNA, serum and other biomaterials, stored in biobanks, are needed from large cohorts of clinically documented patients. For many disorders this cannot be realised by one institution alone. Therefore, the Netherlands Federation of University Medical Centres (NFU; UMC’s) established the Parelsnoer Institute (PSI) in 2007. In PSI all Dutch UMC’s collaborate and prospectively collect biomaterials and associated data from patients. This unique institute provides a national research infrastructure that is integrated in clinical care procedures. It offers ready to use harmonized procedures in compliance with (inter-) national standards to ensure uniform collections by participating institutions. As such PSI serves as a model for high quality multicentre disease-based biobanking leading to impactful scientific results.
An outline of the Parelsnoer Institute operations
In the participating institutions clinical researchers collaborate and prospectively collect, store and manage biomaterials and associated (clinical) data from their patients. These researchers choose to exploit the PSI infrastructure and specifically aim to collect these data and materials integrated in hospital care procedures during many years. In this way disease-based collections of biomaterials and data develop, the so-called Pearls. Standard operating procedures (SOP’s) throughout the phases of the biobanking process are developed and implemented to ensure quality and uniformity of the collections. PSI provides a regulatory framework in which legal ethical guidelines, in accordance with (inter-) national legislation and rules, are described. To establish a uniform collection of data a Parelsnoer Repository for information specification modelling and architecture (PRISMA) specifies the core dataset and timeframes for data registration in line with routine care procedures in the participating UMC’s. The biobanking protocol of PSI is a consensus agreement on the SOPs throughout the subsequent phases of biobanking. A national team of PSI experts and advisors supports the researchers and board in the establishment and implementation of standards and procedures. For instance on subjects like - legal and ethical issues- processing biomaterials - information models for clinical data - infrastructure - quality control at all levels - release of data and materials.
PSI’s Information Technology
Central Infrastructure
Clinical data and metadata concerning biomaterials from local sources in 8 UMC’s are uploaded at regular time intervals to a central database for storage on a national level. The central infrastructure provides access to clinical data collected in the participating institutions. This database can exclusively be accessed by authorized personnel. To reliably assess outcome data in patients no longer under UMC care, links are being established with other databases and registries available in the Netherlands, for instance on medication use and cause of death. A catalogue is under construction containing information on diverse characteristics of the PSI collections for instance on types and amounts of stored biomaterials and specific disease types. This will be an open access searchable database.
Local Infrastructure
Each UMC has its own research IT infrastructure that has to deliver the data to the central database. Some UMC’s have an IT infrastructure that is integrated with the clinical IT. Research oriented electronic data capture forms are an integral part of the Electronic Health Record (EHR) system. Whereas these UMC’s benefit from automatic datacapture, other UMC’s are dependent on manual data registration. Some UMC’s have local data warehouse’s to collect data from all local sources to a central place in the institution before upload. A Biobank Information Management System (BIMS) keeps track of all samples in the biobank. It documents the processing of the samples at the biobank and provides information on the donor, type of material and storage location of the samples. Each collected sample receives a unique sample code number, which is linked to the patient identification number through the BIMS.
Security
To respect the privacy of the donors upload from data to the central database takes place through a Trusted Third Party connection. Through this TTP pseudonimization of identifying data is established by special software (Trusted Reversible Encryption Service®, Houten, Utrecht, The Netherlands). Hence, the central database contains encrypted clinical data linked to unique sample code numbers. Data in the BIMS are encoded to respect the privacy of the donors. As to further protect the privacy of the patients the data export at delivery to the researchers passes through another pseudonymization. PSI policies are established in close cooperation with security and privacy officers in the institutions. Under strict conditions and according to a SOP depseudonimization can be carried out. This is needed for instance in case of necessary linkage of data or in the event of actionable incidental findings that have to be reported to the institutions. In that case biological samples and data have to be traced back to the original participant. …
After acquisition, scans are pseudonymized according to predefined and centralized
guidelines. Pseudonymized images are subsequently transferred to the central PSI facility.
Collaboration
PSI connects with other developments: Electronic Health Records, Detailed Clinical Models; quality audits, etc. PSI cooperates with other (inter)national biobanking networks e.g.: BBMRI-NL, LifeLines, BioSHaRE, CTMM, TraIT, P3G, etc.

Connection to strategic developments
Topsectors:
ESFRI:
Health and Food
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