The Learning Health and Social Services Research Platform
Developped for the Quebec SUPPORT UNIT (Data access sub-group) of the Strategy for Patient-Oriented Research (SPOR).
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PARS3 Project Summary
The Learning Health and Social Services Research Platform (PARS3) is an ecosystem that will encourage and facilitate the collaboration of users (e.g. researchers, clinicians, patients) with clinical data access officers (e.g. clinics, research registries). Being part of a learning health system, these activities are linked together to foster a rapid return to clinical care in order to improve patient outcomes.
To achieve this, PARS3 that will support the development and execution of projects in three main areas: observational studies, clinical trials, and knowledge transfer (including audits and feedback, decision support systems and reflexive practice). To do so, it relies on an ontological model enabling the presentation of a clinically sound and understandable concepts to the users while supporting exact and coherent extractions across diverse technical systems.
PARS3 will enable all project participants to have a clear view of what they are engaging in. The formal project design and digital signatures process includes the possibility to formalize the pertinent ethical rules, norms and laws to be followed regarding data extraction for each project. PARS3 can then ensure the respect of these rules throughout the execution of the project. Security by design principles are integrated across the system. Transmitting personally identifying information or not is a choice for each project and the platform can support both. Finally, extracted data transmitted to the users is structured according the CDISC ODM standard which is now required for submission by regulating bodies like the FDA.
It is important to note that PARS3 does not contain a data warehouse. Only the minimum information required to answer a specific query from a specific project is extracted from each site (only for the eligible patients and only for the required data elements), encrypted and directly delivered to a designated secured location. For any data to leave a site, a formal project document must have been digitally signed by the data access officer of the clinic.
Time being precious and scarce in multiple institutions, PARS3 supports the participation of clinical advisors (e.g. the person in charge of research in Practice-Based Research Network) and ethical advisors to first analyze the project requests. The data access officer in each clinic (e.g.: the person in charge of the clinic) could then receive only highly relevant requests for final approval.