Registry Data
The ISAR registry is a rich source of real-life data for scientific research, offering insights into the experiences of patients with severe asthma from around the world.
Ethics in ISAR
Countries collaborating with ISAR are subject to country-specific ethical regulations and hence, would be required to seek local ethics approval before sharing de-identified, anonymous patient level data with ISAR. Countries have the flexibility to apply for centralised ethical approvals or site-specific ethics approval as required in their country. The ISAR team will provide ethics support and resources to guide the local ethics applications as necessary.
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All research projects utilising ISAR data would be subject to approval by the ISAR Steering committee (ISC): as well as ethical approval by the ADEPT committee. The ISC is made up of ~48 pulmonary experts across ~26 collaborating countries who are solely responsible for overseeing the scientific merit of all research proposals, while the ADEPT committee made up of database and clinical research experts within the REG; is responsible for overseeing ethical governance of research proposals arising out of ISAR.
How data is collected?
The ISAR data collection process endeavours to maximise existing data available in electronic medical records as well as bespoke national level registries by facilitating the consolidation with incoming data from new registries where primary data collection is supported via electronic Case Report Forms (eCRFs). While ISAR supports data collection via multiple platforms such as REDCap, etc, new registries primarily use the electronic data capture system freely provided by ISAR, OpenClinica; which is specifically designed to collect real-life data. Regardless of the source, patient privacy is always maintained via mandatory anonymisation, or de-identification of individual patient data at the source or at the point of collection and only the health care providers will be able to identify their patients at their local sites.
Where is ISAR data held?
ISAR international data is hosted at Optimum Patient Care, United Kingdom.
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Optimum Patient Care is registered on the Data Protection Register reference: ZA197058 and is compliant with the EU General Data Protection Regulation (GDPR).
Who owns the data?
As per ISAR’s founding principle, all collaborating countries or their respective contracting bodies (e.g. National thoracic society, severe asthma clinic, etc) own their data and are free to share their data and conduct their own research.
OPC or AstraZeneca do not own any data held in the international repository. Collaborators are only required to share fully anonymized data for research approved by the ISAR Steering Committee and the ADEPT Committee.