Data Governance

Data Security

Data entry privileges will be restricted to a centre’s research team members with individual password-protected access. Access to the Registry database will be restricted to authorised users with separate higher-level access. An audit trail will be maintained to identify all data entries and amendments.

Data Collection/Storage

A ’core’ and optional ‘extended’ dataset will be created with agreed data elements to be collected with harmonised definitions, common coding systems and common data entry procedures. Data will be collected from the patient’s routine medical records by the attending clinical research team and submitted online for storage in a secure GDPR-compliant (or equivalent) cloud server. Data will be pseudo-anonymised using a unique study/centre identification number; no names, initials or address details will be collected or stored centrally. Individual centres can choose to link study numbers to local databases to allow identification of patients to correct data entry errors, to avoid duplicate registration and to facilitate recruitment into future research studies.

Data items will include maternal and infant demographics, clinical diagnosis, diagnostic parameters including echocardiographic indices, therapeutic interventions and short- and long-term (6 month to 5 year) outcomes. If any Registry data items are not collected routinely as part of a centre’s normal patient care, clinical care will not be changed just to accommodate collection of additional data. However, within the full cohort there will be opportunities for further stand-alone ethically-approved research into selected sub-groups which might include identifications of biomarkers that predict disease severity, treatment-response and clinical outcome.

Quality Assurance of Data

A Database Administrator will be responsible for overseeing data integrity and liaising with participating centres to rectify ambiguous or inconsistent data entry. The risk of inaccurate and incomplete data will be minimised by strict validation rules for data entry and mandated data fields. A data extraction process will be agreed to support quality control activities.

Data Protection and Patient Confidentiality

Registry data will be subject to the regulations on data protection (national and international regulations such as HIPAA, Part-11, and FISMA standards (USA), General Data Protection Regulation 2018 (GDPR) (EU) and the UK Data Protection Act 2018). All information submitted by centres will be anonymised, treated confidentially and transmitted and stored securely. Participants’ data will be kept for an indefinite period on a secure server, under the responsibility of the Chief Investigator and the Registry Executive Committee.

Data Ownership

Individual sites will retain the ability to download summary data relating to their own centre from the Registry website. The Registry Executive Committee will have overall ownership of the data held in the Registry and will be responsible for its secure handling and storage.

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