PROMs registry software that collects, chases and exports patient-reported outcomes

A clinical trial answers a question about an intervention within a bounded period. A PROMs registry is a standing data collection. It enrolls everyone eligible at participating clinics, collects patient-reported outcome measures before and after care, and builds a dataset that clinicians, researchers or quality teams can use to compare outcomes over time or across sites. There is usually no randomization, little or no investigational product, and a protocol that is mostly about who is eligible, which instruments are used and when.

The practical consequence is that the hardest part is not the form, it is the follow-up. Registries commonly find that the baseline questionnaire is completed by almost everyone because the patient is in the clinic, while response falls at later points, when the only contact is a reminder. Non-response is rarely random: people who feel worse, or sometimes better, can be less likely to reply, which makes missing data a bias risk and not just a nuisance. A registry platform therefore has to make follow-up visible (who is due, who is late, who has not responded after how many reminders) and make responding as easy as possible.

This page is the PROMs-specific view. For the broader registry design, including observational data models, see EDC for registry studies, and for real-world study designs, EDC for real-world evidence studies. For what Capture does and does not claim here: it provides data capture, ePRO tasks, reminders, role-based access and exports. It does not connect to electronic health records or other registries, and it does not perform risk adjustment or national submissions; those happen in your own analysis and governance.

A registry holds identifiable data for years, so governance is part of the build. Role-based access separates researcher, site coordinator and admin roles; site coordinators see participant names where needed, while researchers see coded IDs, with row-level security at the database layer. Data is hosted in the EU (Frankfurt) or the USA (N. Virginia). Every change carries a field-level audit trail, and clinical data is soft-deleted only. Capture provides GDPR-ready and HIPAA-ready infrastructure, with encryption at rest and in transit; your own data protection assessment is still yours to complete, and the GDPR DPIA template is a starting point.

Consent matters most when a registry will be used for more than one purpose. Record what each participant agreed to, and keep optional elements (for example, contact for future research) as separate answers. Consent signatures are verified with an email one-time code, and the signed document exports as a PDF with the signature data, timestamps and audit trail.

For analysis, exports come as wide CSV or Excel with an automatic data dictionary, raw and decoded versions and by-site or date filtering. The export to R, SAS and SPSS page shows the workflow. If the registry is also a quality-improvement exercise, clinical audit and quality improvement data collection is the relevant companion page. Your statisticians decide on risk adjustment, case-mix and benchmarking outside Capture.