FLOWER is a completely virtual, nationwide, real-world observational study to collect, annotate, standardize, and report clinical data for rare diseases. Patients participate in the study by electronic consent (eConsent) and sign a medical records release to permit data collection. Medical records are accessed from institutions directly via eFax or paper fax, online from patient electronic medical record (EMR) portals, direct from DNA/RNA sequencing and molecular profiling vendors, and via electronic health information exchanges. Patients and their treating physicians may also optionally provide medical records. Medical records are received in or converted to electronic/digitized formats (CCDA, FHIR, PDF), sorted by medical record type (clinic visit, in-patient hospital, out-patient clinic, infusion and out-patient pharmacies, etc.) and made machine-readable to support data annotation, full text searches, and natural language processing (NLP) algorithms to further facilitate feature identification.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Overall Survival (OS)
Timeframe: 5 Years
Safety/tolerability of medications
Timeframe: 5 years
Changes in normal development milestones
Timeframe: 5 years
Changes in functional status
Timeframe: 5 years
Changes in motor function
Timeframe: 5 years
Changes in symptoms or clinical status
Timeframe: 5 years