The distinction
| True | Not true |
|---|---|
| IRB approval covers the registry protocol and its consent | Any substance, dose, protocol or clinic |
| Participants are consented contributors to an observational registry | Research subjects in a trial |
| Non-interventional; no product supplied or assigned | An IND, IDE or FDA authorization |
| Treatment decisions belong to clinician and patient | Directed by the registry |
Why registries matter
Randomized trials answer narrow questions slowly and expensively. Registries answer the question patients actually ask: what happened to people like me, treated the way I am being treated, over a year. With enough sites, that becomes the evidence base a regulator can read.
Language
Registry, not study. Participant, not subject. Nothing is "IRB approved" except the data collection. We do not use participation as a selling point, and neither should any site.
Privacy
Identifiers are removed at the site. What reaches the registry is a coded record. Identifiable records never leave the enrolling clinic.
Educational. Not medical advice. Treatment decisions are made by a licensed clinician with the patient. Nothing here describes a product as approved by any regulator.