Forms and documents · PPRN-001-2025
Everything a site or network needs, in one place.
Download, print, sign, file. The participant consent and the investigator agreement are the only two pieces of paper a clinic ever touches. Networks onboarding many clinics use the two CSV templates and the onboarding guide.
- Participant informed consentThe IRB-approved consent each participant signs at the clinic before any data is recorded. Print it, sign it in the office, keep it in the chart. It never leaves the clinic.PDF · 5 pages
- Investigator agreementSigned once by the treating clinician at each site. Return to the registry or hand it to your network coordinator. The online application at /apply/ is the e-signed equivalent.PDF · 1 page
- Site participant consent v2.0What every participating site agrees to: reporting windows, de-identification, record retention. Versioned and fingerprinted; the application form signs this text.Web · printable
- Protocol PPRN-001-2025The approved protocol: aims, population, data elements, follow-up schedule, safety reporting. Read it before enrolling anyone.PDF · 18 pages
- IRB approval letterInstitute of Regenerative and Cellular Medicine IRB, approval IRCM-2025-467, continuing review Dec. 2, 2026. Show this to anyone who asks under whose oversight the registry runs.PDF · 1 page
- Site roster templateFor networks and groups onboarding several clinics at once: one row per clinic. Send it to the registry and site codes come back the same day.CSV
- Batch submission templateThe column set for bulk visit submission by a network coordinator: one row per visit per molecule, de-identified, keyed by site code and registry subject ID. Matches the fields on the Submit data page.CSV
- Registry FAQ: what data we needThe four things we need per visit, what is optional, what is never sent, deadlines, ownership, what you can say publicly.PDF
- Network onboarding guideHow a multi-clinic network joins and submits in bulk: roster, one signature per clinician, data capture at the appointment, batch submission, reporting windows.PDF
Rules of the road
Identifiers stay at the clinic. Say "under an active IRB protocol (PPRN-001-2025)", never "IRB approved" on any product or advertisement. Registry participation is never a condition of any purchase. Questions: contact@mortensenmedical.com.