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Learn Overview Patient Registries 101 Data Analysts Grant Writers Data Sharing in a Box

Reference card

Keep this page open when planning, building, or evaluating your patient registry.

Quick decision guide: What type of registry are you building?

Purpose Key data Key consideration
Natural history Symptoms, progression, outcomes FDA acceptance; use CDEs
Trial recruitment Eligibility criteria, genotype, location Consent must distinguish from trial
Contact registry Name, email, diagnosis, interests Privacy policy; HIPAA assessment
EHR-linked Clinical records, labs, meds FHIR APIs; site agreements; Cures Act
Biosample Sample type, phenotype, consent scope ISBER standards; biosample consent
Quality of care Treatments, adverse events, hospitalization MedDRA; long term follow up

The governance checklist

  • [ ] IRB approved (commercial or institutional)
  • [ ] Consent model selected (traditional / broad / dynamic)
  • [ ] Data governance policy drafted
  • [ ] Data Access Committee formed (include participant representative)
  • [ ] Data Use Agreement template drafted
  • [ ] Publication policy defined
  • [ ] HIPAA applicability assessed
  • [ ] SAB constituted with biostatistician and participant/caregiver representation

The data architecture checklist

  • [ ] CDEs identified from NIH CDE Repository
  • [ ] PROMIS instruments selected for PROs
  • [ ] HPO terms mapped to all phenotypic features
  • [ ] Standard codes used: ICD-10, SNOMED CT, LOINC, RxNorm, ORDO
  • [ ] FHIR R4 support confirmed in platform
  • [ ] OMOP conversion plan evaluated
  • [ ] Phenopacket export capability assessed
  • [ ] Data element set reviewed by SAB

Essential standards at a glance

Standard Use Link
HPO Phenotype terms hpo.jax.org
SNOMED CT Clinical concepts browser.ihtsdotools.org
LOINC Lab tests, measurements loinc.org
RxNorm Medications mor.nlm.nih.gov/RxNav
ICD-10-CM Diagnoses (billing) icd10data.com
ORDO Rare disease classification orpha.net
MedDRA Adverse events meddra.org
FHIR R4 Data exchange hl7.org/fhir
OMOP CDM Common data model ohdsi.github.io/CommonDataModel
Phenopackets Phenotype + genomic exchange phenopackets-schema.readthedocs.io
GA4GH Data sharing framework ga4gh.org

Questions to ask your platform vendor

  1. Who owns the data? (Must be: your organization)
  2. In what format can data be fully exported?
  3. Do you sign a HIPAA BAA?
  4. What is your SOC 2 Type II status?
  5. Do you support FHIR R4?
  6. Can participants import records via SMART on FHIR?
  7. What are the costs as we scale?
  8. What is the process if we need to switch platforms?

Questions to ask an industry partner

  1. What specific data elements and analyses does your program need?
  2. Who will have access to registry data within your organization?
  3. Will you sign a data use agreement with the protections we require?
  4. How will the partnership be disclosed in FDA submissions and publications?
  5. What is your policy if registry findings are unfavorable to your program?

Questions to ask an academic collaborator

  1. Which institution's IRB will cover this analysis?
  2. What is your timeline for completing the analysis and submitting?
  3. What is your authorship expectation?
  4. Are you committed to open-access publication?
  5. Will participant coauthors and acknowledgment be included?

This reference card summarizes the Patient Registries 101 course with Dr. Danielle Boyce.

Something look wrong or unclear? Suggest a correction or send a note. EpilepsyLive is a demonstration project by Danielle Boyce, boycedatascience.com.