Self paced coursePatient Registries 101
A self paced course for advocacy groups creating and managing disease registries, with Dr. Danielle Boyce. Nineteen modules across six parts take you from defining a registry's purpose through governance, data architecture, collection, participants, partnerships, and analysis.
Planning
Define your registry's purpose, establish governance, build a scientific advisory board, and choose the right platform.
Fit for Purpose, Defining Your Registry's Goals
Define your registry's primary purpose before a single line of data is collected. This decision shapes every subsequent choice about data elements, platform, governance, and partnerships.
Governance & IRB
Establish the governance structures and regulatory approvals your registry needs before collecting any data.
Scientific Advisory Boards
Build a Scientific Advisory Board (SAB) that provides genuine scientific direction, not just credibility optics, and structure it to serve your registry's long term needs.
Choosing a Platform or Vendor
Evaluate and select the technology platform that best fits your registry's purpose, budget, and long term data needs.
Data Architecture
Common data elements, standardized vocabularies, HPO/GA4GH/Phenopackets, and OMOP, the standards that make data reusable.
Common Data Elements
Understand what Common Data Elements (CDEs) are, why they matter, and how to select and implement them to make your registry data maximally reusable.
Standardized Vocabularies
Learn the key medical terminologies and coding systems your registry should use to ensure data is interoperable, searchable, and ready for research.
HPO, GA4GH & Phenopackets
Understand the Human Phenotype Ontology (HPO), the GA4GH data sharing framework, and Phenopackets, the emerging standard for exchanging participant phenotype and genomic data.
OMOP & the OHDSI Network
Understand the OMOP Common Data Model and the OHDSI network, and evaluate whether converting your registry to OMOP is right for your goals.
Data Collection
EHR integration via C-CDA and FHIR, patient-reported data under the 21st Century Cures Act, questionnaire design, and data verification.
EHR Integration, CCDA & FHIR
Understand how to extract structured clinical data from EHR systems using industry standards, reducing participant burden and improving data quality.
Patient-Reported Data & the 21st Century Cures Act
Understand how the 21st Century Cures Act creates participant rights to access their EHR data via APIs, and how your registry can leverage this.
Designing Questionnaires
Design questionnaires that produce high-quality, analyzable data, and that participants actually complete.
Verifying Clinical Data
Understand when and how to verify patient-reported data against clinical records, and build a data quality framework for your registry.
Participants
Recruitment strategies that work for rare diseases, and how to work effectively with study coordinators at clinical sites.
Recruitment Strategies
Build a recruitment strategy that reaches your community effectively, with particular attention to the unique challenges of rare disease recruitment.
Working with Study Coordinators
Understand the role of study coordinators in multisite registries and how to build effective relationships with clinical sites.
Partnerships
Working productively with industry sponsors and academic collaborators, protecting participant interests while advancing science.
Working with Industry Sponsors
Build productive partnerships with pharmaceutical and biotech companies while protecting participant interests, data integrity, and your organization's independence.
Working with Academia
Build productive research collaborations with academic institutions that advance science, produce publications, and respect advocacy organization interests.
Using Your Data
Analysis approaches, data sharing frameworks, and turning your registry into peer reviewed publications.
Analyzing Registry Data
Understand the analytic approaches used in registry research and how to design your registry for analysis from the start.
Data Sharing
Develop a data sharing framework that maximizes the scientific value of your registry while protecting participant privacy and your organization's interests.
Publications
Turn your registry data into peer reviewed publications that establish your organization as a scientific leader and advance the field.
Take it with youDownload the course
Read offline, print, or present. Each module page also has its own slides.