Determine Who Should Join
Determine Geography
Decide whether your registry will be national or international. To start, it may be easier to recruit only participants who live in the same country as you. To meet your registry goals, you may need to expand the geographic area to include participants from many countries (especially for an ultra-rare disease).
Consider:
- How many people have the disease?
- Where do participants live (which countries)?
- How many participants do you need to meet your registry goals?
- Are you familiar with the data security and privacy laws in other countries? (e.g., The EU General Data Protection Regulation (GDPR) )
National:
- PRO: An option if there are many participants living in one country.
- CON: People from other countries may not be able to participate.
International:
- PRO: An option if there are few participants in any one country.
- CON: Multiple languages, time zones, and cultural differences will create additional challenges.
Resources
Set Language Requirements
Chapter 3: Registry Design in Registries for Evaluating Patient Outcomes: A User’s Guide, [internet]. 4th Edition
Agency for Healthcare Research Quality (AHRQ) (link)
Establish Diagnostic Criteria
HIPAA Privacy Rule: Information for Patients
U.S. Department of Health and Human Services: Health Information Privacy (link)