Table of Contents
Guidance for Industry Establishing Pregnancy Registries
Outline
Why a Pregnancy Registry Guidance Document?
What is a Pregnancy Registry?
What is the Purpose of a Pregnancy Registry?
Limitations of Current Data Sources
What is the Purpose of a Pregnancy Registry Protocol?
What are Pregnancy Registries?
What are Pregnancy Registries? (continued)
Pregnancy Registry Studies
Considerations for Design of a Pregnancy Registry
What Products are Good Candidates?
What Products are Good Candidates? (continued)
When in a Medical Product’s Lifetime should a Registry be Established?
What are the Elements to Consider in the Pregnancy Registry Design?
Registry Design: Protocol
Registry Design: Research Methods
Research Design: Recruitment
Research Design: Recruitment (continued)
Research Design: Recruitment (continued)
Research Design: Recruitment (continued)
Research Design: Reporting Source
Research Design: Reporting Source-Subjects
Research Design: Reporting Source - Health Care Providers
Research Design - Patient Follow-up
Research Design: Study Outcomes
Research Design: Miscellaneous
Research Design: Comparators
Research Design: Statistical Considerations
Research Design: Data Analysis
Regulatory Reporting
Additional Information
PPT Slide
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