Guidance for Industry Establishing Pregnancy Registries

5/12/00


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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 Productís 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

Author: CDER User