WHI Study Manuals
Select the desired study phase below to review relevant manual sections and appendices.
Clinical Trials & Observational Study (1993-2005)
- Table of Contents and Introduction
- Section 1: Protocol For Clinical Trial And Observational Study Components
- Protocol Appendix 1: Baseline and Follow-up Variables
- Protocol Appendix 2: Overview of Classification Procedures and Definitions of Clinical Outcomes
- Protocol Appendix 3: Statistical Power for Women"s Health Initiative Clinical Trial and Observational Study
- Protocol Appendix 4: Consent Forms -- listing moved to Volume 1, Section 2, below. See also protocols and study consents.
- Protocol Appendix 5: Women"s Health Initiative Observational Study Overview of Objectives and Hypotheses
- Protocol Appendix 6: Dietary Intervention Program and Dietary Assessment Methods
- Protocol Appendix 7: Study Units and Principal Investigators -- this appendix has been replaced by the WHI Directory
- Protocol Appendix 8: Brief Protocol History
- Protocol Appendix 9: Bibliography
- Section 2: Consent Forms Table of Contents
- Section 3: Study Policies
- Table of Contents
- Section 1: Introduction to WHI Clinical Trials and Observational Study
- Section 2: Clinical Center Guidelines
- Section 3: Recruitment
- Section 4: Screening
- Section 5: Hormone Replacement Trial (HT)
- Section 6: Dietary Modification (DM)
- Section 7: Calcium and Vitamin D Intervention (CaD)
- Section 8: Observational Study (OS)
- Section 9: Clinical Measurements
- Section 10: Dietary Assessment
- Section 11: Blood and Urine Collection, Processing, and Shipment
- Section 12: Mammography
- Section 13: ECG Procedures (Figure 13.11 provided separately)
- Section 15: Medications (Study Pills)
- Section 16: Follow-up Contacts (Figure 16.7 provided separately)
- Section 17: Retention
- Section 17: Retention
- Section 18: Data Management
- Section 18: Data Management
- Section 20: Special Populations Considerations
- Appendices
- Table of Contents and Introduction
Please visit the WHI Questionnaires page to view individual study forms.
Note: Some materials include versions for participants (PPT) and nutritionists (NTR).
Year 1: Intervention
Years 2-10: Maintenance
Year 2 - 1995
Year 3 - 1996
Year 4/5 - 1998
Year 5/6 - 1999
*Note: Two transitition sessions were repeated during the procedural change from session sequence to calendar sequence. During Spring 1998 and Summer 1998, alternatives were provided for groups that had already received these sessions during 1997.
Year 7/8 - 2001
Year 8/9 - 2002
- Table of Contents
- Section 1: Introduction to WHI Outcomes
- Section 2: Outcomes Ascertainment (Table 2.1 provided separately)
- Section 3: Physician Adjudication
- Section 4: Outcomes Classifications - Cancer Outcomes
- Section 5: Outcomes Classifications - Cardiovascular Outcomes
- Section 6: Outcomes Classifications - Fracture Outcomes
- Section 7: Fatal Events
- Appendices
- Appendix A: Outcomes Forms and Instructions
Please visit the WHI Questionnaires page to view individual outcomes reporting forms.
- Appendix B: Letters and Forms
- Appendix C: Coding Reference
- Appendix D: Explanation of Terms
- Appendix E: Medications Used for the Treatment of Cardiovascular Disease
- Appendix F: Sample Outcomes Documents
- Appendix G: Sample Medical Chart
- Appendix H: Summary of Bulletins in Volume 8
- Appendix I: Outcomes Reports
Extension Study 2 (2010-2020)
- Table of Contents
- Section 1: Extension Study Protocol
- Section 2: Consent
- Section 4: Regional Center Communication, Documentation, and Guidelines
- Section 5: Guidelines for Interactions with Participants
- Section 6: Enrollment
- Section 7: Follow-Up Contacts
- Section 8: Outcomes
- Section 9: Retention
- Section 11: Quality Assurance
