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Documents Received by the Institute of Medicine from the National Institutes of Health
Received: March 1993
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Solicitation (RFP) NIH-WH-92-13
Clinical Coordinating Center for the Clinical Trials and Observational
Dated: 3/1/72
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Amendments to Solicitation NIH-WH-92-13
Clinical Coordinating Center for the Clinical Trials and Observational Study of the Women's Health Initiative
Dated: 4/22/92
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Solicitation (RFP) NIH-WH-92-19-E
Vanguard Clinical Centers for Clinical Trials and Observational Study of the Women's Health Initiative
Dated 4/29/92
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Amendments to Solicitation NIH-WH-92-19-E
Vanguard Clinical Centers for Clinical Trials and Observational Study of the Women's Health Initiative
Dated 4/29/92
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Information to Offerors
Subheadings
Scientific Information
Objectives
Inclusion Criteria for Clinical Trial
Exclusion Criteria for Clinical Trial
Enrollment
Key Baseline and Follow-Up Variables
Clinical Outcomes of Interest
Partial Factorial Design
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Testimony from NIH Women's Health Initiative Public Hearing, October 28-29, 1991.
Received: May 25, 1993
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May 13, 1993 Protocol (was not yet approved)
Received: May 31, 1993
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March 8, 1993 Protocol (approved)
Received: July 7, 1993
Response to June 29, 1993 Dr. Thaul letter
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RFP: NIH-WH-93-30
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Business Proposals from the Vanguard Centers, with all cost information deleted
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June 28, 1993 Protocol (approved by the Data Safety and Monitoring Board, June 16, 1993) red-lined
Received: July 9, 1993
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Behavioral constructs
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Description and cost information of NIH-sponsored women's health studies
Received: July 12, 1993
Additional response to June 29, 1993 Dr. Thaul letter
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RFP: July 7, 1993
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Power calculations and sample size information from Laurence Freedman
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Additional quality of life construct information from Robert Kaplan
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Journal articles on clinical trials
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Incidence tables on colorectal cancer, hip fractures, and other fractures
Received: July 26, 1993
Additional response to June 29, 1993 Dr. Thaul letter
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VCC levels of effort and budget information (does not include salaries)
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Description and cost information of NHLBI-sponsored women's health studies
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Information and costs re Women's Health Studies in NIH institutes
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Proceedings from the October 28, 1991 Public Hearing
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Letter from Reubin Andres on the Baltimore Longitudinal Study
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Report on Progress: Study Design and Time Line. Memo, October 17, 1991.
Received: August 3, 1993
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Information on the Women's Health Trial Feasibility Study in Minority Populations
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May 13, 1991 Technical and Scientific Working Group, including:
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Draft Proposal from NHLBI; Osteoporosis Component;
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Draft Proposal from NCI and NHLBI;
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Recommendations for Design of Trials;
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NCI Biometry Branch; Recommendations for Cancer
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Biomarker and Prevention Studies, NCI; and
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NCI Biometry Branch; Recommendations for Cancer
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Biomarker and Prevention Studies, NCI; and
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Repository Feasibility Information, NCI
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NIDDK Proposal for Obesity Component (May 13, 1991)
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Proposal by Scientific and Technical Working Group on WHI (June 4, 1991)
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Consultant Recommendations on Endometrial Biopsies (June 27, 1991)
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Reviews by Susan R. Johnson (On behalf of group of PEPI gynecology consultants) (July 23, 1991 and August 5, 1991)
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Minutes of Advisory Meeting on Calcium/Vitamin D Intervention (August 15, 1991)
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Minutes of Meeting with Expert Consultants in Epidemiology (September 13, 1991)
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Review by ICD Directors October 17, 1991
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Protocol Comments from Jeffrey A. Perlman, Chief, Contraceptive and Reproductive Evaluation Branch (October 22, 1991)
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Comments on WHI Prospectus by Linda J. Golden, FDA, Center for Drug Evaluation and Research (November 20, 1991)
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Minutes of Concept Review for Clinical Trial and Observational Study of the WHI (January 15, 1992)
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Minutes of Hormone Replacement Working Group Meeting (January 21, 1993)
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Minutes of Advisory Meeting for Dietary Intervention (May 10, 1993)
Received: August 4, 1993
Response to July 27, 1993 Dr. Thaul letter
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Memo from Jacques Rossouw, with attachments:
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age distribution;
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rate calculations;
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power calculations;
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discussion of dietary modification and breast cancer hypothesis;
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Hollinghead scale;
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adjustments to minority group rate;
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budgets for additional 6,000 WHI CT participants;
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subcommittee membership rosters;
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Data Safety and Monitoring Board documents;
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memo from Mark Kestin on plasma triglycerides and a low fat diet;
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information on why calcium and vitamin D are combined in the Clinical Trial;
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minutes from the Concept Review meeting for the Clinical Trial and Observational Study; and
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the scripts for the VCC videotapes.
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Additional response to June 29, 1993 Dr. Thaul letter
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Description and cost information of NIH-sponsored women's health studies, including:
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NHLBI; NIDDK; NCI; NINDS; NCI; NIAMS; NIDR; NIAAA; NIA; and
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other multi-ICD-sponsored studies
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