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| Introduction |
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Unit 1 Welcome/Historical Perspective/Choosing a Research Question John I. Gallin, M.D. Running Time: 75 minutes Download Materials - Choosing a Research Question Download Materials - Evaluation of Alternative and Complementary Therapies |
| Module I - Epidemiologic Methods |
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Unit 1 Issues in Randomization Laura Lee Johnson, Ph.D. Running Time: 69 minutes |
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Unit 2 Design of Epidemiologic Studies Jack Guralnik, M.D., Ph.D. Running Time: 85 minutes |
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Unit 3 Study Development Jack Guralnik, M.D., Ph.D. Running Time: 82 minutes |
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Unit 4 Economic Analysis in Clinical Research Martin Brown, Ph.D. Running Time: 83 minutes |
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Unit 5 Measures Audrey Thurm, Ph.D. Running Time: 48 minutes |
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Unit 6 Overview of Hypothesis Testing Laura Lee Johnson, Ph.D. Running Time: 76 minutes |
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Unit 7 Participant Selection and Using Secondary Data and Meta Analysis Tamara Harris Running Time: 76 minutes Download Materials - Participant Selection and Using Secondary Data and Meta Analysis |
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Unit 8 Special Lecture: Unanticipated Risk in Clinical Research Stephan Straus, M.D. Running Time: 67 minutes |
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Unit 9 Sample Size and Power Laura Lee Johnson, Ph.D. Running Time: 78 minutes Download Materials - Sample Size and Power (prints color) Download Materials - Sample Size and Power (prints b/w) Download Materials - Randomized Phase II Clinical Trials Download Materials - Early Selection in a Randomized Phase II Clinical Trial Download Materials - A Two-Stage Design for Choosing Among Several Experimental Treatments... Download Materials - Namograms for Calculating the Number of Patients Needed.... Download Materials - Optimal Two-Stage Design for Phase II Clinical Trials |
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Unit 10 Conceptual Approach to Survival Analysis Laura Lee Johnson, Ph.D. Running Time: 86 minutes Download Materials - Conceptual Approach to Survival Analysis (Prints Color) Download Materials - Conceptual Approach to Survival Analysis (Prints B/W) |
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Unit 11 Opportunities for Innovation in Clinical Research: From Molecule to Medicare Mitchell Max , M.D. Running Time: 91 minutes Download Materials - core1.ppt Download Materials - core2.ppt Download Materials - core3.ppt |
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Unit 12 Designing and Testing Questionnaires Jack Guralnik, M.D., Ph.D. Running Time: 53 minutes |
| Module II - Ethical Issues in Human Subjects Research |
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Unit 1 Ethical Principles in Clinical Research Christine Grady, Ph.D. and Researching an Ethics Question Ezekiel Emanuel, M.D., Ph.D. Running Time: 95 minutes Download Materials - Ethical Principles in Clinical Research |
| Module III - Monitoring Patient Oriented Research and Regulatory Issues |
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Unit 1 Special Lecture: Human Genome Project and Clinical Research Christopher Austin, M.D. and Quality Control in Clinical Trials Jack Guralnik, M.D., Ph.D. Running Time: 85 minutes |
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Unit 2 Data Management in Clinical Trials Anne Tompkins, R.N., M.S.N. Running Time: 52 minutes |
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Unit 3 Data and Safety Monitoring Boards Frederick Ferris, M.D. Running Time: 60 minutes |
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Unit 4 Product Development: Moving from the Bench to the Clinic Phillip Gomez, Ph.D., M.B.A. and The Clinical Researcher and the Media John Burklow, M.S. Running Time: 81 minutes |
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Unit 5 Clinical Research from the Patient's Perspective Susan Butler, B.A., M.A. Running Time: 63 minutes Download Materials - Clinical Research from the Patient's Perspective |
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Unit 6 Quality of Life John Ware, Ph.D. Running Time: |
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Unit 7 FDA Product Regulation Kathy Zoon, Ph.D. Running Time: 53 minutes |
| Module IV - Preparing and Funding a Clinical Research Study |
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Unit 1 NIH Peer Review Process Olivia Preble-Bartlett, Ph.D. Running Time: |
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Unit 2 ProtoType and Protocol Mechanics Robert Nussenblatt, M.D Running Time: 62 minutes |
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Unit 3 Concepts in the Management of Projects Charles Grudzinskas, Ph.D. and Design of Case Report Forms David Mailhot, B.S., M.P.H. Running Time: 80 minutes |
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Unit 4 Evaluation of a Protocol Budget Margaret Matula, B.S.N., M.G.A. Running Time: 69 minutes |
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Unit 5 Technology Transfer - Part I Jack Spiegel, M.D. and Technology Transfer - Part II Bruce Goldstein, J.D., M.S. Running Time: 97 minutes |
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Unit 6 Evaluation of Alternative and Complementary Therapies Marc Blackman, M.D. and Inclusion of Women and Minorities in Clinical Trials Miram Kelty, Ph.D. Running Time: 93 minutes Download Materials - Evaluation of Complementary and Alternative Therapies Download Materials - Inclusion of Women and Minorities in Clinical Trials |
Warren Grant Magnuson Clinical Center National Institutes of Health Bethesda, Maryland 20892-7511 |