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| Introduction |
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Unit 1 Welcome/Historical Perspective/Choosing a Research Question Running Time: 66 minutes John I. Gallin, M.D. Download Materials - Welcome/Historical Perspective/Choosing a Research Question |
| Module I - Epidemiologic Methods |
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Unit 1 Participant Selection Running Time: 80 minutes Tamara Harris, M.D., M.S. and Using Secondary Data and Meta Analysis Running Time: Tamara Harris, M.D., M.S. Download Materials - Participant Selection Using Secondary Data and Meta Analysis |
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Unit 2 Design of Epidemiologic Studies Running Time: 81minutes Laura Lee Johnson, Ph.D. |
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Unit 3 Study Development Running Time: 81 minutes Laura Lee Johnson, Ph.D. |
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Unit 4 Issues in Randomization Running Time: 85 minutes Laura Lee Johnson, Ph.D. Download Materials - Issues in Randomization Download Materials - Observational Trials Reporting Standards Download Materials - Clinical Trials Design Issues |
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Unit 5 Measures Running Time: 59 minutes David Black, Ph.D. |
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Unit 6 Economic Analysis in Clinical Research Running Time: 58 minutes Martin Brown, Ph.D. |
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Unit 7 Overview of Hypothesis Testing Running Time: 91 minutes Laura Lee Johnson, Ph.D. Download Materials - Overview of Hypothesis Testing Download Materials - Overview of Hypothesis Testing (B/W Version) |
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Unit 8 Sample Size and Power Running Time: 89 minutes Laura Lee Johnson, Ph.D. Download Materials - Optimal Two-Stage Designs for Phase II Clinical Trials Download Materials - Steinberg Venzon Download Materials - Simon Wittes Ellenberg 1985 Download Materials - Thall Two-Stage Download Materials - Subgroup and Interim Analysis Review Download Materials - Survival Sample Size Download Materials - Wittes Sample Size Primer |
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Unit 9 Opportunities for Innovation in Clinical Research: From Molecule to Medicare - Part I Running Time: 45 minutes Mitchell Max , M.D. and Opportunities for Innovation in Clinical Research: From Molecule to Medicare - Part II Running Time: 47 minutes Joanne Lynn, M.D. Download Materials - Opportunities for Innovation in Clinical Research - Part I Download Materials - Opportunities for Innovation in Clinical Research - Part II |
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Unit 10 Conceptual Approach to Survival Analysis Running Time: 90 minutes Laura Lee Johnson, Ph.D. Download Materials - Conceptual Approach to Survival Analysis Download Materials - Conceptual Approach to Survival Analysis (B/W Version) |
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Unit 11 Designing and Testing Questionnaires Running Time: 55 minutes Jack Guralnik, M.D., Ph.D. |
| Module II - Ethical Issues and Regulation of Human Subjects Research |
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Unit 1 Researching an Ethics Question Running Time: 49 minutes Ezekiel Emanuel, M.D., Ph.D. and Ethical Principles in Clinical Research Running Time: 40 minutes Christine Grady, Ph.D. Download Materials - Researching an Ethics Question Download Materials - Ethical Principles in Clinical Research |
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Unit 2 Running Time: 44 minutes and Scientific Conduct Running Time: Joan Schwartz, Ph.D. |
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Unit 4 Quality Control in Clinical Trials Running Time: 50 minutes Jack Guralnik, M.D., Ph.D. |
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Unit 5 Special Lecture: Human Genome Project and Clinical Research Running Time: 60 minutes Christopher Austin, M.D. Download Materials - Human Genome Project and Clinical Research |
| Module III - Monitoring Patient-Oriented Research and Regulatory Issues |
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Unit 1 FDA Product Regulation Running Time: 52 minutes Robert Yetter, Ph.D. |
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Unit 2 The Clinical Researcher and the Media Running Time: 41 minutes John Burklow, M.S. and Product Development: Moving from the Bench to the Clinic Running Time: 46 minutes Kimberlee Wallace, Ph.D. |
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Unit 3 Data and Safety Monitoring Boards Running Time: 56 minutes Dennis O. Dixon, Ph.D. |
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Unit 4 Data Management in Clinical Trials Running Time: 42 minutes Anne Tompkins, R.N., M.S.N. and Legal Issues in Clinical Research Running Time: 48 minutes Valerie Bonham, J.D. |
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Unit 6 Clinical Research from the Patient's Perspective Running Time: 63 minutes Susan Butler, B.A., M.A. Download Materials - Clinical Research from the Patient's Perspective |
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Unit 7 Quality of Life Running Time: 68 minutes John Ware, Ph.D. |
| Module IV - Preparing and Funding a Clinical Research Study |
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Unit 1 Evaluation of a Protocol Budget Running Time: 60 minutes Margaret Matula, B.S.N., M.G.A. Download Materials - Evaluation of a Protocol Budget Download Materials - Evaluation of a Protocol Budget (Print Version) |
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Unit 2 NIH Peer Review Process Running Time: 73 minutes Olivia Preble-Bartlett, Ph.D. Download Materials - NIH Peer Review Process Download Materials - NIH Peer Review Process (Print Version) |
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Unit 3 Information Resources for Clinical Research Running Time: 36 minutes Josh Duberman, M.L.I.S. and Concepts in the Management of Projects Running Time: Charles Grudzinskas, Ph.D. Download Materials - Concepts in the Magnagement of Projects (Print Version) Download Materials - Information Resources for Clinical Research Download Materials - Information Resources for Clinical Research (Print Version) |
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Unit 4 Design of Case Report Forms Running Time: 52 minutes David Mailhot, B.S., M.P.H. Download Materials - Design of Case Report Forms Download Materials - Design of Case Report Forms (Print Version) |
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Unit 5 ProtoType and Protocol Mechanics Running Time: 27 minutes Philip Lightfoot, B.S., B.A. |
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Unit 6 Technology Transfer - Part I Running Time: 51 minutes Jack Spiegel, M.D. and Technology Transfer - Part II Running Time: 61 minutes Bruce Goldstein, J.D., M.S. Download Materials - Technology Transfer - Part I Download Materials - Technology Transfer - Part I (Print) |
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Unit 7 Inclusion of Women and Minorities in Clinical Trials Running Time: 43 minutes Miriam Kelty, Ph.D. and Evaluation of Alternative and Complementary Therapies Running Time: 56 minutes Marc Blackman, M.D. Download Materials - Inclusion of Women and Minorities Download Materials - Inclusion of Women and Minorities (Print Version) Download Materials - Alternative and Complementary Medicine Download Materials - Alternative and Complementary Medicine (Print Version) |
Warren Grant Magnuson Clinical Center National Institutes of Health Bethesda, Maryland 20892-7511 |