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http://dx.doi.org/10.1201/9781420025941
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Front MatterAbstract - Hi-Res PDF (269 KB) - PDF w/links (158 KB)
Chapter 1. Overview of Clinical ResearchAbstract - Hi-Res PDF (523 KB) - PDF w/links (189 KB)
Chapter 2. Fda Regulations and Good Clinical Practice GuidelinesAbstract - Hi-Res PDF (1072 KB) - PDF w/links (352 KB)
Chapter 3. The StudyAbstract - Hi-Res PDF (500 KB) - PDF w/links (189 KB)
Chapter 4. Interactions with the SponsorAbstract - Hi-Res PDF (464 KB) - PDF w/links (183 KB)
Chapter 5. Interactions within the InstitutionAbstract - Hi-Res PDF (161 KB) - PDF w/links (87 KB)
Chapter 6. The Role of the Study SubjectAbstract - Hi-Res PDF (702 KB) - PDF w/links (248 KB)
Chapter 7. Data ManagementAbstract - Hi-Res PDF (272 KB) - PDF w/links (119 KB)
Chapter 8. Adverse EventsAbstract - Hi-Res PDF (616 KB) - PDF w/links (209 KB)
Chapter 9. Investigational Agent ManagementAbstract - Hi-Res PDF (446 KB) - PDF w/links (185 KB)
Chapter 10. Inspection of Clinical Research SitesAbstract - Hi-Res PDF (325 KB) - PDF w/links (133 KB)
Appendix A. Fda RegulationsAbstract - Hi-Res PDF (4359 KB) - PDF w/links (1672 KB)
Appendix 1. AbbreviationsAbstract - Hi-Res PDF (79 KB) - PDF w/links (56 KB)
Glossary of TermsAbstract - Hi-Res PDF (563 KB) - PDF w/links (205 KB)