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Pawlik, Julie A. Sosa 205 $a1st ed. 2014. 210 1$aLondon :$cSpringer London :$cImprint: Springer,$d2014. 215 $a1 online resource (197 p.) 225 1 $aSuccess in Academic Surgery,$x2194-7481 300 $aDescription based upon print version of record. 311 08$a1-4471-4678-6 311 08$a1-306-16205-X 320 $aIncludes bibliographical references and index. 327 $a1. Building your Clinical Trial Research Team -- 2. Clinical Trials: Ensuring Quality and Standardization -- 3. Statistics - Setting the Stage -- 4. Clinical Trials: Handling the Data -- 5. Data Safety Monitoring Boards -- 6. Planning for Data Monitoring and Audits -- 7. The Budget -- 8. Regulatory Considerations in Human Subjects Research -- 9. Publishing a Clinical Trial -- 10. Device Versus Drug Clinical Trials: Similarities and Important Differences -- 11. Defining the Study Cohort: Inclusion and Exclusion Criteria -- 12. History of Clinical Trials -- 13. Ethics of Clinical Trials -- 14. 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