Guideline Source Date Reference Nuremberg Code Nuremberg Military Tribunal United States v. Brandt et al. 1947 http://www.hhs.gov/ohrp/archive/nurcode.html Declaration of Helsinki World Medical Association 1964 http://www.wma.net/en/30publications/10policies/b3/index.html Belmont Report National Commission for…
Fig. 11.1 CONSORT statement 2010 flow diagram 11.6 Modifying Selection Criteria Under certain circumstances, it may be necessary to modify the original study eligibility criteria after recruitment has been initiated….
Timothy M. Pawlik and Julie A. Sosa (eds.)Success in Academic SurgerySuccess in Academic Surgery: Clinical Trials201410.1007/978-1-4471-4679-7_10 © Springer-Verlag London 2014 10. Device Versus Drug Clinical Trials: Similarities and Important Differences T. Clark Gamblin1 and William S. Ragalie1 (1) Department…
1. High risk or vulnerable populations 2. Trials investigating new interventions with few or no safety data available 3. Trials with primary endpoints such as mortality or major morbidity 4….
Died Survived Drug A 27 498 525 Placebo 75 500 575 102 998 1,100 The row totals are the total number of patients receiving Drug A and placebo, whereas…
1. The voluntary consent of the human subject is absolutely essential. The person involved should have legal capacity to give consent; should be so situated as to be able to…
Timothy M. Pawlik and Julie A. Sosa (eds.)Success in Academic SurgerySuccess in Academic Surgery: Clinical Trials201410.1007/978-1-4471-4679-7_6 © Springer-Verlag London 2014 6. Planning for Data Monitoring and Audits Lisa Jacobs1 (1) Department of Surgery, Johns Hopkins University,…
Fig. 3.1 Power curve. A power curve demonstrates the increasing differences (δ) between the control group and the intervention group with a one-sided significance level of 0.05 and a total…
Fig. 7.1 Steps for submitting the NIH budget 7.3 Complying with Federal Cost Principles For a grant to be accepted by the NIH, not only should it be scientifically sound…
Fig. 1.1 Members of the clinical trial research team (IRB institutional review board, Co–PI coprincipal investigator) 1.2 Key Members of the Clinical Trial Research Team 1.2.1 Principal Investigator The principal…
