Regulatory Considerations in Human Subjects Research
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…
Planning for Data Monitoring and Audits
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,…
The Budget
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…
Building Your Clinical Trial Research Team
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…
