Statistics: Setting the Stage
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…
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…
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…
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…
