Citi Good Clinical Practice Course Questions And Answers 100% Verified A+ Guaranteed

Pharmacodynamics {Ans: the use of genetic information to predict whether a drug will help make a patient well or ill}Audit {Ans: systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)}Serious Adverse Event (SAE) or Serious Suspected Adverse Reactions {Ans: adverse events where the subject outcome is death, life-threatening (substantial risk of dying at the time of the adverse event or continued use might have resulted in death), inpatient hospitalization or an extension of an existing hospitalization, disability or permanent damage (substantial disruption of the ability to conduct normal life functions), congenital anomaly/birth defect, or required intervention to prevent permanent impairment, or otherwise serious (does not fit other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes}Class II devices {Ans: moderate risk devices and are subject to both general controls and special controls such as specific FDA performance standards, post-market surveillance, or special control guidance to ensure their