ICH ACRP Exam Questions With Verified Solutions

ICH ACRP Exam Questions With Verified Solutions LAR - answerLegally Authorized Representative Essential documents - answerdocuments which individually and collectively permit evaluation of the conduct of a study and quality of the data produced Who developed the Declaration of Helsinky? - answerthe World Medical Association Phase 1 study - answerdesigned to determine the metabolic and pharmacologic action of the drug in humans monitor - answerultimately responsible for source data verification investigator - answerleader of the research team who is responsible for the conduct of the clinical trial at the trial site sponsor - answerindividual, company, institution or organization which takes responsibility for initiation, management and/or financing of a clinical trial purpose of initiation visit - answerto review protocol, SOPs, and blank CRFs purpose of IRB/IEC - answerto protect subject safety purpose of source documentation - answerto document the existence of study participants and substantiate the integrity of the study data collected DSMB - answerdata and safety monitoring board purpose of DSMB - answerto assess the progress of a clinical trial, safety data, and critical efficacy endpoints sponsor - answerresponsible for providing the trial protocol phase 4 study - answerdesigned for therapeutic use, begins after drug approval GCP - answerinternational ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects Phase 3 study - answerdetermines therapeutic benefit and is usually conducted in larger, specific population