ICH ACRP STUDY GUIDE

LAR - Answer- Legally Authorized Representative Essential documents - Answer- documents which individually and collectively permit evaluation of the conduct of a study and quality of the data produced Who developed the Declaration of Helsinky? - Answer- the World Medical Association Phase 1 study - Answer- designed to determine the metabolic and pharmacologic action of the drug in humans monitor - Answer- ultimately responsible for source data verification investigator - Answer- leader of the research team who is responsible for the conduct of the clinical trial at the trial site sponsor - Answer- individual, company, institution or organization which takes responsibility for initiation, management and/or financing of a clinical trial purpose of initiation visit - Answer- to review protocol, SOPs, and blank CRFs purpose of IRB/IEC - Answer- to protect subject safety purpose of source documentation - Answer- to document the existence of study participants and substantiate the integrity of the study data collected DSMB - Answer- data and safety monitoring board purpose of DSMB - Answer- to assess the progress of a clinical trial, safety data, and critical efficacy endpoints sponsor - Answer- responsible for providing the trial protocol phase 4 study - Answer- designed for therapeutic use, begins after drug approval GCP - Answer- international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects Phase 3 study - Answer- determines therapeutic benefit and is usually conducted in larger, specific population Declaration of Helsinki - Answer- WMA ethical principles for medical research involving human subjects Informed