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