ICH ACRP Exam Questions with 100%
Correct Answers
Lar correct answer legally authorized representative
Essential documents correct 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? Correct answer the world medical
association
Phase 1 study correct answer designed to determine the metabolic and pharmacologic
action of the drug in humans
Monitor correct answer ultimately responsible for source data verification
Investigator correct answer leader of the research team who is responsible for the
conduct of the clinical trial at the trial site
Sponsor correct answer individual, company, institution or organization which takes
responsibility for initiation, management and/or financing of a clinical trial
Purpose of initiation visit correct answer to review protocol, sops, and blank crfs
Purpose of irb/iec correct answer to protect subject safety
Purpose of source documentation correct answer to document the existence of study
participants and substantiate the integrity of the study data collected
Dsmb correct answer data and safety monitoring board
Purpose of dsmb correct answer to assess the progress of a clinical trial, safety data,
and critical efficacy endpoints
Sponsor correct answer responsible for providing the trial protocol
Phase 4 study correct answer designed for therapeutic use, begins after drug approval
Gcp correct answer international ethical and scientific quality standard for designing,
conducting, recording, and reporting trials that involve human subjects
Phase 3 study correct answer determines therapeutic benefit and is usually conducted
in larger, specific population
Correct Answers
Lar correct answer legally authorized representative
Essential documents correct 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? Correct answer the world medical
association
Phase 1 study correct answer designed to determine the metabolic and pharmacologic
action of the drug in humans
Monitor correct answer ultimately responsible for source data verification
Investigator correct answer leader of the research team who is responsible for the
conduct of the clinical trial at the trial site
Sponsor correct answer individual, company, institution or organization which takes
responsibility for initiation, management and/or financing of a clinical trial
Purpose of initiation visit correct answer to review protocol, sops, and blank crfs
Purpose of irb/iec correct answer to protect subject safety
Purpose of source documentation correct answer to document the existence of study
participants and substantiate the integrity of the study data collected
Dsmb correct answer data and safety monitoring board
Purpose of dsmb correct answer to assess the progress of a clinical trial, safety data,
and critical efficacy endpoints
Sponsor correct answer responsible for providing the trial protocol
Phase 4 study correct answer designed for therapeutic use, begins after drug approval
Gcp correct answer international ethical and scientific quality standard for designing,
conducting, recording, and reporting trials that involve human subjects
Phase 3 study correct answer determines therapeutic benefit and is usually conducted
in larger, specific population
