ACRP-CP Exam |2024 UPDATE |ACTUAL
EXAM QUESTIONS AND VERIFIED
ANSWERS/ACCURATE SOLUTIONS |GET IT
100% CORRECT!! ALREADY GRADED A+
ADR - answer-Adverse Drug Reaction
Audit - answer-Reviews how the research was conducted; takes into account
SOPs, IRB requirements & GCP (ensures compliance)
Audit Certificate - answer-Confirmation audit took place
Audit Report - answer-Written Evaluation - not regularly made available to
regulatory body; only when serious evidence exists concerning non-compliance
Global Variables - answer-These assess the overall outcomes in objective
terms. The PI may give impressions regarding the study
,Surrogate variable - answer-kind of fill in for other variables and are pretty
general
Methods to avoid bias - answer-blinding
randomization
Parallel Trial Design - answer-Study Group ----------------> END
Control Group --------------> END
Crossover Trial Design - answer-Study Group ----------> Control Group ------>
END
Control Group --------> Study Group ------> END
*main issue is ample wash out time b/w crossovers
Factorial Design - answer-Evaluates two or more treatments simultaneously
*Drug A
*Drug B
*Drug A & B
*Neither Drug A or B
Blood pressure - answer-Systolic/Diastolic
LFTs - answer-Liver Function Tests
Total Protein
,Albumin
Bilirubin
ALP (Alk Phos)
AST/ALT
Peak - answer-Varies, but usually around 30 mins to several hours after dosing,
depends on administration
Kidney Function - answer-BUN (urea nitrogen)
Creatinine
Nuremburg Code - answer-The voluntary consent of the human subject is
absolutely essential
Date/time on ICF - answer-only date is required; time is generally preferred by
PIs
Audit Trail - answer-Documentation of audit events
Single Blind Study - answer-Subjects Unaware
Double Blind Study - answer-Subjects & Researchers are unaware
, Comparator - answer-Item used as an active control references in a clinical trail
Coordinating Committee - answer-Group a sponsor comprises to coordinate
multi-center trials
Coordinating Investigator - answer-An investigator who oversees multiple sites
of a clinical trial (multicenter)
IDMC - answer-Independent Data Monitoring Committee, Data & Safety
Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety &
progress; make recommendations to continue, modify or stop
IEC - answer-Independent Ethics Committee; group who oversees protection,
rights, safety & well-being of human subjects
Investigator's Brochure - answer-Compilation of data on an investigational
product used in human subjects
Legally acceptable representative - answer-person whom is lawfully able to
consent on behalf of another
SAE - answer-Serious Adverse Event - Results in death, is life-threatening,
requires long-term hospitalization, results in long term
disability/hospitalization incapacitation or is a congenital birth defect
EXAM QUESTIONS AND VERIFIED
ANSWERS/ACCURATE SOLUTIONS |GET IT
100% CORRECT!! ALREADY GRADED A+
ADR - answer-Adverse Drug Reaction
Audit - answer-Reviews how the research was conducted; takes into account
SOPs, IRB requirements & GCP (ensures compliance)
Audit Certificate - answer-Confirmation audit took place
Audit Report - answer-Written Evaluation - not regularly made available to
regulatory body; only when serious evidence exists concerning non-compliance
Global Variables - answer-These assess the overall outcomes in objective
terms. The PI may give impressions regarding the study
,Surrogate variable - answer-kind of fill in for other variables and are pretty
general
Methods to avoid bias - answer-blinding
randomization
Parallel Trial Design - answer-Study Group ----------------> END
Control Group --------------> END
Crossover Trial Design - answer-Study Group ----------> Control Group ------>
END
Control Group --------> Study Group ------> END
*main issue is ample wash out time b/w crossovers
Factorial Design - answer-Evaluates two or more treatments simultaneously
*Drug A
*Drug B
*Drug A & B
*Neither Drug A or B
Blood pressure - answer-Systolic/Diastolic
LFTs - answer-Liver Function Tests
Total Protein
,Albumin
Bilirubin
ALP (Alk Phos)
AST/ALT
Peak - answer-Varies, but usually around 30 mins to several hours after dosing,
depends on administration
Kidney Function - answer-BUN (urea nitrogen)
Creatinine
Nuremburg Code - answer-The voluntary consent of the human subject is
absolutely essential
Date/time on ICF - answer-only date is required; time is generally preferred by
PIs
Audit Trail - answer-Documentation of audit events
Single Blind Study - answer-Subjects Unaware
Double Blind Study - answer-Subjects & Researchers are unaware
, Comparator - answer-Item used as an active control references in a clinical trail
Coordinating Committee - answer-Group a sponsor comprises to coordinate
multi-center trials
Coordinating Investigator - answer-An investigator who oversees multiple sites
of a clinical trial (multicenter)
IDMC - answer-Independent Data Monitoring Committee, Data & Safety
Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety &
progress; make recommendations to continue, modify or stop
IEC - answer-Independent Ethics Committee; group who oversees protection,
rights, safety & well-being of human subjects
Investigator's Brochure - answer-Compilation of data on an investigational
product used in human subjects
Legally acceptable representative - answer-person whom is lawfully able to
consent on behalf of another
SAE - answer-Serious Adverse Event - Results in death, is life-threatening,
requires long-term hospitalization, results in long term
disability/hospitalization incapacitation or is a congenital birth defect
