ACRP CP Learning checks Exam Questions with complete Answers 2024/2025
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Course
ACRP-CP
Institution
ACRP-CP
ACRP CP Learning checks Exam Questions with complete Answers 2024/2025
Randomization - correct answer method used to Equify distribution of tx to subjects; to eliminate bias
Stratification - correct answer method used to control assignment based on variables; like disease status; allows balan...
ACRP CP Learning checks Exam Questions
with complete Answers 2024/2025
Randomization - correct answer method used to Equify
distribution of tx to subjects; to eliminate bias
Stratification - correct answer method used to control
assignment based on variables; like disease status; allows
balanced comparability
Pk studies - correct answer involves taking several blood
samples over a period of time to determine how the body handles
the substance
Ide - correct answer investigational device exemption; to
administer an investigational drug or biological product to
humans
Gcp - correct answer standard for designing, conducting, and
reporting clinical trials; to make sure data is acurate, and to
make sure the rights, integrity and confidentiality of patient is
protected.
Ich gcp requirements before accepting a protocol - correct
answer - potential to recruit proper number of patients
- enough time to conduct trial
- adequate staff
- adequate facility.
, Regulatory compliance - correct answer qa/qc requirements,
data collection and reporting requirements, source data access
and verification
Importance of subject stipend: - correct answer must be
approved by irb to make sure the timing and amount is not
coercive nor influences the subject
1571 ` - correct answer ind application; permit to do research
on humans for the first time; has background info; and rationale;
updated annually
1572 - correct answer investigator statement; commitment,
done nationally and internationally by sponsors intending to hava
marketing aproval for ip
Ib - correct answer clinical and non-clinical data on the
investigational product that is relevant to the study in human
subjects; supplied prior to regulatory approval
Study type - open label - correct answer everyone knows the
treatment
Study type - single blind - correct answer one party knows tx,
usually the patient does not know but the monitoring team does
Study type - double blind - correct answer 2 or more people are
blinded, usually the patient and monitoring tram do not know
which drug is given.
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