ACRP CCRC 2024 FINAL EXAM 300
QUESTIONS WITH DETAILED
VERIFIED AND 100% CORRECT
ANSWERS BRAND NEW EXAM
ALREADY GRADED A+
What type of risk-based inspection involves the selection
of a number of clinical trials for the inspection sample? -
....ANSWER...Routine National Systems Inspections
True or False? Globalization of clinical research is a
major factor that's led to development of a common and
accepted framework and sharing of inspection
observations in different regions. - ....ANSWER...True
The FRD CDER published information about inspection
site selection tools that takes into account what three
levels of risk attributes? -
....ANSWER...Application level, study level, clinical site
level
Factors that influence GCP inspection selection process
include? - ....ANSWER...- The number of UK patients
and nature of subjects
1
,- Outcome of previous GCP inspections
- Organization with no inspection history
True or False? Concerns about accuracy of submitted
data can include an unusual recruitment pattern. -
....ANSWER...True
True or False? For the EMA, inspections are conducted
by the EMA inspectorate of the EU. -
....ANSWER...False
True or False? Comprehensive data management plans
can help ensure the recording of accurate and complete
data. - ....ANSWER...True
True or False? Regulatory investigators must have
rights/privileges granted for electronic record systems. -
....ANSWER...True
Current coordinator is asked a question about the
enrollment source completed by prior coordinator during
regulatory inspection. What should her response be if
she knows the correct answer? -
....ANSWER...Decline answer as she has no first hand
knowledge of the creation of source document
Documents that may be inspected to show the sponsors
2
,oversight of trial may include: -
3
, ....ANSWER...- Documents that describe transfer of
obligations
- Investigator/site qualifications/selection process and
training
- Monitoring plans, reports and corrective actions
through the monitoring process
What are expected or possible consequences of
over-estimation of recruitment potential? -
....ANSWER...- The trial will overrun its projected
timeline
- The recruitment period will be prolonged and more
sites may be needed
- The study will not have sufficient data within the
required timeframe and will be stopped because of lack
of budget
What should be the first consideration when conducting
a clinical trial? - ....ANSWER...Subject welfare
When is the investigator allowed to deviate from the
protocol? - ....ANSWER...When there is an immediate
hazard to a patient.
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