ACRP CP Proficiency knowledge test Exam Questions and certified Answers 2024/2025
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Course
ACRP-CP
Institution
ACRP-CP
ACRP CP Proficiency knowledge test Exam Questions and certified Answers 2024/2025
What is a source document? - correct answer Any data, document or record created as first point of data entry. This all counts as certified copies
What is an Adverse Event? - correct answer Undesirable medic...
ACRP CP Proficiency knowledge test Exam
Questions and certified Answers 2024/2025
What is a source document? - correct answer Any data,
document or record created as first point of data entry. This all
counts as certified copies
What is an Adverse Event? - correct answer Undesirable
medical condition or worsening of preexisting condition.
What is an expected AE? - correct answer Any adverse event
that is consistent with applicable product info or that has been
reported on previous trials.
What does an IRB evaluate? - correct answer - The rights,
safety and well being of subjects
- subject selection procedures
- scientific tenability of a study
Describe IRB members - correct answer - 5 members
- 1 cannot be affiliated with institution
- 1 must be concerned with non scientific
- cannot all be MDs
Define a SUA - correct answer Any SAE that is unexpected and
cannot be found in the IB or drug label.
, Also referred to as the SUSAR
What is an AESI - correct answer - An adverse event of special
interest
- cannot be serious or non serious
- has a concern specific to sponsors product
- requires ongoing monitoring & further investigation
Which 4 documents must be reviewed by IRB - correct answer
- protocol
- investigational brochure
- sample consent form
- all advertising
What is the timeframe for sponsor to report FATAL SAE? -
correct answer 7 days. 15 days if written. Must be reported to
FDA (regulatory authority)
Define contemperaneous - correct answer - Existing or
occurring in the same period of time
- data is only credible if recorded and documented at the time of
action
True or False: If you suspend or terminate your own study, you
must notify the IRB - correct answer True
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