ACRP-CP Actual preparation test exam with Thorough and Correct Answers Updated 2024/2025
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Course
ACRP-CP
Institution
ACRP-CP
ACRP-CP Actual preparation test exam with Thorough and Correct Answers Updated 2024/2025
International Conference on Harmonization (ICH) - correct answer Mission is to provide a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials
Expected AEs - correc...
ACRP-CP Actual preparation test exam with
Thorough and Correct Answers Updated
2024/2025
International Conference on Harmonization (ICH) - correct
answer Mission is to provide a unified standard for Europe,
US, and Japan to facilitate the acceptance of clinical trials
Expected AEs - correct answer Those that are consistent with
the product information and were present on previous and
preclinical trials
Contents of the site TMF - correct answer - IP accountability
records
- Subject screening log
- Signed ICFs
Per ICH, how long must an IRB/IEC keep correspondence for
after the completion of a clinical trial - correct answer at least
3 years
The signature page is an optional section of the IB (T/F) -
correct answer True
Incapacitated subjects can provide consent as soon as capacity is
regained (T/F) - correct answer True
, Who should send Annual Progress Reports to the IRB/IEC -
correct answer The Investigator
The investigator is required to share names of subjects with the
IRB/IEC (T/F) - correct answer False
CRAs(monitors) cannot review source documents of subjects who
have withdrawn consent. Even if the source document predates
their consent withdrawal(T/F) - correct answer True
When should research studies involving human subjects be
registered in a publicly accessible database - correct answer
before recruiting the first subject
Any changes to safety language in an IB should be submitted to
the IRB/IEC (T/F) - correct answer True
All SAE's must be life-threatening to be considered an SAE
opposed to AE (T/F) - correct answer True
After completion of a study, where should the final trial close-out
monitoring report prepared by the CRAbe filed - correct answer
in the Sponsor's files
During a multi-site clinical study, Whose responsibility is it to
report subject recruitment rate - correct answer CRA
(Monitor)
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