ACRP CP FINAL EXAM QUESTIONS WITH COMPLETE SOLUTIONS
GUARANTEED PASS BRAND NEW 2026
Adverse Drug Reaction (ADR) - ANSWER..> - All noxious and
unintended response that is related to any dose
- If the reaction is possibly, probably, or definitely related to the
drug, it is considered an ADR
- All ADRs must be documented
- ADRs are not always AEs
Unexpected Event - ANSWER..> Not observed before. Or the
Event occurred more often than previously observed
Adverse Event (AE) - ANSWER..> - Any untoward medical
occurrence that does not necessarily have a causal relationship
with treatment.
, - Can be mild moderate or severe
- Worsening of a pre-existing medical condition is an AE
Non-Clinical Study - ANSWER..> - Not conducted on human
subjects. -Provide preliminary safety and pharmacokinetic data
needed to support studies in human
Data Safety and Monitoring Board (DSMB) - ANSWER..> -
Assesses the progress of a clinical trial, the safety data, and the
critical efficacy endpoints
- Can recommend that sponsors modify, end, or continue a
trial. But cannot recommend they start a new trial
WMA - ANSWER..> World Medical Association
Declaration of Helsinki - ANSWER..> -Created by WMA in
1964 - Defines the ethical principles for medical research
involving human subjects i.e.:
1. Importance of ICF Requirement of ethical review and
approval of research before it is undertaken
2. Acknowledgement and guidance of special protections for
vulnerable subjects
3. Recommends trials are registered on public database
LAR - ANSWER..> Legally Acceptable Representative. (regarding
consenting procedures)
GUARANTEED PASS BRAND NEW 2026
Adverse Drug Reaction (ADR) - ANSWER..> - All noxious and
unintended response that is related to any dose
- If the reaction is possibly, probably, or definitely related to the
drug, it is considered an ADR
- All ADRs must be documented
- ADRs are not always AEs
Unexpected Event - ANSWER..> Not observed before. Or the
Event occurred more often than previously observed
Adverse Event (AE) - ANSWER..> - Any untoward medical
occurrence that does not necessarily have a causal relationship
with treatment.
, - Can be mild moderate or severe
- Worsening of a pre-existing medical condition is an AE
Non-Clinical Study - ANSWER..> - Not conducted on human
subjects. -Provide preliminary safety and pharmacokinetic data
needed to support studies in human
Data Safety and Monitoring Board (DSMB) - ANSWER..> -
Assesses the progress of a clinical trial, the safety data, and the
critical efficacy endpoints
- Can recommend that sponsors modify, end, or continue a
trial. But cannot recommend they start a new trial
WMA - ANSWER..> World Medical Association
Declaration of Helsinki - ANSWER..> -Created by WMA in
1964 - Defines the ethical principles for medical research
involving human subjects i.e.:
1. Importance of ICF Requirement of ethical review and
approval of research before it is undertaken
2. Acknowledgement and guidance of special protections for
vulnerable subjects
3. Recommends trials are registered on public database
LAR - ANSWER..> Legally Acceptable Representative. (regarding
consenting procedures)
