ACRP Practice Exam Questions and Answers
100% Correct
Adverse Drug Reaction (ADR) - 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 Not observed before. Or the
Event occurred more often than previously observed
Adverse Event (AE) - 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 - Not conducted on human subjects.
-Provide preliminary safety and pharmacokinetic data needed to support studies in human
,Data Safety and Monitoring Board (DSMB) - 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 World Medical Association
Declaration of Helsinki -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 Legally Acceptable Representative. (regarding consenting procedures)
International Conference on Harmonization (ICH) Mission is to provide a unified standard
for Europe, US, and Japan to facilitate the acceptance of clinical trials
, Expected AEs Those that are consistent with the product information and were present on
previous and preclinical trials
Contents of the site TMF - 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 at least 3 years
The signature page is an optional section of the IB (T/F) True
Incapacitated subjects can provide consent as soon as capacity is regained (T/F) True
Who should send Annual Progress Reports to the IRB/IEC The Investigator
The investigator is required to share names of subjects with the IRB/IEC (T/F) False
100% Correct
Adverse Drug Reaction (ADR) - 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 Not observed before. Or the
Event occurred more often than previously observed
Adverse Event (AE) - 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 - Not conducted on human subjects.
-Provide preliminary safety and pharmacokinetic data needed to support studies in human
,Data Safety and Monitoring Board (DSMB) - 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 World Medical Association
Declaration of Helsinki -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 Legally Acceptable Representative. (regarding consenting procedures)
International Conference on Harmonization (ICH) Mission is to provide a unified standard
for Europe, US, and Japan to facilitate the acceptance of clinical trials
, Expected AEs Those that are consistent with the product information and were present on
previous and preclinical trials
Contents of the site TMF - 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 at least 3 years
The signature page is an optional section of the IB (T/F) True
Incapacitated subjects can provide consent as soon as capacity is regained (T/F) True
Who should send Annual Progress Reports to the IRB/IEC The Investigator
The investigator is required to share names of subjects with the IRB/IEC (T/F) False
