ACRP CP FINAL EXAM LATEST 2024
REAL EXAM 150 QUESTIONS AND
CORRECT ANSWERS|AGRADE
Crossover - Answer-when each subject is randomized to a sequence of two or more
treatments and hence acts as their own control for treatment comparisons
/.Parallel - Answer-when subjects are randomized to 1 of 2 or more arms, each arm
being allocated a different treatment. Each treatment will include their investigational
product at one or more doses, and one or more control treatments, such as placebo
and/or an active comparator
/.A sponsor is developing an IP for treatment of a medical condition where there is one
additional marketed product approved for treatment of the condition. The sponsor
believes their product works as well or better than the current treatment with fewer side
effects. What is the most-likely study design they will use to test the efficacy of the IP? -
Answer-Non-Inferiority
/.What type of clinical trial most likely requires enrollment of the largest number of
research subjects? - Answer-Therapeutic confirmatory (aka Pivotal Trial, Ph III, or
Comparative Efficacy)
/.Minimum number of membors on an IRB/IEC - Answer-5 .. lay people and medical
professionals can be part of the IRB/IEC
/.Who is responsible for providing the protocol - Answer-The Sponsor
/.The purpose of the SIV is to - Answer--review standard procedures
-review the protocol
-review the blank eCRFs
/.Minimum SAE reporting requirements - Answer-- Subject details (ID not name)
- IP
- Interventions for the event that is being reported
- Details of the event
- Details on the reporter of the event
- Admin and sponsor or company details/
/.Vulnerable subjects - Answer-- Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
, /.IRB/IEC Evaluates - Answer-- The rights, safety, and well-being of the subjects
participating in the trial
- The subject selection procedure
- The scientific tenability of the trial
/.Serious Adverse Event (SAE) - Answer-- results in death, is life threatening, requires
inpatient admission, prolonged admission, congenital anomaly, or persistent incapacity
-death itself is not neccessarily an sae
- Seriousness does not equal severity in that Serious requires reporting while severe
may not.. Severe may just be used to describe an AE
- Must be reported by sponsor to authorities within 15 calendars days from sponsors
first knowledge of the event
/.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
REAL EXAM 150 QUESTIONS AND
CORRECT ANSWERS|AGRADE
Crossover - Answer-when each subject is randomized to a sequence of two or more
treatments and hence acts as their own control for treatment comparisons
/.Parallel - Answer-when subjects are randomized to 1 of 2 or more arms, each arm
being allocated a different treatment. Each treatment will include their investigational
product at one or more doses, and one or more control treatments, such as placebo
and/or an active comparator
/.A sponsor is developing an IP for treatment of a medical condition where there is one
additional marketed product approved for treatment of the condition. The sponsor
believes their product works as well or better than the current treatment with fewer side
effects. What is the most-likely study design they will use to test the efficacy of the IP? -
Answer-Non-Inferiority
/.What type of clinical trial most likely requires enrollment of the largest number of
research subjects? - Answer-Therapeutic confirmatory (aka Pivotal Trial, Ph III, or
Comparative Efficacy)
/.Minimum number of membors on an IRB/IEC - Answer-5 .. lay people and medical
professionals can be part of the IRB/IEC
/.Who is responsible for providing the protocol - Answer-The Sponsor
/.The purpose of the SIV is to - Answer--review standard procedures
-review the protocol
-review the blank eCRFs
/.Minimum SAE reporting requirements - Answer-- Subject details (ID not name)
- IP
- Interventions for the event that is being reported
- Details of the event
- Details on the reporter of the event
- Admin and sponsor or company details/
/.Vulnerable subjects - Answer-- Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
, /.IRB/IEC Evaluates - Answer-- The rights, safety, and well-being of the subjects
participating in the trial
- The subject selection procedure
- The scientific tenability of the trial
/.Serious Adverse Event (SAE) - Answer-- results in death, is life threatening, requires
inpatient admission, prolonged admission, congenital anomaly, or persistent incapacity
-death itself is not neccessarily an sae
- Seriousness does not equal severity in that Serious requires reporting while severe
may not.. Severe may just be used to describe an AE
- Must be reported by sponsor to authorities within 15 calendars days from sponsors
first knowledge of the event
/.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
