ACRP CP Exam ACTUAL UPDATED
Questions and CORRECT Answers
Crossover - CORRECT ANSWERS when each subject is randomized to a sequence of two
or more treatments and hence acts as their own control for treatment comparisons
Parallel - CORRECT ANSWERS 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? - CORRECT ANSWERS Non-
Inferiority
What type of clinical trial most likely requires enrollment of the largest number of research
subjects? - CORRECT ANSWERS Therapeutic confirmatory (aka Pivotal Trial, Ph III, or
Comparative Efficacy)
Minimum number of membors on an IRB/IEC - CORRECT ANSWERS 5 .. lay people
and medical professionals can be part of the IRB/IEC
Who is responsible for providing the protocol - CORRECT ANSWERS The Sponsor
The purpose of the SIV is to - CORRECT ANSWERS -review standard procedures
-review the protocol
-review the blank eCRFs
Minimum SAE reporting requirements - CORRECT ANSWERS - 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 - CORRECT ANSWERS - Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
IRB/IEC Evaluates - CORRECT ANSWERS - 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) - CORRECT ANSWERS - 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) - CORRECT ANSWERS - 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
Questions and CORRECT Answers
Crossover - CORRECT ANSWERS when each subject is randomized to a sequence of two
or more treatments and hence acts as their own control for treatment comparisons
Parallel - CORRECT ANSWERS 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? - CORRECT ANSWERS Non-
Inferiority
What type of clinical trial most likely requires enrollment of the largest number of research
subjects? - CORRECT ANSWERS Therapeutic confirmatory (aka Pivotal Trial, Ph III, or
Comparative Efficacy)
Minimum number of membors on an IRB/IEC - CORRECT ANSWERS 5 .. lay people
and medical professionals can be part of the IRB/IEC
Who is responsible for providing the protocol - CORRECT ANSWERS The Sponsor
The purpose of the SIV is to - CORRECT ANSWERS -review standard procedures
-review the protocol
-review the blank eCRFs
Minimum SAE reporting requirements - CORRECT ANSWERS - 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 - CORRECT ANSWERS - Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
IRB/IEC Evaluates - CORRECT ANSWERS - 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) - CORRECT ANSWERS - 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) - CORRECT ANSWERS - 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
