ACRP CP CERTIFICATION EXAM LATEST VERSION 2024 WITH
DETAILED QUESTIONS AND 100% CORRECT ANSWERS
Who is responsible for providing the protocol - CORRECT ANSWER The Sponsor
The purpose of the SIV is to - CORRECT ANSWER1. review standard procedures
2. review the protocol
3. review the blank eCRFs: Minimum SAE reporting requirements
4. Subject details (ID not name)
5. IP
6. Interventions for the event that is being reported
7. Details of the event
8. Details on the reporter of the event
9. Admin and sponsor or company details
Vulnerable subjects - CORRECT ANSWER1. Junior members of the medical profession
2. Employees of a pharmaceutical company
3. Military personnel
4. Pregnant Women
5. Prisoners
IRB/IEC Evaluates - CORRECT ANSWER1. The rights: safety: and well-being of the
subjects participating in the trial
2. The subject selection procedure
3. The scientific tenability of the trial
Serious Adverse Event (SAE) - CORRECT ANSWER1. Results in death: is life
threatening
2. Requires inpatient admission
3. Prolonged admission
4. Congenital anomaly
5. Persistent incapacity
6. Death itself is not necessarily an SAE*
7. Must be reported by sponsor to authorities within 15 calendars days from sponsors
first knowledge of the event
*Seriousness does not equal severity in that Serious requires reporting while severe
may not.. Severe may just be used to describe an AE
Adverse Drug Reaction (ADR) - CORRECT ANSWER1. All noxious and unintended
response that is related to any dose
2. If the reaction is possibly: probably: or definitely related to the drug: it is considered
an ADR
3. All ADRs must be documented
,4. ADRs are not always AEs
Not observed before. Or the Event occurred more often than previously observed -
CORRECT ANSWER Unexpected Event
Adverse Event (AE) - CORRECT ANSWER1. Any untoward medical occurrence that
does not necessarily have a causal relationship with treatment
2. Can be mild moderate or severe
3. Worsening of a pre-existing medical condition is an AE
Non-Clinical Study - CORRECT ANSWER1. Not conducted on human subjects
2. Provide preliminary safety and pharmacokinetic data needed to support studies in
human
Data Safety and Monitoring Board (DSMB) - CORRECT ANSWER1. Assesses the
progress of a clinical trial: the safety data: and the critical efficacy endpoints
2. Can recommend that sponsors modify: end: or continue a trial. But cannot
recommend they start a new trial
WMA - CORRECT ANSWER World Medical Association
Declaration of Helsinki - CORRECT ANSWER-Created by WMA in 1964: - Defines the
ethical principles for medical research involving human subjects
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 - CORRECT ANSWER Legally Acceptable Representative. (regarding consenting
procedures)
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 ANSWER1. IP accountability records
2. Subject screening log
3. 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 CRA be filed? - CORRECT ANSWER in the Sponsor's files
During a multi-site clinical study: Whose responsibility is it to report subject recruitment
rate? - CORRECT ANSWERCRA (Monitor)
What is the investigator's first priority when a subject wishes to withdraw prematurely
from the trial? - CORRECT ANSWER to obtain the subject's reason for withdrawal
CRC's can't adjust IP dose: even if they are a qualified physician (T/F) - CORRECT
ANSWER False. If a CRC is a qualified physician, they can adjust IP dose
Following unbinding in the case of a suspected serious unexpected adverse drug
reaction: the treatment assigned to the subject turns out to be the comparator product.
Who should the sponsor inform? - CORRECT ANSWER The manufacturer of the
product and/or the regulatory authorities
If there is a a serious unexpected adverse drug reaction in a blinded trial: when should
the investigator unbind the subject? - CORRECT ANSWER The investigator unblinds
before reporting the SUADR: in order to determine a safe treatment
DETAILED QUESTIONS AND 100% CORRECT ANSWERS
Who is responsible for providing the protocol - CORRECT ANSWER The Sponsor
The purpose of the SIV is to - CORRECT ANSWER1. review standard procedures
2. review the protocol
3. review the blank eCRFs: Minimum SAE reporting requirements
4. Subject details (ID not name)
5. IP
6. Interventions for the event that is being reported
7. Details of the event
8. Details on the reporter of the event
9. Admin and sponsor or company details
Vulnerable subjects - CORRECT ANSWER1. Junior members of the medical profession
2. Employees of a pharmaceutical company
3. Military personnel
4. Pregnant Women
5. Prisoners
IRB/IEC Evaluates - CORRECT ANSWER1. The rights: safety: and well-being of the
subjects participating in the trial
2. The subject selection procedure
3. The scientific tenability of the trial
Serious Adverse Event (SAE) - CORRECT ANSWER1. Results in death: is life
threatening
2. Requires inpatient admission
3. Prolonged admission
4. Congenital anomaly
5. Persistent incapacity
6. Death itself is not necessarily an SAE*
7. Must be reported by sponsor to authorities within 15 calendars days from sponsors
first knowledge of the event
*Seriousness does not equal severity in that Serious requires reporting while severe
may not.. Severe may just be used to describe an AE
Adverse Drug Reaction (ADR) - CORRECT ANSWER1. All noxious and unintended
response that is related to any dose
2. If the reaction is possibly: probably: or definitely related to the drug: it is considered
an ADR
3. All ADRs must be documented
,4. ADRs are not always AEs
Not observed before. Or the Event occurred more often than previously observed -
CORRECT ANSWER Unexpected Event
Adverse Event (AE) - CORRECT ANSWER1. Any untoward medical occurrence that
does not necessarily have a causal relationship with treatment
2. Can be mild moderate or severe
3. Worsening of a pre-existing medical condition is an AE
Non-Clinical Study - CORRECT ANSWER1. Not conducted on human subjects
2. Provide preliminary safety and pharmacokinetic data needed to support studies in
human
Data Safety and Monitoring Board (DSMB) - CORRECT ANSWER1. Assesses the
progress of a clinical trial: the safety data: and the critical efficacy endpoints
2. Can recommend that sponsors modify: end: or continue a trial. But cannot
recommend they start a new trial
WMA - CORRECT ANSWER World Medical Association
Declaration of Helsinki - CORRECT ANSWER-Created by WMA in 1964: - Defines the
ethical principles for medical research involving human subjects
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 - CORRECT ANSWER Legally Acceptable Representative. (regarding consenting
procedures)
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 ANSWER1. IP accountability records
2. Subject screening log
3. 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 CRA be filed? - CORRECT ANSWER in the Sponsor's files
During a multi-site clinical study: Whose responsibility is it to report subject recruitment
rate? - CORRECT ANSWERCRA (Monitor)
What is the investigator's first priority when a subject wishes to withdraw prematurely
from the trial? - CORRECT ANSWER to obtain the subject's reason for withdrawal
CRC's can't adjust IP dose: even if they are a qualified physician (T/F) - CORRECT
ANSWER False. If a CRC is a qualified physician, they can adjust IP dose
Following unbinding in the case of a suspected serious unexpected adverse drug
reaction: the treatment assigned to the subject turns out to be the comparator product.
Who should the sponsor inform? - CORRECT ANSWER The manufacturer of the
product and/or the regulatory authorities
If there is a a serious unexpected adverse drug reaction in a blinded trial: when should
the investigator unbind the subject? - CORRECT ANSWER The investigator unblinds
before reporting the SUADR: in order to determine a safe treatment
