ACRP CP Review Questions with Verified
Correct Answers
What is the process by which a subject voluntarily confirms their willingness to
participate in a clinical trial?
Informed consent
Where are a research subject's responsibilities for study participation described?
Informed Consent Form (ICF)
An unconscious subject was enrolled with consent from a Legally Acceptable
Representative (LAR) and later regains consciousness. What should the investigator
do?
Inform the subject about the study and obtain the subject's consent to continue participation.
When is an impartial witness required during informed consent?
When the subject or LAR cannot read (e.g., illiterate subject).
Who must sign the informed consent form?
1. The subject or legally authorized representative
2. The person who conducted the consent discussion
A study has no anticipated direct benefit to participants. What should the ICF state?
That no expected benefit is anticipated.
What increases the risk of coercion during consent?
Obtaining consent in the presence of a figure of authority.
What is assent?
, A child's affirmative agreement to participate in research.
What is the primary purpose of an IRB/IEC?
To safeguard the rights, safety, and well-being of research participants.
What is the minimum number of IRB members?
5
An IRB should include what types of members?
1. At least one non-scientific member
2. At least one member independent of the institution
3. Members with appropriate scientific and ethical expertise
How long must an IRB retain records after completion of a clinical trial?
At least 3 years
Who submits annual progress reports to the IRB?
The investigator
Who has ultimate responsibility for all research conducted at a site?
The Principal Investigator (PI).
What should an investigator determine before agreeing to participate in a trial?
Whether enough eligible patients are available for enrollment.
When a subject wants to withdraw from a study, what should the investigator do first?
Attempt to determine the reason for withdrawal while respecting the subject's decision.
Who is responsible for reporting significant new safety information to participants?
Correct Answers
What is the process by which a subject voluntarily confirms their willingness to
participate in a clinical trial?
Informed consent
Where are a research subject's responsibilities for study participation described?
Informed Consent Form (ICF)
An unconscious subject was enrolled with consent from a Legally Acceptable
Representative (LAR) and later regains consciousness. What should the investigator
do?
Inform the subject about the study and obtain the subject's consent to continue participation.
When is an impartial witness required during informed consent?
When the subject or LAR cannot read (e.g., illiterate subject).
Who must sign the informed consent form?
1. The subject or legally authorized representative
2. The person who conducted the consent discussion
A study has no anticipated direct benefit to participants. What should the ICF state?
That no expected benefit is anticipated.
What increases the risk of coercion during consent?
Obtaining consent in the presence of a figure of authority.
What is assent?
, A child's affirmative agreement to participate in research.
What is the primary purpose of an IRB/IEC?
To safeguard the rights, safety, and well-being of research participants.
What is the minimum number of IRB members?
5
An IRB should include what types of members?
1. At least one non-scientific member
2. At least one member independent of the institution
3. Members with appropriate scientific and ethical expertise
How long must an IRB retain records after completion of a clinical trial?
At least 3 years
Who submits annual progress reports to the IRB?
The investigator
Who has ultimate responsibility for all research conducted at a site?
The Principal Investigator (PI).
What should an investigator determine before agreeing to participate in a trial?
Whether enough eligible patients are available for enrollment.
When a subject wants to withdraw from a study, what should the investigator do first?
Attempt to determine the reason for withdrawal while respecting the subject's decision.
Who is responsible for reporting significant new safety information to participants?
