A C R P CP FINAL EXAM 2024/2025 WITH QUESTIONS AND
VERIFIED CORRECT ANSWERS/ ALREADY GRADED A++
How is the number of study participants needed usually determined? -
ANSWER By the primary objective of the study.
When can IRB waive informed consent? -ANSWER IRB has the ability to
waive the informed consent requirement if the research is no more than
minimal risk and involves no procedures for which consent is required
outside of the research context and in emergency research
What are the four types of monitoring visits? -ANSWER Qualification,
Initiation, Routine, Close-Out
Whom should the sponsor notify of findings that affect the safety of the
subjects? -ANSWER All participating investigators and the regulatory
authority
EDC System must conform to what established requirements? -ANSWER
validation, accuracy, reliability and completeness
What is the Sponsor's responsibility pertaining to electronic trial data
handling? -ANSWER Maintain an audit trial, data trial, and edit trial
During a multisite clinical study, whose responsibility is it to report subject
recruitment rate? -ANSWER CRA
Per ICH, an IRB must keep correspondence for at least how long after the
completion of a clinical trial? -ANSWER 3 years
When is the PI allowed to deviate from the protocol without prior approval
from the IRB/IEC? -ANSWER when there is an immediate hazard to the
subject
What are the 3 elements of the consent process? -ANSWER Information,
comprehension, and voluntariness
,What is an example of how beneficence can be applied to a study
employing human subjects? -ANSWER Maximizing benefits & minimizing
risks
Which is an optional section in the IB? -ANSWER The Signature Page
Before recruitment of the first subject begins, a study MUST...? -ANSWER
Be registered in a publicly accessible database.
What are the 3 recommendations that an IRB should include? -ANSWER 1.
at least 5 members
2. one member whose primary area of interest is not a scientific area
3. one member who is independent of the institution/trial site
Within how many days of an SAE must a Sponsor report the incident to
authorities? -ANSWER 15 calendar days
Who is the Declaration of Helsinki primarily addressed to? -ANSWER
Physicians
What are the 4 main ICH guidelines? -ANSWER Safety, Efficacy, Quality &
Multidisciplinary
What is the role of ICH? -ANSWER Oversees the implementation of Good
Clinical Practice (GCP) guidelines, ensuring that the planning, execution,
and documentation of clinical trials are conducted ethically and with
scientific integrity at every phase of the research process.
Who must assess whether to continue, modify or stop a study when the
risks are found to outweigh the potential benefits? -ANSWER The
Physician
What document should contain a statement of the ethical considerations
involved and should indicate how the principles in the Declaration of
Helsinki have been addressed? -ANSWER The protocol
The Belmont report's principle of respect for persons incorporates what 2
ethical convictions? -ANSWER 1. Individuals should be treated as
autonomous agents
2. Individuals with diminished autonomy are entitled to protection.
,Fatal or Life-Threatening unexpected ADRs must be reported to regulatory
agencies no later than... -ANSWER 7 calendar days from first knowledge
by sponsor that case qualifies
Serious ADRs that are not fatal or life-threatening must be reported to
regulatory agencies no later than... -ANSWER 15 calendar days from first
knowledge by sponsor that case qualifies
Who is responsible for providing the up-to-date IB to the responsible
IRBs/IECs? -ANSWER The Investigator
How long should essential documents be retained? -ANSWER 2 years
after the last approval of a marketing application (this includes no pending
or contemplated marketing applications.)
OR at least 2-years have elapsed since the formal discontinuation of
clinical development of the investigational product.
These documents should be retained for a longer period if required by
regulatory requirements or by an agreement with the sponsor.
Which of the following is an essential document that must be included in
the Trial Master File (TMF)?
A) Investigator's Brochure
B) Patient's personal health records
C) Researcher's tax returns
D) Sponsor's business plan -ANSWER A) Investigator's Brochure
Which 4 factors are useful in measuring the effects of a medicinal product
on children? -ANSWER Skeletal growth, weight gain, school attendance,
and school performance.
In which pediatric population are most pathways of drug clearance mature?
-ANSWER 'Children' ages 2-11 years
What are 3 key practical factors to consider in pediatric clinical studies? -
ANSWER Feasibility, outcome assessments, and long-term aspects
including safety.
, What application permits to do research on humans for the first time? Has
background information and rationale? Required to be updated annually. -
ANSWER 1571
What is the investigator statement? This document is completed nationally
and internationally by sponsor intending to have marketing approval for IP.
-ANSWER 1572
What is the importance of Subject stipends? -ANSWER Must be approved
by IRB to make sure the timing and amount is not coercive, nor influences
the subject
What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial? -ANSWER Try to obtain the subject's
reason for withdrawal.
A CRO recently switched from paper CRF to an EDC system. The EDC
system must conform to the established requirements for -ANSWER
validation, accuracy, reliability, completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling
is to -ANSWER maintain an audit trial, data trial and edit trial
A research subject's responsibilities for study participation should be
described in what document? -ANSWER ICF
What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP? -ANSWER
Investigators brochure (IB)
During a multi site clinical study: whose responsibility is it to report subject
recruitment rate? -ANSWER The CRA
An unconscious adult subject was enrolled in a study after obtaining
consent from an LAR and protocol therapy was initiated. The subject
showed significant improvement in his clinical condition and regained
consciousness. The investigator should inform the subject about the study
and ... -ANSWER obtain consent from the subject for the study
VERIFIED CORRECT ANSWERS/ ALREADY GRADED A++
How is the number of study participants needed usually determined? -
ANSWER By the primary objective of the study.
When can IRB waive informed consent? -ANSWER IRB has the ability to
waive the informed consent requirement if the research is no more than
minimal risk and involves no procedures for which consent is required
outside of the research context and in emergency research
What are the four types of monitoring visits? -ANSWER Qualification,
Initiation, Routine, Close-Out
Whom should the sponsor notify of findings that affect the safety of the
subjects? -ANSWER All participating investigators and the regulatory
authority
EDC System must conform to what established requirements? -ANSWER
validation, accuracy, reliability and completeness
What is the Sponsor's responsibility pertaining to electronic trial data
handling? -ANSWER Maintain an audit trial, data trial, and edit trial
During a multisite clinical study, whose responsibility is it to report subject
recruitment rate? -ANSWER CRA
Per ICH, an IRB must keep correspondence for at least how long after the
completion of a clinical trial? -ANSWER 3 years
When is the PI allowed to deviate from the protocol without prior approval
from the IRB/IEC? -ANSWER when there is an immediate hazard to the
subject
What are the 3 elements of the consent process? -ANSWER Information,
comprehension, and voluntariness
,What is an example of how beneficence can be applied to a study
employing human subjects? -ANSWER Maximizing benefits & minimizing
risks
Which is an optional section in the IB? -ANSWER The Signature Page
Before recruitment of the first subject begins, a study MUST...? -ANSWER
Be registered in a publicly accessible database.
What are the 3 recommendations that an IRB should include? -ANSWER 1.
at least 5 members
2. one member whose primary area of interest is not a scientific area
3. one member who is independent of the institution/trial site
Within how many days of an SAE must a Sponsor report the incident to
authorities? -ANSWER 15 calendar days
Who is the Declaration of Helsinki primarily addressed to? -ANSWER
Physicians
What are the 4 main ICH guidelines? -ANSWER Safety, Efficacy, Quality &
Multidisciplinary
What is the role of ICH? -ANSWER Oversees the implementation of Good
Clinical Practice (GCP) guidelines, ensuring that the planning, execution,
and documentation of clinical trials are conducted ethically and with
scientific integrity at every phase of the research process.
Who must assess whether to continue, modify or stop a study when the
risks are found to outweigh the potential benefits? -ANSWER The
Physician
What document should contain a statement of the ethical considerations
involved and should indicate how the principles in the Declaration of
Helsinki have been addressed? -ANSWER The protocol
The Belmont report's principle of respect for persons incorporates what 2
ethical convictions? -ANSWER 1. Individuals should be treated as
autonomous agents
2. Individuals with diminished autonomy are entitled to protection.
,Fatal or Life-Threatening unexpected ADRs must be reported to regulatory
agencies no later than... -ANSWER 7 calendar days from first knowledge
by sponsor that case qualifies
Serious ADRs that are not fatal or life-threatening must be reported to
regulatory agencies no later than... -ANSWER 15 calendar days from first
knowledge by sponsor that case qualifies
Who is responsible for providing the up-to-date IB to the responsible
IRBs/IECs? -ANSWER The Investigator
How long should essential documents be retained? -ANSWER 2 years
after the last approval of a marketing application (this includes no pending
or contemplated marketing applications.)
OR at least 2-years have elapsed since the formal discontinuation of
clinical development of the investigational product.
These documents should be retained for a longer period if required by
regulatory requirements or by an agreement with the sponsor.
Which of the following is an essential document that must be included in
the Trial Master File (TMF)?
A) Investigator's Brochure
B) Patient's personal health records
C) Researcher's tax returns
D) Sponsor's business plan -ANSWER A) Investigator's Brochure
Which 4 factors are useful in measuring the effects of a medicinal product
on children? -ANSWER Skeletal growth, weight gain, school attendance,
and school performance.
In which pediatric population are most pathways of drug clearance mature?
-ANSWER 'Children' ages 2-11 years
What are 3 key practical factors to consider in pediatric clinical studies? -
ANSWER Feasibility, outcome assessments, and long-term aspects
including safety.
, What application permits to do research on humans for the first time? Has
background information and rationale? Required to be updated annually. -
ANSWER 1571
What is the investigator statement? This document is completed nationally
and internationally by sponsor intending to have marketing approval for IP.
-ANSWER 1572
What is the importance of Subject stipends? -ANSWER Must be approved
by IRB to make sure the timing and amount is not coercive, nor influences
the subject
What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial? -ANSWER Try to obtain the subject's
reason for withdrawal.
A CRO recently switched from paper CRF to an EDC system. The EDC
system must conform to the established requirements for -ANSWER
validation, accuracy, reliability, completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling
is to -ANSWER maintain an audit trial, data trial and edit trial
A research subject's responsibilities for study participation should be
described in what document? -ANSWER ICF
What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP? -ANSWER
Investigators brochure (IB)
During a multi site clinical study: whose responsibility is it to report subject
recruitment rate? -ANSWER The CRA
An unconscious adult subject was enrolled in a study after obtaining
consent from an LAR and protocol therapy was initiated. The subject
showed significant improvement in his clinical condition and regained
consciousness. The investigator should inform the subject about the study
and ... -ANSWER obtain consent from the subject for the study
