ACRP-CP CERTIFICATION EXAM NEWEST
ACTUAL EXAM WITH COMPLETE
QUESTIONS AND DETAILED ANSWERS
GRADED A | BRAND NEW!!!
Who is most responsible for the appropriate monitoring of
clinical trials? - ✔✔✔ Correct Answer > Sponsor
You are asked to monitor a study for another Coordinator. In
looking for the changes made in the source document you want
to see which of the following - ✔✔✔ Correct Answer > 1.
Unobscured original entries
2. Traceable source documents
3. An Audit trail
A Clinical Research Coordinator (CRC) adjusted the dose of the
Investigation Product (IP) for a subject as the subject was
suffering from Adverse Events (AEs) like headaches and
vomiting. When is a CRC allowed to do this task? - ✔✔✔
Correct Answer > Only when the CRC is a qualified physician
and has been delegated this responsibility by the PI
,You are in the role of Study Manager for the Sponsor. One of
your monitors reports significant noncompliance at a Site. The
first course of action you implement is that a __________ be
conducted. - ✔✔✔ Correct Answer > Root Cause Analysis
A subject: who has been 100% compliant thus far has forgotten
to bring her medication back to the clinic for her regular visit.
She reports that she has not missed any doses and has been
fully compliant with the protocol. What is the most appropriate
action for the investigator/clinical research coordinator to
take? - ✔✔✔ Correct Answer > Document that the subject has
forgotten to return her medication in the source document and
ask her to bring the medication back to the clinic as soon as
possible or during her next visit
If sponsor's attempts to secure compliance have failed: and the
monitoring/auditing identifies serious and/or persistent
noncompliance on the part of an investigator/institution: the
sponsor should - ✔✔✔ Correct Answer > 1. Promptly notify the
regulatory authority(ies)
2. Terminate the investigator's/institution's participation in the
trial
,Essential documents should be retained at least ______ after
the last approval of a marketing application: or formal
discontinuation of clinical development of the investigational
product. - ✔✔✔ Correct Answer > 2 years
What is the purpose of the IRB/IEC? - ✔✔✔ Correct Answer >
Safeguard the rights: safety: and well-being of all trial subjects
Which of the following should the investigator do FIRST if a
Serious Adverse Event (SAE) occurs? - ✔✔✔ Correct Answer >
Inform the Sponsor per protocol and regulatory requirements
According to ICH E6 Who must sign the Informed Consent Form
(ICF)? - ✔✔✔ Correct Answer > 1. The person who conducted
the informed consent interview
2. The subject or the subject's legal representative
A non-English speaking subject has responded to a recruitment
ad to participate in a trial for treatment of her diabetes. She
arrives at the site with her daughter who is fluent in English.
The informed consent forms are only available in English. What
actions are compliant with GCP? - ✔✔✔ Correct Answer > Call
the sponsor to request a translation of the informed consent
, Per ICH GCP E6: the purpose/elements of trial monitoring differ
from trial auditing. Which apply to trial auditing ONLY? - ✔✔✔
Correct Answer > 1. The sponsor should appoint individuals:
who are independent of the clinical trials/systems
2. Regulatory authority(ies) should not routinely request this
type of reports*
*(they may seek access to reports on a case by case basis when
evidence of serious GCP non-compliance exists: or in the course
of legal proceedings)
As per ICH E6 GCP: which groups of potential subjects could be
defined as "vulnerable subjects?" - ✔✔✔ Correct Answer > 1.
Members of the armed forces
2. Junior members of the medical profession
3. Employees of the pharmaceutical industry
Which phase determines therapeutic benefit: usually in wider
populations? - ✔✔✔ Correct Answer > Phase 3
What phase of a clinical trial involves a heavy emphasis on
safety and tolerability: Pharmacokinetics: Pharmacodynamics
ACTUAL EXAM WITH COMPLETE
QUESTIONS AND DETAILED ANSWERS
GRADED A | BRAND NEW!!!
Who is most responsible for the appropriate monitoring of
clinical trials? - ✔✔✔ Correct Answer > Sponsor
You are asked to monitor a study for another Coordinator. In
looking for the changes made in the source document you want
to see which of the following - ✔✔✔ Correct Answer > 1.
Unobscured original entries
2. Traceable source documents
3. An Audit trail
A Clinical Research Coordinator (CRC) adjusted the dose of the
Investigation Product (IP) for a subject as the subject was
suffering from Adverse Events (AEs) like headaches and
vomiting. When is a CRC allowed to do this task? - ✔✔✔
Correct Answer > Only when the CRC is a qualified physician
and has been delegated this responsibility by the PI
,You are in the role of Study Manager for the Sponsor. One of
your monitors reports significant noncompliance at a Site. The
first course of action you implement is that a __________ be
conducted. - ✔✔✔ Correct Answer > Root Cause Analysis
A subject: who has been 100% compliant thus far has forgotten
to bring her medication back to the clinic for her regular visit.
She reports that she has not missed any doses and has been
fully compliant with the protocol. What is the most appropriate
action for the investigator/clinical research coordinator to
take? - ✔✔✔ Correct Answer > Document that the subject has
forgotten to return her medication in the source document and
ask her to bring the medication back to the clinic as soon as
possible or during her next visit
If sponsor's attempts to secure compliance have failed: and the
monitoring/auditing identifies serious and/or persistent
noncompliance on the part of an investigator/institution: the
sponsor should - ✔✔✔ Correct Answer > 1. Promptly notify the
regulatory authority(ies)
2. Terminate the investigator's/institution's participation in the
trial
,Essential documents should be retained at least ______ after
the last approval of a marketing application: or formal
discontinuation of clinical development of the investigational
product. - ✔✔✔ Correct Answer > 2 years
What is the purpose of the IRB/IEC? - ✔✔✔ Correct Answer >
Safeguard the rights: safety: and well-being of all trial subjects
Which of the following should the investigator do FIRST if a
Serious Adverse Event (SAE) occurs? - ✔✔✔ Correct Answer >
Inform the Sponsor per protocol and regulatory requirements
According to ICH E6 Who must sign the Informed Consent Form
(ICF)? - ✔✔✔ Correct Answer > 1. The person who conducted
the informed consent interview
2. The subject or the subject's legal representative
A non-English speaking subject has responded to a recruitment
ad to participate in a trial for treatment of her diabetes. She
arrives at the site with her daughter who is fluent in English.
The informed consent forms are only available in English. What
actions are compliant with GCP? - ✔✔✔ Correct Answer > Call
the sponsor to request a translation of the informed consent
, Per ICH GCP E6: the purpose/elements of trial monitoring differ
from trial auditing. Which apply to trial auditing ONLY? - ✔✔✔
Correct Answer > 1. The sponsor should appoint individuals:
who are independent of the clinical trials/systems
2. Regulatory authority(ies) should not routinely request this
type of reports*
*(they may seek access to reports on a case by case basis when
evidence of serious GCP non-compliance exists: or in the course
of legal proceedings)
As per ICH E6 GCP: which groups of potential subjects could be
defined as "vulnerable subjects?" - ✔✔✔ Correct Answer > 1.
Members of the armed forces
2. Junior members of the medical profession
3. Employees of the pharmaceutical industry
Which phase determines therapeutic benefit: usually in wider
populations? - ✔✔✔ Correct Answer > Phase 3
What phase of a clinical trial involves a heavy emphasis on
safety and tolerability: Pharmacokinetics: Pharmacodynamics
