ACRP CCRC Exam Prep Latest Update Questions
with Verified Answers. Reliable!!
A 22y/o male was entered into a clinical study for treatment of schizophrenia The study drug
was administered orally, BID. One week later, the subject visited the investigator complaining of
sever sore throat. The IB lists this as an occurrence reported by 1% of subjects receiving drug.
How should this severe throat be classified? - Correct Answers-- An adverse event
- An adverse drug reaction
A number of attributes are considered of universal importance to source data and the records
that hold those data. These include that data records are? - Correct Answers-- Accurate and
legible
-Contemporaneous and original
- Attributable and consistent
A patient cannot recall the name of the heart condition medication he took a few years ago.
This is important information for deciding whether the patient may be enrolled in a clinical trial
(IC/EC). What's your best course of action? - Correct Answers-You attempt to retrieve the
patients medical history by contacting previous caregivers and you wait for additional
information before enrollment.
A person with LEP? - Correct Answers-Limited ability to read, write, and/or speak english.
A protocol amendment was issued for a trial. Your site received IRB approval for the
amendment and wants to implement the increase in PO dose for your trial subjects as identified
in the amendment trial subjects. As delegated consenting duties you must re-consent trial
subjects before being able to administer the adjusted dose. You decide to only re-consent trial
subjects who are still taking the IP and not from the subjects woh already completed their drug
intake period. Is this allowed according the E6 Guideline for GCP? - Correct Answers-No,
these subjects are still enrolled in the trial and therefore need to be updated on any changes to
the protocol.
A report prepared by marketing-authorization holder describing the worldwide safety
experience with medicine at defined time after authorization is called? - Correct Answers-
Periodic Safety Update Report (PSUR)
A site struggles with the conduct of a phase III trial due to lack of site staff to be able to conduct
all visits and collect required data as identified in the protocol. Upon completion, the
,investigator tells the CRA and site staff during a follow-up meeting that she no longer wants to
conduct trials because of the resource challenges they faced. What would you recommend the
investigator do? - Correct Answers-Evaluate available resources (staff, time, patient
population, financial) and conduct trials in phase for which the site has resources.
A study protocol provides? - Correct Answers-A plan for a scientific experiment or for
medical treatment.
A trial subject in a cardiology trial is admitted to hospital with heart attack. The investigator
considers this event possibly related to the study drug even though this is not listed in the IB as
a potential adverse reaction. What would the investigator report this event to the sponsor as? -
Correct Answers-An unexpected, serious adverse event
A trial subject informs you she no longer wants to participant in the trial. What should your
course of action be? - Correct Answers-You ask if the patient wishes to share the reason why
she wants to leave the trial. If not, you exclude the subject from the trial immediately.
A trial subject suffers from severe repeat headaches. Should this adverse event be reported to
the IRB? - Correct Answers-No
Acceptable method used to assess subject comprehension of consent form and study? -
Correct Answers-Teach-back method
According the MHRA, an inspection finding is considered critical where evidence exists that
signifiant and unjustified departure from applicable legislative requirements has occurred with
evidence that: - Correct Answers-- Safety/well-being of subject jeopardized
- Clinical trial data are unreliable
- Systematic quality assurance failure
According to Declaration of Helsinki, where a proven intervention does NOT exist, the
physician...? - Correct Answers-May consider an unproven intervention.
According to ICH E9, IDMCs should provide what? - Correct Answers-- Intervals assess the
safety of clinical trial
- Recommend to sponsor whether to continue, modify, or stop trial
Activity present in research (scientific) is? - Correct Answers-Exploratory data collection,
analysis, and hypothesis testing.
Adaptive study design is defined as? - Correct Answers-Clinical trials capable of changes in
design/feature in response to accumulated data.
, Adhering to the principles represented in ALCOA-C support? - Correct Answers-Good
documentation practice.
As a foundation for quality control the individuals that implement and follow the systems much
have which of the following characteristics? - Correct Answers-- Solid understanding of the
processes in place
- Rationale behind why each system is required
- Rationale behind why each SOP is required
As clinical researchers we can be culturally competent by? - Correct Answers-Understanding
and acknowledging the difference between various cultures.
At what point during a clinical trial is a 1572 created and signed? - Correct Answers-Study
start-up
At what time period during the trial is a risk management plan benefical? - Correct Answers-
At all stages of the trial.
Capturing source data electronically and transmitting it to the electronic case report form
should? - Correct Answers-- Eliminate unnecessary duplication of data and reduce the
possibility for transcription errors
- Eliminate transcription of source data prior to entry into an electronic CRF
- Promote real time access for data review and facilitate remote monitoring of data
Clinical trials assessing a medicinal products safety may fall which phases? - Correct
Answers-Phase I, II, III, IV
Common inspection management strategies include? - Correct Answers-- Scope of
inspection
- Understand inspection timeframes
-Copy of personnel records
Comparative effectivness study design defined as? - Correct Answers-Research intended to
inform healthcare by assessing existing treatments.
Concept that refers to sensitivity of overall conclusions to various limitations of data,
assumptions, analytic approaches and data analysis. - Correct Answers-Robustness
Consideration not found in protocol is? - Correct Answers-Funding
with Verified Answers. Reliable!!
A 22y/o male was entered into a clinical study for treatment of schizophrenia The study drug
was administered orally, BID. One week later, the subject visited the investigator complaining of
sever sore throat. The IB lists this as an occurrence reported by 1% of subjects receiving drug.
How should this severe throat be classified? - Correct Answers-- An adverse event
- An adverse drug reaction
A number of attributes are considered of universal importance to source data and the records
that hold those data. These include that data records are? - Correct Answers-- Accurate and
legible
-Contemporaneous and original
- Attributable and consistent
A patient cannot recall the name of the heart condition medication he took a few years ago.
This is important information for deciding whether the patient may be enrolled in a clinical trial
(IC/EC). What's your best course of action? - Correct Answers-You attempt to retrieve the
patients medical history by contacting previous caregivers and you wait for additional
information before enrollment.
A person with LEP? - Correct Answers-Limited ability to read, write, and/or speak english.
A protocol amendment was issued for a trial. Your site received IRB approval for the
amendment and wants to implement the increase in PO dose for your trial subjects as identified
in the amendment trial subjects. As delegated consenting duties you must re-consent trial
subjects before being able to administer the adjusted dose. You decide to only re-consent trial
subjects who are still taking the IP and not from the subjects woh already completed their drug
intake period. Is this allowed according the E6 Guideline for GCP? - Correct Answers-No,
these subjects are still enrolled in the trial and therefore need to be updated on any changes to
the protocol.
A report prepared by marketing-authorization holder describing the worldwide safety
experience with medicine at defined time after authorization is called? - Correct Answers-
Periodic Safety Update Report (PSUR)
A site struggles with the conduct of a phase III trial due to lack of site staff to be able to conduct
all visits and collect required data as identified in the protocol. Upon completion, the
,investigator tells the CRA and site staff during a follow-up meeting that she no longer wants to
conduct trials because of the resource challenges they faced. What would you recommend the
investigator do? - Correct Answers-Evaluate available resources (staff, time, patient
population, financial) and conduct trials in phase for which the site has resources.
A study protocol provides? - Correct Answers-A plan for a scientific experiment or for
medical treatment.
A trial subject in a cardiology trial is admitted to hospital with heart attack. The investigator
considers this event possibly related to the study drug even though this is not listed in the IB as
a potential adverse reaction. What would the investigator report this event to the sponsor as? -
Correct Answers-An unexpected, serious adverse event
A trial subject informs you she no longer wants to participant in the trial. What should your
course of action be? - Correct Answers-You ask if the patient wishes to share the reason why
she wants to leave the trial. If not, you exclude the subject from the trial immediately.
A trial subject suffers from severe repeat headaches. Should this adverse event be reported to
the IRB? - Correct Answers-No
Acceptable method used to assess subject comprehension of consent form and study? -
Correct Answers-Teach-back method
According the MHRA, an inspection finding is considered critical where evidence exists that
signifiant and unjustified departure from applicable legislative requirements has occurred with
evidence that: - Correct Answers-- Safety/well-being of subject jeopardized
- Clinical trial data are unreliable
- Systematic quality assurance failure
According to Declaration of Helsinki, where a proven intervention does NOT exist, the
physician...? - Correct Answers-May consider an unproven intervention.
According to ICH E9, IDMCs should provide what? - Correct Answers-- Intervals assess the
safety of clinical trial
- Recommend to sponsor whether to continue, modify, or stop trial
Activity present in research (scientific) is? - Correct Answers-Exploratory data collection,
analysis, and hypothesis testing.
Adaptive study design is defined as? - Correct Answers-Clinical trials capable of changes in
design/feature in response to accumulated data.
, Adhering to the principles represented in ALCOA-C support? - Correct Answers-Good
documentation practice.
As a foundation for quality control the individuals that implement and follow the systems much
have which of the following characteristics? - Correct Answers-- Solid understanding of the
processes in place
- Rationale behind why each system is required
- Rationale behind why each SOP is required
As clinical researchers we can be culturally competent by? - Correct Answers-Understanding
and acknowledging the difference between various cultures.
At what point during a clinical trial is a 1572 created and signed? - Correct Answers-Study
start-up
At what time period during the trial is a risk management plan benefical? - Correct Answers-
At all stages of the trial.
Capturing source data electronically and transmitting it to the electronic case report form
should? - Correct Answers-- Eliminate unnecessary duplication of data and reduce the
possibility for transcription errors
- Eliminate transcription of source data prior to entry into an electronic CRF
- Promote real time access for data review and facilitate remote monitoring of data
Clinical trials assessing a medicinal products safety may fall which phases? - Correct
Answers-Phase I, II, III, IV
Common inspection management strategies include? - Correct Answers-- Scope of
inspection
- Understand inspection timeframes
-Copy of personnel records
Comparative effectivness study design defined as? - Correct Answers-Research intended to
inform healthcare by assessing existing treatments.
Concept that refers to sensitivity of overall conclusions to various limitations of data,
assumptions, analytic approaches and data analysis. - Correct Answers-Robustness
Consideration not found in protocol is? - Correct Answers-Funding
