ACRP-CP Certification Exam 2024/25 EDITION GUARANTEED GRADE A+
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial?
Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC syst...
ACRP-CP Certification Exam 2024/25
EDITION GUARANTEED GRADE A+
What would be the first priority for an investigator when a subject
wishes to withdraw prematurely from the trial?
Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system
must conform to the established requirements for
Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial
data handling is to
maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should
be described in the
ICF
What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP?
Investigators brochure
During a multi site clinical study: whose responsibility is it to
report subject recruitment rate?
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
Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3
trial: and has received IRB approval. The site can begin enrolling
subjects after...
A signed clinical trial agreement between the site and sponsor is in
place.
A site is screening potential subjects for a study looking at mild
cognitive impairment. One of the inclusion criteria is a score of 25
or less on a psychometric test: a research specific tool which
measures cognitive ability. Which of the following individuals can
administer the psychometric test to the potential subjects?
A research assistant who is certified to administer the psychometric
test
,A research study: in which there is no intended clinical benefit to
the subject: is being submitted to the IRB. What benefit information
should be included in the ICF?
Wording indicating that there is no expected benefit should be
included
A CRA notices during an onsite visit that the date on IRB approval
letter for a protocol is prior to the effective date indicated on the
cover page of the protocol and the signatures of the investigator and
sponsor. What should the CRA do FIRST?
Confirm dates of initial receipt of the sponsor protocol and the IRB
submission dates.
In a multi arm: randomized clinical trial: one arm of the protocol
was terminated due to an increased risk of cancer in subjects. Who is
responsible for providing a written report to the IRB?
PI
Which of the following required elements should be included in a
clinical trial protocol?
Subject inclusion and exclusion criteria
Prior to archiving a study: documentation of IP destruction at the
site should be filed in the study files of the
PI and Sponsor
During a monitoring visit: what records would a CRA reference to
verify a subject's compliance to the study visit schedule and
assessments?
Electronic medical record
When considering participation in a study: the investigator should
determine if he...
Sees enough patients who would qualify for the study
New safety information has become available from the Sponsor about
the IP being used in a clinical trial. The investigator must
Submit a revised ICF to the IRB noting the new safety information
Per ICH: an IRB must keep correspondence for at least how long after
the completion of a clinical trial?
3 Years
When would an impartial witness be needed during the consent process
for an illiterate subject?
To observe the consent process
A study which seeks to determine the ideal dose and regimen of a new
IP to treat hypothyroidism is considered to be
Phase II
After completion of a study: the final trial close out monitoring
report prepared by the CRA should be filed in which of the following
stakeholder files?
The sponsors files
, A blood sample collection is required to screen for bloodborne
pathogens before subject could be enrolled in a study. Where will
subjects find information of the procedures and any foreseeable risks
or inconveniences?
ICF
When should a research study involving human subjects be registered
in a publicly accessible database?
Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of
the signed and dated ICF?
The subjects legally acceptable representative
A medical student is approaches by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which
of the following increases risk to the study?
Consenting in the presence of figure of authority
The clinical trial phase that focuses on safety and human
pharmacology in healthy volunteers
Phase I
Who is ultimately responsible for all aspects of the research
conducted at a site?
Principal investigator
An international quality standard that is provided by ICH E6(R2)
describing safety: accuracy of trials and credibility of data
GCP
What event resulted in the Nuremburg Cod of 1949
Nazi Medical Experiments
Prior to archiving a study: documentation of IP destruction at the
site should be filed in the study files of the
PI and Sponsor
In the case of an incapacitated subject: who should receive a copy of
the signed and dated ICF?
The subject's legally acceptable representative
Which of the following required elements should be included in a
clinical trial protocol?
The subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it to
report subject recruitment rate?
The CRA
A study which seeks to determine the ideal dose and regimen of a new
IP to treat hypothyroidism is considered to be
Phase II
What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP?
IB
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