ACRP Study test in depth Examination and 100% correctly verified Solutions Latest version 2024/2025
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Course
ACRP-CP
Institution
ACRP-CP
ACRP Study test in depth Examination and 100% correctly verified Solutions Latest version 2024/2025
According to ICH guidelines, the source document should contain which of the following information regarding informed consent? - correct answer Evidence that the consent form was signed prior to...
ACRP Study test in depth Examination and
100% correctly verified Solutions Latest
version 2024/2025
According to ICH guidelines, the source document should
contain which of the following information regarding informed
consent? - correct answer Evidence that the consent form was
signed prior to trial related procedures
A subject has signed the informed consent form for a
hypertenstion trial. All screening procedures and the physical
examination have been completed. The CRC is ready to dispense
the single-blind placebo to the subject who asks "Is that the
sugar pill I read about in that form I signed?" Which of the
following should the CRC tell the subject? - correct answer "It
might be placebo, but we will be checking your blood pressure
every week"
At the month 3 visit of a Phase III double-blind trial, the subject
informs the CRC that he was seen in the emergency department
for an anaphylactic reaction. The subject states "The doctor told
me i was very lucky. I might have died". Having received this
information, the MOST appropriate sequence of action is to
inform the: - correct answer PI, sponsor and IRB
Which of the following scenarios are considered saes?
1. Infection following surgery prolonging hospital stay.
2. Pregnancy resulting in normal delivery of twins
3. Boating accident with overnight hospital stay
, 4. Use of illicit drug during trial - correct answer Infection
following surgery, prolonging hospitalization
Boating accident with overnight hospitalization
A subject is admitted to the hospital for chest pain and suspected
myocardial infarction. This subject gave informed consent for a
trial of a new antihistamine 1 week before the onset of any chest
pain. The subject took the first dose of the test article 2 days ago.
The PI determines the event is probably related to the IP. Which
of the following is the BEST course of action for the CRC to take -
correct answer Notify the sponsor that the PI believes the
event is related to the IP
Which of the following would require prior consent when
screening a subject? - correct answer Washout from
medication
The protocol and protocol summary have been submitted to a
central IRB/IEC for review/approval by the CRO prior to the
investigator's meeting. Following the meeting, the entry criteria
are altered to facilitate the recruitment and retention of eligible
subjects. Prior to trial start up, the regulatory binder must
include:
1. An IRB letter of approval for the amended protocol
2. An IRB site evaluation form
3. The amended protocol
4. The investigator's brochure - correct answer 1,3,4
IRB letter of approval for amendment
Amended protocol
IB
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