ACRP CP FINAL EXAM NEWEST 2024-2025
ACTUAL EXAM COMPLETE 150
QUESTIONS AND CORRECT DETAILED
ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+
According to ICH GCP how frequently should staff be trained in
GCP? - CORRECT ANSWER-There is no specific requirement
Investigator, should fully inform the subject if the subject is
unable to provide informed consent, the ___________, of all
pertinent aspects of the trial including the written information
and the approval/ favourable opinion by the IRB/IEC: -
CORRECT ANSWER-legally responsibly representative
Responsibility for investigational product(s) accountability at
the trial site(s) rests with: - CORRECT ANSWER-the
investigator/ institution
According to ICH GCP which documents, document the
existence of the subject and substantiate integrity of trial data
collected? - CORRECT ANSWER-Source documents
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Who is responsible for all trial-related medical (or dental)
decisions? - CORRECT ANSWER-a qualified physician or
dentist
According to ICH GCP which of the following statements are
true about record retention? 1. The sponsor should inform the
investigator in writing of the need for record retention 2. The
sponsor should notify the investigator in writing when the trial
related records are no longer needed 3. It is the responsibility of
the investigator to notify the IRB/IEC when the trial related
records are no longer needed - CORRECT ANSWER-only 1
and 2
According to ICH GCP Who is responsible for selecting
Investigator/Institution: - CORRECT ANSWER-Sponsor
According to ICH GCP if the trial is prematurely terminated or
suspended for any reason, the investigator/institution should do
which of the following as well as notifying IRB/IEC and local
regulatory authorities:1. Return all IMP to the sponsor
immediately2. Contact all subjects to ensure immediate return of
all IMP3. Promptly inform the trial subject4. Should assure
appropriate therapy and treatment follow-up for the subjects -
CORRECT ANSWER-3 & 4 only
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According to ICH GCP, The financial aspects of the trial should
be documented in an agreement between: - CORRECT
ANSWER-Sponsor and investigator
The ICH GCP guideline should be read in conjunction with
other ICH guidelines relevant to the ______________ of clinical
trials - CORRECT ANSWER-Conduct
According to ICH GCP Non-therapeutic trials may be conducted
in subjects with consent of a legally acceptable representative
provided the following conditions are fulfilled: 1) The negative
impact on the subject's well-being is minimized and low 2) The
trial is not prohibited by law 3) The foreseeable risks to the
subjects are low 4) The objectives of the trial can not be met by
means of a trial in subjects who can give informed consent
personally - CORRECT ANSWER-All of them
According to ICH GCP All serious adverse events (SAEs)
should be reported immediately to the: - CORRECT ANSWER-
Sponsor
According to ICH GCP who is responsible for training the
investigator in GCP? - CORRECT ANSWER-There is no
specification
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