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ACRP CRC Prep|118 Questions and Answers/100% Verified!!
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ACRP CRC Prep|118 Questions andAnswers/100% Verified!!
ICH E8 - -General Considerations for Clinical Trials
-ICH E6 - -Guideline for Good Clinical Practice
-ICH E9 - -Statistical Principles for Clinical Trials
-ICH E2A - -Clinical Safety Data Management: Definitions and Standards for
Expedited Reporting
-Most typical Phase I Study - -Human Pharmacology
-Phase I - -Estimation of initial safety and tolerability
-Phase I - -Pharmacokinetics and pharmacodynamics
-Most typical Phase II Study - -Therapeutic Exploratory
-Phase II - -Determining dosages and regimens for Phase III trials
-Phase II - -Evaluation of potential study endpoints, therapeutic regimens,
and target populations for further study in Phase III
-Most typical Phase III Study - -Therapeutic Confirmatory
-Phase III - -Designed to confirm the preliminary evidence accumulated in
Phase II that a drug is safe and effective for use in the intended indication
and recipient population. These studies are intended to provide an adequate
basis for marketing approval, and complete the information needed to
support adequate instructions for use of the drug.
-Phase IV - -Various post-approval studies for therapeutic use
-Phase IV - -Studies that were not considered necessary for approval but are
often important for optimizing the drug's use.
-Phase IV - -Commonly conducted studies include additional drug-drug
interaction, dose-response or safety studies and studies designed to support
use under the approved indication.
, -Phase IV - -After initial approval, drug development may continue with
studies of new or modified indications, new dosage regimens, new routes of
administration, or additional patient populations.
-Special Populations - -Some groups in the general population may require
special study because they have unique risk/benefit considerations, such as
pregnant or nursing women, or children.
-Selection of Subjects - -The stage of development and the indication to be
studied should be taken into account in selecting the subject population, as
should prior non-clinical or clinical knowledge. The variability of groups of
patients or healthy volunteers studied in early trials may be limited to a
narrow range by strict selection criteria, but as drug development proceeds,
the populations tested should be broadened to reflect the target population.
-Selection of Subjects - -Trial subjects should not participate concurrently in
more than one clinical trial.
-Selection of Subjects - -Women of childbearing potential should be using
highly effective contraception. For male subjects, potential hazards of drug
exposure in the trial to their sexual partners or resulting progeny should be
considered.
-Selection of Control Group - -Trials should have an adequate control group.
Comparisons may be made with placebo, no treatment, active controls, or of
different doses of the drug under investigation. Historical controls can be
justified in some cases.
-Study Endpoint - -Occurrence of a disease, symptom, or sign that
constitutes one of the target outcomes of the trial, but may also refer to any
such disease or sign that strongly motivates the withdrawal of that individual
from the trial (humane endpoint).
-Primary Endpoint - -Endpoint for which subjects are randomized and for
which the trial is powered.
-Secondary Endpoint - -Endpoints that are analyzed post hoc, for which the
trial may not be powered or randomized.
-Surrogate Endpoint - -Endpoint that is intended to relate to a clinically
important outcome but does not in itself measure a clinical benefit.
-Randomization - -In conducting a controlled trial, randomized allocation is
the preferred means of assuring comparability of test groups and minimizing
the possibility of selection bias. Introduces a deliberate element of chance
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