What is an ADR? - ANSWER Adverse drug reaction (ADR)
1.Pre-approval clinical experience with a new medicinal product or its new usages: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal...
ACRP-CP Exam QUESTIONS &
SOLUTIONS(RATED A)
What is an ADR? - ANSWER Adverse drug reaction (ADR)
1.Pre-approval clinical experience with a new medicinal product or its new usages: all noxious and
unintended responses to a medicinal product related to any dose should be considered adverse drug
reactions. The phrase responses to a medicinal product means that a causal relationship between a
medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot
be ruled out.
2. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and
which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function.
What is an AE? - ANSWER Adverse event (AE)
1. Any untoward medical occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated with the use of a medicinal
(investigational) product, whether or not related to the medicinal (investigational) product.
What is an SAE? - ANSWER Serious adverse event (SAE)
1. Results in death
2. Is life-threatening
3. Requires inpatient hospitalization or prolongation of existing hospitalization
4. Results in persistent or significant disability/incapacity
5. Is a congenital anomaly/birth defect
, What is an UADR? - ANSWER Unexpected adverse drug reaction (UADR)
1. An adverse reaction, the nature or severity of which is not consistent with the applicable product
information (e.g., IB for an unapproved IP or package insert/summary of product characteristics for an
approved product)
How frequently should the IRB/IEC conduct a CR of each ongoing trial? - ANSWER The IRB/IEC should
conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human
subjects, but at least once per year.
What is the minimum number of members for an IRB/IEC? And what specific people need to be
involved? - ANSWER (a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.
What four things should the investigator promptly report to the IRB/IEC? - ANSWER (a) Deviations from,
or changes of, the protocol to eliminate immediate hazards to the trial subjects.
(b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial.
(c) All adverse drug reactions (ADRs) that are both serious and unexpected.
(d) New information that may affect adversely the safety of the subjects or the conduct of the trial.
For how long should the IRB/IEC retain all relevant records? - ANSWER The IRB/IEC should retain all
relevant records for a period of at least 3-years after completion of the trial and make them available
upon request from the regulatory authority(ies).
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