Exam (elaborations)
ACRP-CP Exam Questions and Answers (2024 / 2025) (Verified Answers)
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ACRP-CP Exam Questions and Answers (2024 / 2025) (Verified Answers)
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1 /23ACRP-CP Exam1.What is an ADR?: 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 . 2 /232. What is an AE?: 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), symp- tom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
3. What is an SAE?: 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 3 /235.Is a congenital anomaly/birth defect
4.What is an UADR?: 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/sum- mary of product characteristics for an approved product)
5.Who constitutes a vulnerable subject?: Individuals whose willingness to vol- unteer in a clinical trial may be unduly influenced by the expectation of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
Examples are members of a group with a hierarchical structure, such as
medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory per-
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