ICH E2A Definitions and Standards for Expedited Reporting exam 2024 with correct answers

Adverse Event (or Adverse Experience) correct answersAny untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) correct answersAll noxious and unintended responses to a medicinal product related to any dose. Unexpected Adverse Drug Reaction correct answersAn adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). Serious Adverse Event correct answersA ______________ is any untoward medical occurrence that at any dose: * results in death, * is life-threatening, * requires inpatient hospitalisation or prolongation of existing hospitalisation, * results in persistent or significant disability/incapacity, or * is a congenital anomaly/birth defect. Single Cases of Serious, Unexpected ADRs correct answersWhat kind of reactions are subject to expedited reporting? 7 correct answersRegulatory agencies should be notified (e.g., by telephone, facsimile transmission, or in writing) as soon as possible but no later than ___ calendar days after first knowledge by the sponsor of a fatal or life-threatening unexpected ADRs.