Good clinical practice with 100% correct answers 2023/2024

Good clinical practice good clinical practice (GCP) - correct answer A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. GCP Objective - correct answer provide a unified standard for the european union, japan, and US to facilitate the mutual acceptance of clinical data by the regulatory authorities of these jurisdictions Adverse Drug Reaction (ADR) - correct answer all noxious (harmful) and unintended responses to a medicinal product responses to a medicinal product - correct answer causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. Adverse Drug Reaction (ADR) Regarding marketed medicinal products - correct answer normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function Adverse Event (AE) - correct answer 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 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) - correct answer Any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity, or - is a congenital anomaly/birth defect