Good Clinical Practice ICH | 72 Questions and Answers(A+ Solution guide)

What is Good Clinical Practice (GCP)? - An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects What does Good Clinical Practice assure? - Assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. What is the objective Good Clinical Practice Guideline? - To provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Good Clinical Practice Guideline was developed by? - European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO). When should Good Clinical Practice Guideline be followed? - When generating clinical trial data that are intended to be submitted to regulatory authorities. May also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects. What is Adverse drug reaction (ADR)? - All noxious and unintended responses to a medicinal product related to any dose. A causal relationship between a medicinal product and an adverse event. Adverse drug reaction (ADR) of marketed medicinal products: - A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function