Good Clinical Practice ICH exam with answers

Good Clinical Practice ICH exam /| /| /| /| /|




with answers /|




What is Good Clinical Practice (GCP)? - CORRECT ANSWERS ✔✔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? - CORRECT ANSWERS
/| /| /| /| /| /| /| /| /|



✔✔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? - CORRECT
/| /| /| /| /| /| /| /| /| /|



ANSWERS ✔✔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? - CORRECT
/| /| /| /| /| /| /| /| /|



ANSWERS ✔✔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? -
/| /| /| /| /| /| /| /| /|



CORRECT ANSWERS ✔✔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)? - CORRECT ANSWERS ✔✔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: -
/| /| /| /| /| /| /| /| /|



CORRECT ANSWERS ✔✔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
/| /|




Applicable regulatory requirement(s): - CORRECT ANSWERS /| /| /| /| /| /|



✔✔Any law(s) and regulation(s) addressing the conduct of clinical
/| /| /| /| /| /| /| /| /|



trials of investigational products.
/| /| /|




Approval (in relation to Institutional Review Boards) - CORRECT
/| /| /| /| /| /| /| /| /|



ANSWERS ✔✔The affirmative decision of the IRB that the clinical /| /| /| /| /| /| /| /| /| /|



trial has been reviewed and may be conducted at the institution sit
/| /| /| /| /| /| /| /| /| /| /|




Audit - CORRECT ANSWERS ✔✔A systematic and independent
/| /| /| /| /| /| /| /|



examination of trial related activities and documents /| /| /| /| /| /|