E6 (R2) Good Clinical Practice fully solved 2023/2024

E6 (R2) Good Clinical PracticeAdverse Drug Reaction (ADR) - correct answer all noxious and unintended response to a medicinal product where a causal relationship is at least a reasonable possibility. Adverse Event (AE) - correct answer 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 Audit Certificate - correct answer Audit has taken place Audit Report - correct answer Results of the audit Audit Trail - correct answer Reconstruction of the course of events Single Blind - correct answer Subject is unaware of their treatment assignment Double Blind - correct answer Subject, investigator, monitor and in some cases the data analyst being unaware of treatment assignment. Case Report Form (CRF) - correct answer Printed or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. Certified Copy - correct answer Copy of the original record that has been verified or has been generated through a validated process to produce an exact copy Clinical Trial - correct answer Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product and/or to study absorption, distribution, metabolism and excretion of an investigational product with the object of ascertaining its safety and/or efficacy.