Ccrc Exam Acrp - Questions & Answers (Rated 96%) Best Update 2024

phase 4 study {Ans: continual evaluation of a drug after it has been released for marketing}Suspected Unexpected Serious Adverse Reaction (SUSAR) {Ans: an adverse event that occurs in a clinical trial subject, which is assessed by the sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. Reports of these reactions are subject to expedited submission to health authorities.}Good Clinical Practice (GCP) {Ans: 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.}secondary variable {Ans: not part of the hypothesis under investigation but have potential for confounding}Content Validity {Ans: the extent to which a test samples the behavior that is of interest (such as a driving test that samples driving tasks).}factorial design {Ans: a study in which there are two or more independent variables, or factors}Intention-to-treat principle {Ans: The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of