CCRC exam ACRP 100% SOLUTION

CCRC exam ACRP 100% SOLUTION Content Validity - ANSWER the extent to which a test samples the behavior that is of interest (such as a driving test that samples driving tasks). Double-Dummy - ANSWER The use of matching placebo to ensure blinding, when all patients receive two formulations (drug and placebo); i.e., active tablet plus placebo liquid compared to placebo tablet and active liquid. Equivalence Trial - ANSWER A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences. Generalisability - ANSWER The extent to which results can be generalised beyond the sample to a wider population or situation Global Assessment Variable - ANSWER A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. Independent Data Monitoring Committee (IDMC) - ANSWER May be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints. (ICH GCP E6 1.25) Intention-to-treat principle - ANSWER The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. It has the consequence that subjects allocated to a treatment group should be followed up, assessed and analysed as members of that group irrespective of their compliance to the planned course of treatment. inter-rater reliability - ANSWER measure of agreement among observers on how they record and classify a particular event Intra-rater reliability - ANSWER degree of agreement among repeated administrations of a diagnostic test performed by a single rater interim analys - ANSWER any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial statistical analysis plan - ANSWER Document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.