Analysis Data Sets Clause Samples
The "Analysis Data Sets" clause defines the requirements and standards for the preparation, delivery, and use of data sets that are specifically created for statistical analysis in a project or study. Typically, this clause outlines the format, content, and timing for providing these data sets, ensuring they are suitable for regulatory review or internal analysis. For example, it may specify that data must be anonymized, delivered in a particular file format, and accompanied by documentation describing variables and derivations. The core function of this clause is to ensure that all parties have access to consistent, well-documented data sets that facilitate accurate and efficient analysis, thereby reducing misunderstandings and supporting compliance with regulatory or project requirements.
Analysis Data Sets. 6.2.1 Safety Analysis Set
Analysis Data Sets. The all-implanted analysis set (AAS) will include all eyes with successful test or control article bilateral implantation. The best-case analysis set (BAS) will include all eyes successfully implanted with the test or control article that had at least one postoperative visit, and with no macular degeneration at any time, and no major protocol deviations. Subjects who become pregnant at any time during the study will also be excluded from the BAS. All eyes with attempted test or control article implantation (successful or aborted after contact with the eye) will be considered evaluable for the Safety Set (SS). The primary analysis set for performance analyses will be the AAS for all performance endpoints, except for binocular defocus and contrast sensitivity for which it will be considered supportive. The BAS will be the primary set for binocular defocus and contrast sensitivity. The SS will be used for analysis of safety endpoints.
Analysis Data Sets