Common use of Safety Analysis Clause in Contracts

Safety Analysis. The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. No inferential testing will be done for safety analysis.

Safety Analysis. The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and SAEs will be identified. Individual subject listings will be provided, as necessary. No inferential testing will be done for safety analysis.