Safety Objectives. 56.1 The Parties recognise the potentially hazardous nature of the construction industry. To this end, the Parties to the Agreement are committed to continuous improvement in occupational health and safety standards through the implementation of an organisational framework which involves all Parties in protecting Employees’ health and safety.
Safety Objectives. The safety objectives of the study are to monitor and assure safety of subjects during and after the experimental sessions by assessing physiological effects, psychological distress, adverse events, spontaneously reported reactions and suicidality. • Suicidality will be assessed with the Columbia Suicide Severity Rating Scale (C- SSRS) during visits prior to experimental sessions, twice during experimental sessions, and several times after each experimental session, with comparisons made between subjects in each condition. • Subjective Units of Distress (SUD) and xxxxx xxxxx including blood pressure, heart rate and temperature will be measured during each experimental session, and xxxxx xxxxx will be compared between subjects in each condition. • Serious adverse events, adverse events and spontaneously reported reactions will be collected during the study according to Section 8.5.
Safety Objectives. All SAEs following exposure to mepolizumab, and any non-serious AEs related to mepolizumab, will be described (and reported as according to Section 5). Details of AE collection including definitions and timing will be described in the safety management plan. Analysis of AE data will be described in further detail in the SAP. The number and percentage of patients experiencing at least 1 AE of any type, AEs within each body system, and AEs within each preferred term will be collected as per eCRF.
Safety Objectives. The City and Union will cooperate in the continuing objective to eliminate accidents and health hazards. The City shall make reasonable provisions for the safety and health of its employees during the hours of their employment.
Safety Objectives. The study will monitor and ensure safety in subjects enrolled in the study by assessing physiological effects, psychological distress, spontaneously reported reactions, and suicidality. • Xxxxx xxxxx (blood pressure, heart rate, and temperature) and Subjective Units of Distress (SUD) will be measured during each experimental session. Comparisons will be made for SUD scores and xxxxx xxxxx between each condition. • SAEs, AEs, and spontaneously reported reactions will be collected during the study according to protocol Section 14.0. • Suicidality will be assessed with the Columbia Suicide Severity Rating Scale (C- SSRS) during visits prior to and after experimental sessions, twice during experimental sessions, and several times after each experimental session. Comparisons will be made for C-SSRS scores for subjects in each condition. The same schedule of assessment will be followed during Stage 2. • Assess cognitive function with the Paced Auditory Serial Addition Test (PASAT) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline and the primary endpoint by condition, and end of Stage 1/end of Stage 2 for maximal exposure. • Collect changes to pre-existing tinnitus and/or chronic pain symptoms using a visual analog scale, specifically in subjects with a medical history of tinnitus and/or chronic pain.
