Safety Analysis Clause Samples
The Safety Analysis clause requires a thorough evaluation of potential hazards and risks associated with a product, process, or activity. Typically, this involves identifying possible safety issues, assessing their likelihood and impact, and implementing measures to mitigate or eliminate these risks. For example, in a manufacturing contract, this clause might mandate regular safety audits or the use of specific safety protocols. Its core function is to ensure that all parties proactively address safety concerns, thereby reducing the likelihood of accidents, injuries, or regulatory violations.
Safety Analysis. The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 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. Individual subject listings will be provided for AEs that occur after signing informed consent but prior to exposure to study lenses. Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from baseline (Visit 2 or Visit 1, if Visit 2 and Visit 1 occur on the same date) to any subsequent visit will be presented. A supportive listing will be generated which will include all biomicroscopy data from all visits for these eyes experiencing the increase. Two listings (prior to exposure of study lenses and treatment-emergent) of device deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each device deficiency category will be tabulated. No inferential testing will be done for safety analysis.
Safety Analysis. The Engineer shall review and analyze historical crash data for latest 3 to 5 full calendar years (i.e., January 1 to December 31, inclusive) with respect to crash characteristics such as severity, crash types, frequency, rates, patterns, clusters, and their relationship to crash contributing factors. The purpose of the historical crash analyses is to determine safety performance of the existing conditions to understand any safety issues within the study area. Predictive, or quantitative safety analysis, involves using HSM-based methods that use safety performance functions (SPFs) and crash modification factors (CMFs) to estimate anticipated change in crashes from existing condition to the proposed design. The predictive safety analysis must be done for no-build and build conditions for design year. The purpose of the predictive safety analysis is to compare the safety performance of the no-build and build alternatives to help determine the preferred alternative and to determine the countermeasures, if necessary, to improve safety. Predictive safety analysis must be performed using HSM based tools including Interactive Highway Safety Design Model (IHSDM), Enhanced Interchange Safety Analysis Tools (ISATe), HSS, or other tools acceptable to the Owner. The Engineer shall develop and submit to the Owner a safety analysis report summarizing all analysis performed.
Safety Analysis. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs; · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable; Safety assessments for changes in physical examination, ▇▇▇▇▇ ▇▇▇▇▇, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. The results of anti-BA058 testing will be summarized. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group. Similar safety analyses will be conducted cumulatively at Months 12, 18, and 24 (i.e., Visits 4, 5, and 6). Full details of these analyses will be provided in the Statistical Analysis Plan.
Safety Analysis. The CONSULTANT will perform predictive safety analysis in accordance with the Highway Safety Manual (HSM)
Safety Analysis. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs. · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable. Safety assessments for changes in physical examination, ▇▇▇▇▇ ▇▇▇▇▇, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group. Similar safety analyses will be conducted cumulatively at Months 12, 18, and 24 (i.e., Visits 4, 5, and 6). Full details of these analyses will be provided in the Statistical Analysis Plan.
Safety Analysis. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs. · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable. Safety assessments for changes in physical examination, ▇▇▇▇▇ ▇▇▇▇▇, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group.
Safety Analysis. Transcend shall conduct detailed crash analysis for the 20 roadway segments and 20 intersections. Based on identified safety issues, we anticipate that up to 5 of these locations may need Road Safety Audit (RSA)s before countermeasures can be recommended. Average crash rates shall be developed to compare with statewide averages. Using FHWA’s Clearinghouse, countermeasures such as turn lanes, median installation, minor geometric modifications, lighting, speed control and signal phasing/timing adjustments will be identified for the prioritized list of locations.
Safety Analysis. All safety assessments, including AEs, SAEs, vital sign measurements, clinical laboratory results, physical examination results, concomitant medications, and 12-lead ECGs, will be tabulated, and summarized where possible, using descriptive methodology by renal function group and, as needed, by timepoint. Unless otherwise specified, baseline value is defined as the last non-missing measurement before administration of LOXO-305. No formal statistical analyses are planned for the safety data. All safety data will be listed by subject. Concomitant medications will be coded using the World Health Organization (WHO) Drug Dictionary (WHO Drug Global B3, September 2019). Adverse events will be coded using Medical Dictionary for Regulatory Activities Version (MedDRA) 22.1 (or higher). The incidence of AEs for each renal function group (matched control healthy subjects, mild, moderate, and severe) will be presented by severity and by relationship to study drug as determined by the Investigator or designee (Appendix 1 for AE reporting). All TEAEs will be summarized by system organ class and preferred term, with a breakdown by renal function group.
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. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs; · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable; Safety assessments for changes in physical examination, ▇▇▇▇▇ ▇▇▇▇▇, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. The results of anti-BA058 testing will be summarized. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group.