Safety Assessments. Covered 1915(b)(3) Waiver (alternative) Services
Safety Assessments. 10.1 MoD should be made aware of any potential safety issues arising due to proposed modifications/new design and should be informed of all measures required in order to limit the risk to safety and supply supporting evidence as required in order that a safety assessment/safety case can be conducted. The Contractor may be asked to participate as the Subject Matter Expert in a formal safety assessment, which should be carried out in accordance with Xxx Xxxx. 00-56 Issue 2 and JSP430 Issue 3. MPS-MES-ESG-CS can be contacted for assistance in regard to participating with the safety assessment.
Safety Assessments. The Contractor will be required to provide safety related information to support the future safety assessments of the systems supported under this SOTR, including addressing the system installation and operation. The Contractor will be required to participate in safety assessments/cases on the equipment supplied and supported in accordance with JSP 430 and XXX XXXX 00-56 issue 4.
Safety Assessments. Contractor will provide crisis psychotherapy evaluations for inmates determined by County employees to be at risk of harm to self or others, or to be suffering from serious acute behavioral health disorders. Contractor will supply Ravalli County Detention Center staff with safety recommendations. Contractor will seek diversion of inmates whose psychiatric needs exceed the care capacity at the detention center.
Safety Assessments. 9.2.1 Physical Examination Assessments [***] [***] [***] [***] W-week, ET-early termination
9.2.2 Clinical Laboratory & Other Safety Assessments [***] Confidential Information Protocol version 1.1, 21 Aug 2012 Protocol VB-201-064 VB-201 [***] [***] [***] [***] Confidential Information Protocol version 1.1, 21 Aug 2012 Protocol VB-201-064 VB-201
Safety Assessments. Planned time points for all safety assessments are provided in the SoA (Section 1.3). Study procedures should be completed within the windows provided in the SoA and as specified in this section.
Safety Assessments. Planned time points for all safety assessments are provided in the SoA (Section 1.3). When multiple procedures are scheduled to occur at the same time, the following order of events should be strictly adhered to whenever possible: ECG, vital signs, blood sampling, study intervention administration, and meal. PK collection should occur as close as possible to the scheduled time. All routine safety laboratory samples should be drawn following a minimum of 8 hours fasting.
Safety Assessments. Safety and tolerability will be assessed by monitoring and recording of AEs, clinical laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature), 12-lead ECG results, and physical examination findings.
Safety Assessments. Safety assessments conducted during this study include collection of AEs, vital sign measurements, symptom-directed physical examinations, electrocardiograms, clinical laboratory assessments, and Eastern Cooperative Oncology Group performance status. Cycle/Visita Screening Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 Subsequent Cycles EOT Safety Follow -up Survival Assessment Informed consent X Inclusion/Exclusion criteria X X Demographics X Medical, surgical, cancer, and medication history X
Safety Assessments. Safety will be assessed by monitoring and recording of AEs, vital sign measurements, 12- lead ECG results, physical examination findings, and clinical laboratory test results (hematology, coagulation, serum chemistry, and urinalysis). For all safety assessments, the investigator will determine whether results are clinically significant, which is defined as any variation in a result that has medical relevance and may result in an alteration in medical care (e.g., active observation, diagnostic measures, or therapeutic measures). If clinical significance is noted, the result and reason for significance will be documented and an AE reported on the AE page of the subject’s eCRF. The investigator will monitor the subject until the result has reached the reference range or the result at screening, or until the investigator determines that follow-up is no longer medically necessary.
