Suspected Unexpected Serious Adverse Reaction Sample Clauses

Suspected Unexpected Serious Adverse Reaction. (SUSAR) A suspected unexpected serious drug reaction (SUSAR) is defined as a SAE that is suspected to be an ADR, but is not consistent with the information as provided in the Investigators’ Brochure - i.e. either is not listed as an expected ADR in the Investigator’s Brochure, occurred at a greater severity than was listed, or there is an increase in the rate of occurrence that is judged to be clinically important. All SUSARs must be reported to the applicable regulatory agencies within the timelines as stipulated by local law and guidelines by the Sponsor, and reported to each IRB / IEC by each Investigator.
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Related to Suspected Unexpected Serious Adverse Reaction

  • Serious Health Condition An illness, injury, impairment, or physical or mental condition which warrants the participation of a family member to provide care during a period of treatment or supervision and involves either inpatient care in a hospital, hospice or residential health care facility or continuing treatment or continuing supervision by a health care provider (e.g. physician or surgeon) as defined by state and federal law.

  • Expected Outcomes The educational goals and objectives for improving student achievement, including how much academic improvement students are expected to show each year, how student progress and performance will be evaluated and the specific results to be attained, as described in Section 5a of the application: Student Performance, Assessment and Evaluation.

  • Professional Development; Adverse Consequences of School Exclusion; Student Behavior The Board President or Superintendent, or their designees, will make reasonable efforts to provide ongoing professional development to Board members about the adverse consequences of school exclusion and justice-system involvement, effective classroom management strategies, culturally responsive discipline, appropriate and available supportive services for the promotion of student attendance and engagement, and developmentally appropriate disciplinary methods that promote positive and healthy school climates, i.e., Senate Bill 100 training topics. Board Self-Evaluation The Board will conduct periodic self-evaluations with the goal of continuous improvement. New Board Member Orientation The orientation process for newly elected or appointed Board members includes:

  • Expected Outcome With this waiver, the school will be able to implement its program and evaluate its teachers in accordance with its Performance Appraisal System, which is designed to produce greater accountability and be consistent with the school’s goals and objectives. This will benefit staff members as well as students and the community. Non-Automatic Waivers: Statute Description and Rationale and Replacement Plan

  • Independence from Material Breach Determination Except as set forth in Section X.D.1.c, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for OIG’s decision that CHSI has materially breached this CIA, which decision shall be made at OIG’s discretion and shall be governed by the provisions in Section X.D, below.

  • Serious Illness Should a participant be unable to take the leave when scheduled because of serious injury or illness occurring before commencement of the leave, he/she may cancel the leave and receive payment as in Article 12.8.3.9 or, with the consent of the College, defer the leave to a time mutually agreeable, not to exceed one (1) year.

  • FLORIDA CONVICTED/SUSPENDED/DISCRIMINATORY COMPLAINTS By submission of an offer, the respondent affirms that it is not currently listed in the Florida Department of Management Services Convicted/Suspended/Discriminatory Complaint Vendor List.

  • Reporting Unsuccessful Security Incidents Business Associate shall provide Covered Entity upon written request a Report that: (a) identifies the categories of Unsuccessful Security Incidents; (b) indicates whether Business Associate believes its current defensive security measures are adequate to address all Unsuccessful Security Incidents, given the scope and nature of such attempts; and (c) if the security measures are not adequate, the measures Business Associate will implement to address the security inadequacies.

  • Mitigation of Harmful Effects To mitigate, to the extent practicable, any harmful effect 8 that is known to CONTRACTOR of a use or disclosure of DHCS PI or PII by CONTRACTOR or its 9 subcontractors in violation of this Personal Information Privacy and Security Contract.

  • Infectious Disease Where an employee produces documentary evidence that:

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