Expedited Reporting of Serious Adverse Events Sample Clauses

Expedited Reporting of Serious Adverse Events. ‌ Regulations require that VentiRx Pharmaceuticals or its representatives to report any suspected adverse reactions1 that are both serious (§8.1) and unexpected (§8.4). Such events must be reported to the FDA, applicable regulatory authorities, and all participating investigators (i.e., all investigators to whom VentiRx is providing drug under its INDs or under any investigator’s IND) within 15 calendar days after VentiRx or its representative receives the information and determines that it qualifies for reporting. Such notification must occur within 7 calendar days if the SUSAR was fatal or life-threatening.
Sample 1
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Expedited Reporting of Serious Adverse Events. RIBOMIC (or designee) will provide the Principal Investigator with a reporting cover letter and an anonymized MedWatch 3500A for expedited reporting of SAEs to the IRB or Independent Ethics Committee (IEC). The Principal Investigator is responsible for receiving and reviewing expedited safety reports, submitting expedited safety reports to the IRB or IEC, and maintaining copies of expedited safety reports in the study records.
Sample 1

Related to Expedited Reporting of Serious Adverse Events

  • Reporting of Reportable Events If Xxxxx determines (after a reasonable opportunity to conduct an appropriate review or investigation of the allegations) through any means that there is a Reportable Event, Xxxxx shall notify OIG, in writing, within 30 days after making the determination that the Reportable Event exists.

  • Reporting of Non-Force Majeure Events Each Party (the “Notifying Party”) shall notify the other Parties when the Notifying Party becomes aware of its inability to comply with the provisions of this Agreement for a reason other than a Force Majeure event. The Parties agree to cooperate with each other and provide necessary information regarding such inability to comply, including the date, duration, reason for the inability to comply, and corrective actions taken or planned to be taken with respect to such inability to comply. Notwithstanding the foregoing, notification, cooperation or information provided under this Article shall not entitle the Party receiving such notification to allege a cause for anticipatory breach of this Agreement.

  • REPORTING OF ACCIDENTS The Contractor shall report to the Engineer details of any accident as soon as possible after its occurrence. In the case of any fatality or serious accident, the Contractor shall, in addition, notify the Engineer immediately by the quickest available means. The Contractor shall also notify the relevant authority whenever the Laws of Kenya require such a report.

  • 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.

  • 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:

  • Reporting of Unauthorized Disclosure The Contractor shall immediately report to the State any unauthorized disclosure of confidential information.

  • Extended Reporting Period If any required insurance coverage is on a claims-made basis (rather than occurrence), Contractor shall maintain such coverage for a period of no less than three (3) years following expiration or termination of the Master Contract.

  • 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.

  • Portability of Service An employee hired by the Hospital with recent and related experience may claim consideration for such experience at the time of hiring on a form to be supplied by the Hospital. Any such claim shall be accompanied by verification of previous related experience. The Hospital shall then evaluate such experience during the probationary period following hiring. Where in the opinion of the Hospital such experience is determined to be relevant, the employee shall be slotted in that step of the wage progression consistent with one (1) year's service for every one (1) year of related experience in the classification upon completion of the employee's probationary period. It is understood and agreed that the foregoing shall not constitute a violation of the wage schedule under the collective agreement."

  • Reporting of Claims Consultant shall report to the City, in addition to Consultant’s insurer, any and all insurance claims submitted by Consultant in connection with the Services under this Agreement.

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