SAE Reporting 2. Informes SAE Sample Clauses

SAE Reporting 2. Informes SAE. All SAEs will be reported to Ultragenyx by completing and submitting MedWatch 3500A or CIOMS I report forms. SAE reports must be as complete as possible, at minimum including the SAE term(s), patient identifier, seriousness criteria, date of event onset, causality and expectedness assessment between each reported SAE term and Investigational Product, and name of the reporter (Physician). Information not available at the time of the initial report will be documented on a follow-up report and submitted to Ultragenyx (and/or regulatory authorities, IRB/EC, accordingly) as specified in Table 1. Additional information will include SAE stop date(s), outcome for each reported SAE, dates when Investigational Product was first received and the last dose prior to event onset, and action taken with Investigational Product as a result of the SAE. If applicable, the Institution and/or Physician protocol number will be included in all MedWatch Form 3500A or CIOMS I reports. Todos los EAE se notificarán a Ultragenyx completando y enviando los formularios de informe MedWatch 3500A o CIOMS I. Los informes de EAE deben ser lo más completos posible, incluyendo como mínimo el término de EAE, el identificador del paciente, los criterios de gravedad, la fecha de inicio del evento, la evaluación de la causalidad y la previsibilidad entre cada término de EAE informado y el producto de investigación, y el nombre del informante (médico). La información que no esté disponible en el momento del informe inicial se documentará en un informe de seguimiento y se presentará a Ultragenyx (y/o a las autoridades reguladoras, IRB/EC, según corresponda) como se especifica en la Tabla 1. La información adicional incluirá la(s) fecha(s) de interrupción del EAE, el resultado de cada EAE notificado, las fechas en que se recibió por primera vez el Producto de Investigación y la última dosis antes de la aparición del evento, y las medidas tomadas con el Producto de Investigación como resultado del EAE. Si procede, se incluirá el número de protocolo de la institución y/o del médico en todos los informes del formulario 3500A de MedWatch o del CIOMS I. SAEs with fatal and/or life-threatening outcomes, as defined in Applicable Laws and regulations, occurring during treatment, regardless of causality or expectedness will be reported to Ultragenyx within 24 hours of event knowledge. In addition, SAEs meeting SUSAR criteria, as defined by Applicable Laws and regulations, occurring during treatment, will be...
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Related to SAE Reporting 2. Informes SAE

  • Project Monitoring Reporting Evaluation A. The Project Implementing Entity shall monitor and evaluate the progress of its activities under the Project and prepare Project Reports in accordance with the provisions of Section 5.08(b) of the General Conditions and on the basis of indicators agreed with the Bank. Each such report shall cover the period of one

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • Reporting TIPS Sales Vendor must report all TIPS Sales to TIPS. If a TIPS sale is initiated by Vendor receiving a TIPS Member’s purchase order from TIPS directly, Vendor may consider that specific TIPS Sale reported. Otherwise, with the exception of TIPS Automated Vendors, who have signed an exclusive agreement with TIPS regarding reporting, all TIPS Sales must be reported to TIPS by either: (1) Emailing the purchase order or similar purchase document (with Vendor’s Name, as known to TIPS, and the TIPS Contract Name and Number included) to TIPS at xxxxxx@xxxx-xxx.xxx with “Confirmation Only” in the subject line of the email within three business days of Vendor’s acceptance of the order, or; (2) Within 3 business days of the order being accepted by Vendor, Vendor must login to the TIPS Vendor Portal and successfully self-report all necessary sale information within the Vendor Portal and confirm that it shows up accurately on your current Vendor Portal statement. No other method of reporting is acceptable unless agreed to by the Parties in writing. Failure to report all sales pursuant to this provision may result in immediate cancellation of Vendor’s TIPS Contract(s) for cause at TIPS’ sole discretion. Please refer to the TIPS Accounting FAQ’s for more information about reporting sales and if you have further questions, contact the Accounting Team at xxxxxxxxxx@xxxx-xxx.xxx.

  • Time Reporting ‌ The Employer may require employees to accurately report time worked in accordance with a positive time reporting process as determined by the Agency.

  • Meteorological Data Reporting Requirement (Applicable to wind generation facilities only) The wind generation facility shall, at a minimum, be required to provide the Transmission Provider with site-specific meteorological data including: • Temperature (degrees Fahrenheit) • Wind speed (meters/second) • Wind direction (degrees from True North) • Atmosphere pressure (hectopascals) • Forced outage data (wind turbine and MW unavailability)

  • EDD Independent Contractor Reporting Requirements Effective January 1, 2001, the County of Orange is required to file in accordance with subdivision (a) of Section 6041A of the Internal Revenue Code for services received from a “service provider” to whom the County pays $600 or more or with whom the County enters into a contract for $600 or more within a single calendar year. The purpose of this reporting requirement is to increase child support collection by helping to locate parents who are delinquent in their child support obligations. The term “service provider” is defined in California Unemployment Insurance Code Section 1088.8, subparagraph B.2 as “an individual who is not an employee of the service recipient for California purposes and who received compensation or executes a contract for services performed for that service recipient within or without the state.” The term is further defined by the California Employment Development Department to refer specifically to independent Contractors. An independent Contractor is defined as “an individual who is not an employee of the ... government entity for California purposes and who receives compensation or executes a contract for services performed for that ... government entity either in or outside of California.” The reporting requirement does not apply to corporations, general partnerships, limited liability partnerships, and limited liability companies. Additional information on this reporting requirement can be found at the California Employment Development Department web site located at xxxx://xxx.xxx.xx.xxx/Employer_Services.htm

  • Reporting Frequency During any period of time when you are subject to the requirement in paragraph 1 of this award term and condition, you must report proceedings information through XXX for the most recent five year period, either to report new information about any proceeding(s) that you have not reported previously or affirm that there is no new information to report. Recipients that have Federal contract, grant, and cooperative agreement awards with a cumulative total value greater than $10,000,000 must disclose semiannually any information about the criminal, civil, and administrative proceedings.

  • ADDITIONAL REPORTING REQUIREMENTS Contractor agrees to submit written quarterly reports to H-GAC detailing all transactions during the previous three (3) month period. Reports must include, but are not limited, to the following information:

  • Contractor Sales Reporting Vendor Management Fee Contractor Reports Master Contract Sales Reporting. Contractor shall report total Master Contract sales quarterly to Enterprise Services, as set forth below. Master Contract Sales Reporting System. Contractor shall report quarterly Master Contract sales in Enterprise Services’ Master Contract Sales Reporting System. Enterprise Services will provide Contractor with a login password and a vendor number. The password and vendor number will be provided to the Sales Reporting Representative(s) listed on Contractor’s Bidder Profile. Data. Each sales report must identify every authorized Purchaser by name as it is known to Enterprise Services and its total combined sales amount invoiced during the reporting period (i.e., sales of an entire agency or political subdivision, not its individual subsections). The “Miscellaneous” option may be used only with prior approval by Enterprise Services. Upon request, Contractor shall provide contact information for all authorized purchasers specified herein during the term of the Master Contract. If there are no Master Contract sales during the reporting period, Contractor must report zero sales. Due dates for Master Contract Sales Reporting. Quarterly Master Contract Sales Reports must be submitted electronically by the following deadlines for all sales invoiced during the applicable calendar quarter: For Calendar Quarter Ending Master Contract Sales Report Due March 31: April 30 June 30: July 31 September 30: October 31 December 31: January 31 Vendor Management Fee. Contractor shall pay to Enterprise Services a vendor management fee (“VMF”) of 0.74 percent on the purchase price for all Master Contract sales (the purchase price is the total invoice price less applicable sales tax). The sum owed by Contractor to Enterprise Services as a result of the VMF is calculated as follows: Amount owed to Enterprise Services = Total Master Contract sales invoiced (not including sales tax) x .0074. The VMF must be rolled into Contractor’s current pricing. The VMF must not be shown as a separate line item on any invoice unless specifically requested and approved by Enterprise Services. Enterprise Services will invoice Contractor quarterly based on Master Contract sales reported by Contractor. Contractors are not to remit payment until they receive an invoice from Enterprise Services. Contractor’s VMF payment to Enterprise Services must reference this Master Contract number, work request number (if applicable), the year and quarter for which the VMF is being remitted, and the Contractor’s name as set forth in this Master Contract, if not already included on the face of the check. Failure to accurately report total net sales, to submit a timely usage report, or remit timely payment of the VMF, may be cause for Master Contract termination or the exercise of other remedies provided by law. Without limiting any other available remedies, the Parties agree that Contractor’s failure to remit to Enterprise Services timely payment of the VMF shall obligate Contractor to pay to Enterprise Services, to offset the administrative and transaction costs incurred by the State to identify, process, and collect such sums. the sum of $200.00 or twenty-five percent (25%) of the outstanding amount, whichever is greater, or the maximum allowed by law, if less. Enterprise Services reserves the right, upon thirty (30) days advance written notice, to increase, reduce, or eliminate the VMF for subsequent purchases, and reserves the right to renegotiate Master Contract pricing with Contractor when any subsequent adjustment of the VMF might justify a change in pricing.

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