Regulatory Reporting Requirements for SAEs Sample Clauses

Regulatory Reporting Requirements for SAEs. Prompt notification of an SAE by the investigator to the Sponsor is essential so that the Sponsor’s legal obligations and ethical responsibilities toward the safety of subjects and the safety of study treatment under clinical investigation can be met. • The Sponsor has a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of a study treatment under clinical investigation. The Sponsor will comply with country-specific regulatory requirements relating to safety reporting to regulatory authorities, IRB/IEC, and investigators. • Investigator safety reports must be prepared for SUSARs (defined in Section 10.3.3) according to local regulatory requirements and Sponsor policy and forwarded to investigators as necessary. • An investigator who receives an investigator safety report describing an SAE or other specific safety information (eg, summary or listing of SAEs) from the Sponsor will review and then file it along with the IB and will notify the IRB/IEC, if appropriate, according to local requirements.
Sample 1
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Related to Regulatory Reporting Requirements for SAEs

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

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  • 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:

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  • 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)

  • Child Abuse Reporting Requirement Grantee will:

  • Special Reporting Requirements County shall prepare and electronically submit, to xxxxxxxxxxx.xxxxxxxxxxxxx@xxxxxx.xxxxx.xx.xx, written quarterly reports on the delivery of MHS 04 Services, no later than 45 calendar days following the end of each subject quarter for which financial assistance is awarded through this Agreement. Reports must be prepared using forms and procedures prescribed by OHA. Forms are located at xxxx://xxx.xxxxxx.xxx/OHA/HSD/AMH/Pages/Reporting-Requirements.aspx. Each quarterly report shall provide the following information per month for each subject quarter:

  • EDD Independent Subrecipient 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 Subrecipients. An independent Subrecipient 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

  • General Reporting Requirements The MA-PD Sponsor agrees to submit to information to CMS according to 42 CFR §§423.505(f), 423.514, and the "Final Medicare Part D Reporting Requirements," a document issued by CMS and subject to modification each program year.

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