Reporting of Serious Adverse Events Sample Clauses

Reporting of Serious Adverse Events. 5.10.1 Reporting to the Sponsor All SAEs, which include SUSARs, are reported to the Sponsor for the entire study period. SUSARs are reported even after the study is over, if the Sponsor, local Medical Monitor or Principal Investigator becomes aware of them. The study site will be provided with specific reporting procedures including the SAE paper form and any supplemental reporting forms to be used. SAEs will be reported on the SAE paper form and the AE eCRF using a recognised medical term or diagnosis that accurately reflects the event. XXXx will be assessed for severity, causal relationship to the study vaccine, and expectedness by the Investigator and the local Medical Monitor according to their roles (as described in Section 5.1.1 and Section 5.1.3). The onset and resolution dates of the event and medical care taken in response to the event will be documented. If the event has not resolved by the end of the influenza season the participant is enrolled into, it will be documented as “ongoing” on the eCRF, however, follow-up of the SAE must continue until resolved or the condition has stabilised. Information recorded on the eCRF must be substantiated in the source documents. The SAE form for that event must be completed by the Principal Investigator, within one business day of the study site becoming aware of the event. The SAE form should be completed with all information known at the time. and scanned and emailed to xxxxxx@xxxxxxxx.xxx.xx. Fatal or life-threatening SAEs that the Investigator suspects are related to the study vaccine should be telephoned to the local Medical Monitor immediately upon the Investigator’s awareness of the event. If the local Medical Monitor is required by the protocol or chooses to suspend enrolment s/he shall immediately create a written memorandum for record to the study file and telephonically notify the Sponsor of this act. Contact information for all safety personnel are contained in the Team Contact List, which will be stored at the study site in the Site Regulatory Binder and maintained by the study Sponsor. Investigators must not wait to collect additional information to fully document the event before notifying the local Medical Monitor of an SAE. The initial notification should include the following (at minimum): • Protocol number and name and contact number of the Investigator • Participant identification number (and initials and date of birth, if available) • Date participant received investigational product • S...
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Reporting of Serious Adverse Events. All SAEs (as defined below) regardless of treatment group or suspected relationship to IMP must be reported immediately (within 24 hours of the investigator’s knowledge of the event) to the pharmacovigilance contact specified at the beginning of this protocol. If the immediate report is submitted by telephone, this must be followed by detailed written reports using the SAE report form. An SAE is any AE that:
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Reporting of Serious Adverse Events. If a Serious Adverse Event (“SAE”) occurs during any Study, it shall be reported without undue delay (i.e., within 1 business day after Study Site becomes aware of such SAE) to the designated pharmacovigilance unit at the CRO or at Sponsor or at any other third party designated by Sponsor and identified to Study Site. The Study Site shall answer any possible questions relevant to such SAE to its best knowledge.
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Reporting of Serious Adverse Events. This Section 4.7 applies only to interventional clinical Studies that involve the use of a Pfizer Product (see Section 6, Pfizer Product or Compound), whether Pfizer supplies the product or not. Different requirements will apply to prospective or retrospective non- interventional studies that focus on a Pfizer Product or if an interventional study involves a certain type of Pfizer product (ie, a product that is or includes a medical device, certain long-marketed oncology products with a well established safety profile, and certain in-licensed products). Any such differing requirements will be documented in the Study Order for the affected Study.
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Reporting of Serious Adverse Events. Any AE considered serious by the investigator or which meets SAE criteria (Section 6.2.1.1), or any other event or condition regardless of grade, which in their judgment represents a reportable event, must be reported to the medical monitor and SIGA as soon as the investigator becomes aware of the event. In addition, the event must be reported to PPD via the SAE hotline. The PPD SAE Report Form must be submitted within 24 hours of knowledge of the event. SIGA (or designee) will be responsible for notifying the relevant regulatory authorities of any SAE as outlined in US Title 21 Code of Federal Regulations (CFR) Parts 312 and 320. The investigator is responsible for notifying the institutional review board (IRB) directly. In addition, the investigator (or designee) must report any Grade 3 (severe) AE that they deem possibly, probably, or definitely related to study drug to the medical monitor and SIGA within 24 hours after becoming aware of the event. • Grade 3 (Severe): Events interrupt a subject’s usual daily activity, may require systemic drug therapy or other treatment, and are usually incapacitating. • Grade 4 (Life-threatening): Event that, in the opinion of the investigator, places the subject at immediate risk of death from the reaction as it occurred (ie, it does not include a reaction that, had it occurred in a more severe form, might have caused death). • Grade 5 (Death). Changes in the severity of an AE should be documented to allow an assessment of the duration of the event at each level of intensity to be performed. An AE characterized as intermittent requires documentation of onset and duration of each episode.
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Reporting of Serious Adverse Events. The investigator is responsible for reporting all SAEs observed by the investigator or reported by the subject. Unless otherwise indicated in Table 6 below, all SAEs will be reported within 24 hours and recorded in the CRF.
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Reporting of Serious Adverse Events. ‌ Every SAE, regardless of the causal relationship to the study treatment, occurring after the patient has signed informed consent, until at least 30 days after the patient has stopped study treatment, must be reported to the Karyopharm Pharmacovigilance Department with the timeframe not to exceed 24 hours of the Investigator becoming aware of the event. The investigational site personnel must use the SAE Report Form provided by Karyopharm for reporting any SAE to the Karyopharm Pharmacovigilance Department. Upon completion, the SAE Report Form must be immediately emailed or faxed to: Pharmacovigilance Department Karyopharm Therapeutics Inc. Email: xxxxxxxxxxxxxxxxx@xxxxxxxxxx.xxx Fax: +0-000-000-0000 (USA) +00-00-0000-0000 (Germany) Any SAE observed after the 30-day follow-up period should only be reported to Karyopharm if the Investigator suspects that the SAE has a causal relationship to the study treatment. Recurrent episodes, complications, or progression of the initial SAE must be reported, as follow-up to the original episode, within 24 hours of the Investigator receiving the follow-up information. An SAE should be followed until its resolution or until it is judged to be permanent. An assessment should be made at each study visit (or more frequently, if necessary) of any changes in severity of the event, the suspected relationship to the study treatment, the interventions required to treat the event, and the outcome of the event.
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Reporting of Serious Adverse Events. In agreeing to the provisions of this protocol, the Investigator accepts all legal responsibilities for immediately reporting of SAEs to La Jolla. Immediate reporting implies within 24 hours of becoming aware of the occurrence of a SAE. All SAEs that occur from initiation of study drug treatment, during treatment, and through the Day 28 follow-up, regardless of the causal relationship to the investigational product, must be reported to La Jolla by following the instructions provided in this Section. Redacted medical record source documentation will be requested for all SAEs and emergency room visits. The method for reporting a SAE is by completing and sending the Serious Adverse Event Report Form and completing the AE CRF. The Serious Adverse Event Report Form and if applicable, a copy of redacted source documents (such as hospital discharge summary, medical records, etc.) related to the SAE will be sent as: • e-mail to: xxxxxx@xxxx.xxx; or • fax to: +0 (000) 000-0000 The Investigator will assess whether the event is causally related to the investigational product. La Jolla will also assess whether the event is causally related to the investigational product, in addition to assessing the overall safety profile of the investigational product. La Jolla will notify the appropriate regulatory authorities in accordance with country regulations. It is the Investigator’s responsibility to notify the IRB or independent ethics committee (IEC) of all SAEs that occur at his or her site, according to local requirements. Investigators will be informed about SAEs according to applicable local regulations. Each site is responsible for notifying its IRB/IEC of these additional SAEs, per local policy. Following the initial report, any additional information obtained by the Investigator about the SAE must be reported promptly to La Jolla in the same manner as described above for the initial SAE report.
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Related to Reporting of Serious Adverse Events

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • Notification of Events of Default and Adverse Developments The Borrower shall promptly notify the Lender upon obtaining knowledge of the occurrence of:

  • Material Adverse Events Since the date of the latest audited financial statements included within the SEC Reports, except as specifically disclosed in a subsequent SEC Report filed prior to the date hereof, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or required to be disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any officer, director or “Affiliate” (defined as any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 144 under the Act), except pursuant to existing Company stock option plans. The Company does not have pending before the Commission any request for confidential treatment of information. No event, liability or development has occurred or exists with respect to the Company or its Subsidiaries or their respective business, properties, operations or financial condition, that would be required to be disclosed by the Company under applicable securities laws at the time this representation is deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation is deemed made.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Absence of Material Adverse Change On the Closing Date, no circumstance shall exist that constitutes a REIT II Material Adverse Effect.

  • Suspension of Sales; Adverse Disclosure Upon receipt of written notice from the Company that a Registration Statement or Prospectus contains a Misstatement, each of the Holders shall forthwith discontinue disposition of Registrable Securities until he, she or it has received copies of a supplemented or amended Prospectus correcting the Misstatement (it being understood that the Company hereby covenants to prepare and file such supplement or amendment as soon as practicable after the time of such notice), or until he, she or it is advised in writing by the Company that the use of the Prospectus may be resumed. If the filing, initial effectiveness or continued use of a Registration Statement in respect of any Registration at any time would require the Company to make an Adverse Disclosure or would require the inclusion in such Registration Statement of financial statements that are unavailable to the Company for reasons beyond the Company’s control, the Company may, upon giving prompt written notice of such action to the Holders, delay the filing or initial effectiveness of, or suspend use of, such Registration Statement for the shortest period of time, but in no event more than thirty (30) days, determined in good faith by the Company to be necessary for such purpose. In the event the Company exercises its rights under the preceding sentence, the Holders agree to suspend, immediately upon their receipt of the notice referred to above, their use of the Prospectus relating to any Registration in connection with any sale or offer to sell Registrable Securities. The Company shall immediately notify the Holders of the expiration of any period during which it exercised its rights under this Section 3.4.

  • Notice of Material Adverse Change Promptly inform Lender of (i) any and all material adverse changes in Borrower’s financial condition, and (ii) all claims made against Borrower which could materially affect the financial condition of Borrower.

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