Reporting of Serious Adverse Events Sample Clauses

Reporting of Serious Adverse Events. 5.10.1 Reporting to the Sponsor
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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: 1) Results in death 2) Is life threatening, that is any event that places the subject at immediate risk of death from the event as it occurred. It does not include an event that, had it occurred in a more severe form, might have caused death 3) Results in in-patient hospitalisation or prolongation of existing hospitalisation, excluding admission for social or administrative reasons (see further) 4) Results in a persistent or significant disability/incapacity, where disability is a substantial disruption of a person’s ability to conduct normal life functions 5) Results in congenital anomaly/birth defect in the offspring of a subject who received the IMP 6) Is an important medical event that may not result in death, be life threatening, or require hospitalisation when, based upon appropriate medical judgement, may jeopardise the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in in-patient hospitalisation, or the development of drug dependency or drug abuse. In addition to the above criteria, any additional AE that the sponsor or an investigator considers serious should be immediately reported to the sponsor and included in the corporate SAEs database system. • Hospitalisation is defined as any in-patient admission (even if less than 24 hours). For chronic or long-term in-patients, in-patient admission also includes transfer within the hospital to an acute/intensive care in-patient unit • Prolongation of hospitalisation is defined as any extension of an in-patient hospitalisation beyond the stay anticipated/required in relation to the original reason for the initial admission, as determined by the investigator or treating physician. For protocol-specified hospitalisation in clinical studies, prolongation is defined as any extension beyond the length of stay described in the protocol. Prolongation in the absence of a...
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. The investigational site personnel must use the SAE Report Form (paper or electronic) provided by Karyopharm for reporting any SAE to the Karyopharm Pharmacovigilance Department. The immediate report should be made by the investigator within a very short period of time and under no circumstances should this exceed 24 hours following knowledge of the SAE. After the 30-day follow-up period SAEs should only be reported to Karyopharm if the Investigator suspects that the SAE has a causal relationship to the study treatment. To complete the electronic SAE Report Form, a Log Line must first be completed in the Adverse Events eCRF. The SAE will then be linked to an electronic SAE Report Form. It is then necessary to complete a Log Line in the corresponding SAE Report Form eCRF within 24 hours of learning of the SAE’s occurrence. It is not necessary to submit a paper SAE Report Form if the SAE was originally declared using the electronic SAE Report Form. If the SAE is to be reported via a paper SAE Report Form, upon completion, the SAE Report Form must be immediately emailed or faxed to: Email: xxxxxxxxxxxxxxxxx@xxxxxxxxxx.xxx Fax: +0-000-000-0000 (USA) +00-00-0000-0000 (Germany) 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
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.
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.
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: Email: xxxxxxxxxxxxxxxxx@xxxxxxxxxx.xxx Fax: +0-000-000-0000 (USA) 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.
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. 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.
Reporting of Serious Adverse Events 

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.

  • 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.

  • 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.

  • Absence of Material Adverse Changes No material adverse change in the business, assets, financial condition, or prospects of the Company shall have occurred, no substantial part of the assets of the Company not substantially covered by insurance shall have been destroyed due to fire or other casualty, and no event shall have occurred which has had or will have a material adverse effect on the business, assets, financial condition or prospects of the Company.

  • 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.

  • 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.

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

  • Reporting of Compliance Matters (a) The Sub-Adviser shall promptly provide to the Trust’s Chief Compliance Officer (“CCO”) the following documents: (i) copies of all SEC examination correspondences, including correspondences regarding books and records examinations and “sweep” examinations, issued during the term of this Agreement, in which the SEC identified any concerns, issues or matters (such correspondences are commonly referred to as “deficiency letters”) relating to any aspect of the Sub-Adviser’s investment advisory business and the Sub-Adviser’s responses thereto; (ii) a report of any material violations of the Sub-Adviser’s Compliance Program or any “material compliance matters” (as such term is defined in Rule 38a-1 under the 0000 Xxx) that have occurred with respect to the Sub-Adviser’s Compliance Program; (iii) a report of any material changes to the policies and procedures that compose the Sub-Adviser’s Compliance Program; (iv) a copy of the Sub-Adviser’s chief compliance officer’s report (or similar document(s) which serve the same purpose) regarding his or her annual review of the Sub-Adviser’s Compliance Program, as required by Rule 206(4)-7 under the Advisers Act; and (v) an annual (or more frequently as the Trust’s CCO may reasonably request) representation regarding the Sub-Adviser’s compliance with Paragraphs 7 and 8 of this Agreement. (b) The Sub-Adviser shall also provide the Trust’s CCO with: (i) reasonable access to the testing, analyses, reports and other documentation, or summaries thereof, that the Sub-Adviser’s chief compliance officer relies upon to monitor the effectiveness of the implementation of the Sub-Adviser’s Compliance Program; and (ii) reasonable access, during normal business hours, to the Sub-Adviser’s facilities for the purpose of conducting pre-arranged on-site compliance related due diligence meetings with personnel of the Sub-Adviser.

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