SERIOUS ADVERSE EVENT REPORT definition

SERIOUS ADVERSE EVENT REPORT means any Adverse Event Report that involves an Adverse Event that is fatal or life-threatening, a persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization, or is a congenital anomaly/birth defect, or any other medically important event that can be regarded as serious, even though it does not meet any of the above criteria.
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SERIOUS ADVERSE EVENT REPORT means any oral, written or electronically transmitted report of any Serious Adverse Event.
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SERIOUS ADVERSE EVENT REPORT means an adverse drug experience reported to the FDA or other corresponding Governmental Authority occurring at any dose that results in any of the following outcomes: death; a life-threatening adverse drug experience; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability and/or incapacity; a congenital anomaly and/or birth defect; or any other important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the other outcomes listed.
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Examples of SERIOUS ADVERSE EVENT REPORT in a sentence

  • Appendix M: Subject Diary‌ Appendix N: SAMPLE SERIOUS ADVERSE EVENT REPORT FORM‌‌ Appendix O: PREGNANCY NOTIFICATION FORM‌‌Appendix P: LACTATION NOTIFICATION FORM‌‌ Celgene Signing PageThis is a representation of an electronic record that was signed electronically in Livelink.This page is the manifestation of the electronic signature(s) used in compliance with the organizations electronic signature policies and procedures.

  • The investigator will comply with applicable laws/requirements for reporting serious adverse events (SAEs) to the ECs. ALL SAEs ARE TO BE REPORTED ON THE SERIOUS ADVERSE EVENT REPORT (SAER) FORM ANDTRANSMITTED TO THE SPONSORWITHIN 24 HOURS OF BECOMING AWARE OF THE EVENT See SAER form for contact information.Further details are also available in the study team roster.

  • IF THE eCRF IS NOT AVAILABLE THEN THE SAE MUST BE REPORTED ON THE SERIOUS ADVERSE EVENT REPORT (SAER) FORM AND TRANSMITTED TO THE SPONSOR TO MEET THE 24 HOUR TIMELINE REQIREMENT.

  • The investigator will comply with applicable laws/requirements for reporting serious adverse events (SAEs) to the ECs. ALL SAEs ARE TO BE REPORTED ON THE SERIOUS ADVERSE EVENT REPORT (SAER) FORM AND TRANSMITTED TO THE SPONSORWITHIN 24 HOURS AFTER BECOMING AWARE OF THE EVENT See SAER form for contact information.Further details are also available in the study team roster.

  • IF THE ECRF IS NOT AVAILABLE THEN THE SAE MUST BE REPORTED ON THE SERIOUS ADVERSE EVENT REPORT (SAER) FORM ANDTRANSMITTED TO THE SPONSOR TO MEET THE 24 HOUR TIMELINE REQUIREMENT.

  • IF THE eCRF IS NOT AVAILABLE THEN THE SAE MUST BE REPORTED ON THE SERIOUS ADVERSE EVENT REPORT (SAER) FORM ANDTRANSMITTED TO THE SPONSOR TO MEET THE 24 HOUR TIMELINE REQUIREMENT.

  • Serious experiences deemed at least possibly related to use of the investigational drug that are non-fatal and non-life threatening must be reported to the manufacturer’s representative within 24 hours by transmitting a completed SERIOUS ADVERSE EVENT REPORT FORM.

  • A lawyer shall explain a matter to the extent reasonably necessary to permit the client to make informed decisions regarding the representation.Illinois Rule 1.6, in pertinent part, states:(a) ...

  • APPENDICES APPENDIX I: DEMOGRAPHICS APPENDIX II: TREATMENT PLANAPPENDIX III: SERIOUS ADVERSE EVENT REPORT FORM APPENDIX IV: LIST OF CDC QUARANTINE STATIONSAPPENDIX V: PARTICIPANT CONSENT / PARENTAL PERMISSION FORMArtesunate Compassionate Use Participant ID: 🞎🞎🞎🞎🞎 Date Informed Consent form signed (dd/mon/yyyy): / / Determining eligibility:A patient is eligible to receive IV artesunate treatment if at least one criterion is satisfied in EACH of sections A, B, and C.

  • The CROEL monitor is to be notified by the investigator using the SERIOUS ADVERSE EVENT REPORT (SAER) form (within 24 hours of awareness of the event by the investigator.

Related to SERIOUS ADVERSE EVENT REPORT

  • Serious Adverse Event means any adverse event that led to any of the following:

  • Material Adverse Event means an occurrence having a consequence that either (a) is materially adverse as to the business, properties, prospects or financial condition of the Company taken as a whole or (b) is reasonably foreseeable, has a reasonable likelihood of occurring and, if it were to occur, would materially adversely affect the business, properties, prospects or financial condition of the Company taken as a whole.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Company Material Adverse Change means a change (or circumstance involving a prospective change) in the business, operations, assets, liabilities, results of operations, cash flows, condition (financial or otherwise) or prospects of the Company which is materially adverse.

  • Buyer Material Adverse Effect means any material adverse change, event, circumstance or development with respect to, or any material adverse effect on, (a) the business, financial condition or results of operations of the Buyer and its Subsidiaries, taken as a whole, or (b) the ability of the Buyer or the Transitory Subsidiary to consummate the transactions contemplated by this Agreement.

  • Adverse impact on visibility means visibility impairment which interferes with the management, protection, preservation or enjoyment of the visi- tor’s visual experience of the Federal Class I area. This determination must be made on a case-by-case basis taking into account the geographic extent, in- tensity, duration, frequency and time of visibility impairment, and how these factors correlate with (1) times of vis- itor use of the Federal Class I area, and(2) the frequency and timing of natural conditions that reduce visibility.

  • Seller Material Adverse Effect means any event, change or effect that would reasonably be expected to prevent or materially delay the consummation by the applicable Seller of the Contemplated Transactions.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Purchaser Material Adverse Effect means any material and adverse effect on (i) the ability of a Purchaser to meet its obligations under the Basic Documents on a timely basis or (ii) the ability of a Purchaser to consummate the transactions under any Basic Document.

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • Company Material Adverse Effect means a material adverse effect on the assets, business, condition (financial or otherwise), results of operations or future prospects of the Company.

  • Subscriber Material Adverse Effect means an event, change, development, occurrence, condition or effect with respect to Subscriber that would reasonably be expected to have a material adverse effect on Subscriber’s ability to consummate the transactions contemplated hereby, including the purchase of the Subscribed Shares.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Target Material Adverse Effect means any change, effect, event or occurrence that (A) has a material adverse effect on the business, assets, liabilities, financial condition or results of operations of the Target and its subsidiaries taken as a whole or (B) prevents or materially delays the Target from performing its obligations under the Acquisition Agreement in any material respect; provided, however, that no change, effect, event or occurrence to the extent arising or resulting from any of the following, either alone or in combination, shall constitute or be taken into account in determining whether there has been a Target Material Adverse Effect: (i) (A) general economic, financial, political, capital market, credit market, or financial market conditions or (B) general conditions affecting any of the industries in which the Target and its subsidiaries operate; (ii) Changes in Law or changes in GAAP or accounting standards, in either case, occurring after April 26, 2011; (iii) any natural disasters, pandemics or acts of war (whether or not declared), sabotage or terrorism, or an escalation or worsening thereof; (iv) the entry into, announcement or performance of the Acquisition Agreement and the transactions contemplated hereby, including compliance with the covenants set forth herein (other than Section 5.1(a) of the Acquisition Agreement), and the impact thereof on relationships, contractual or otherwise, with customers, suppliers, distributors, partners, employees or regulators, or any shareholder litigation arising from allegations of breach of fiduciary duty relating to the Acquisition Agreement or the transactions contemplated by the Acquisition Agreement, except that this clause (iv) shall not apply with respect to the representations and warranties contained in Section 3.4 of the Acquisition Agreement (v) any changes in the price or trading volume of the Common Stock (as defined in the Acquisition Agreement) (provided that the underlying change, effect, event or occurrence that caused or contributed to such change in market price or trading volume shall not be excluded); (vi) any failure by the Target to meet projections or forecasts (provided that the underlying change, effect, event or occurrence that caused or contributed to such failure to meet projections or forecasts shall not be excluded); and (vii) any change or prospective change in the Target’s credit rating (provided that the underlying change, effect, event or occurrence that caused or contributed to such change or prospective change in the Target’s credit rating shall not be excluded); provided, further, however, that the change, effect, event or occurrence referred to in the preceding clauses (i), (ii) and (iii) shall be excluded pursuant to such clause only to the extent such change, effect, event or occurrence does not adversely affect the Target and its subsidiaries, taken as a whole, disproportionately to other companies operating in the industries in which the Target and its subsidiaries compete (in which case the incremental disproportionate impact or impacts may be taken into account in determining whether there has been, or is reasonably likely to be, a Target Material Adverse Effect).

  • Unreasonable adverse effects on the environment means any unreasonable risk to humans or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.

  • Acquiror Material Adverse Effect means, any change, event, circumstance, occurrence, effect, development or state of facts that, individually or in the aggregate, with any other change, event, circumstance, occurrence, effect, development or state of facts has had or would reasonably be expected to prevent or materially delay or materially impact the ability of Acquiror and the Sponsor to consummate the Transactions. Notwithstanding the foregoing, the amount of the Acquiror Stockholder Redemptions or the failure to obtain the Acquiror Stockholder Approval shall not be deemed to be an Acquiror Material Adverse Effect.

  • Final Adverse Benefit Determination means an adverse benefit determination that is upheld at the completion of a health plan issuer’s internal appeals process.

  • Adverse impact means any deleterious effect on waters or wetlands, including their quality, quantity, surface area, species composition, aesthetics or usefulness for human or natural uses which are or may potentially be harmful or injurious to human health, welfare, safety or property, to biological productivity, diversity, or stability or which unreasonably interfere with the enjoyment of life or property, including outdoor recreation.

  • Investor Material Adverse Effect means, with respect to a particular Investor, any fact, event, circumstance, change, occurrence, effect or condition which has had or would reasonably be expected to have, individually or in the aggregate with all other facts, events, circumstances, changes, occurrences, effects or conditions, a material adverse effect on the ability of such Investor to consummate the transactions contemplated by this Agreement.

  • Property Material Adverse Effect shall have the meaning assigned thereto in the Mortgage.

  • Deemed Material and Adverse Representation Each representation and warranty identified as such in Section 9.02 of this Agreement.

  • Partnership Material Adverse Effect means any change, circumstance, effect or condition that is, or could reasonably be expected to be, materially adverse to the business, financial condition, assets, liabilities or results of operations of the Partnership Group, taken as a whole.

  • SPAC Material Adverse Effect means any Effect that, individually or in the aggregate with all other Effects, is or would reasonably be expected to (a) have a material adverse effect on the business, condition (financial or otherwise), assets, liabilities or operations of the SPAC; or (b) prevent, materially delay or materially impede the performance by the SPAC or Merger Sub of their respective obligations under this Agreement or the consummation of the Merger or any of the other Transactions; provided, however, that none of the following shall be deemed to constitute, alone or in combination, or be taken into account in the determination of whether, there has been or will be a SPAC Material Adverse Effect: (i) any change or proposed change in or change in the interpretation of any Law (including any COVID-19 Measures) or GAAP; (ii) events or conditions generally affecting the industries or geographic areas in which the SPAC operates; (iii) any downturn in general economic conditions, including changes in the credit, debt, securities, financial or capital markets (including changes in interest or exchange rates, prices of any security or market index or commodity or any disruption of such markets); (iv) acts of war, sabotage, civil unrest, terrorism, epidemics, pandemics or disease outbreaks (including COVID-19) or any escalation or worsening of any such acts of war, sabotage, civil unrest, terrorism, epidemics, pandemics or disease outbreaks, or changes in global, national, regional, state or local political or social conditions; (v) any hurricane, tornado, flood, earthquake, natural disaster, or other acts of God; (vi) any actions taken or not taken by the SPAC as required by this Agreement or any Ancillary Agreement; (vii) any Effect attributable to the announcement or execution, pendency, negotiation or consummation of the Merger or any of the other Transactions (including any redemptions by any stockholders of the SPAC); or (viii) any actions or failures to take action, in each case, which the Company has requested or to which it has consented or which actions are contemplated by this Agreement, except in the cases of the foregoing clauses (i) through (iii), to the extent that the SPAC is materially and disproportionately affected thereby as compared with other participants in the industries in which the SPAC operates.

  • Incident Report means a written report of any injury, accident, acts of physical aggression, or unusual incident involving an individual.

  • Serious Record means a conviction or any finding of guilt regarding a Serious Offence; and Vulnerable Person means an individual aged 18 years and above who is or may be unable to take care of themselves, or is unable to protect themselves against harm or exploitation for any reason, including age, physical or mental illness, trauma or disability, pregnancy, the influence, or past or existing use, of alcohol, drugs or substances or any other reason.