Recording of Adverse Events Sample Clauses

Recording of Adverse Events. Any AE should be recorded on the Adverse Events form in the CRF and source documents. In order to avoid vague, ambiguous or colloquial expressions, the AE should be recorded in standard medical terminology rather than the subject’s own words. Whenever possible, the Investigator should group together into a single term signs and symptoms which constitute a single diagnosis. The existence of or change in an AE may be concluded due to the necessity to administer a concomitant medication, from a spontaneous report of the subject, from the physical examination or from special tests like ECG, EEGs, laboratory assessments or other study specified tests (source of AE). For each subject that has signed the informed consent and prior to study drug allocation at any dose, any change to medical status should be recorded in patient’s medical file in accordance to local requirements and the medical history CRF only. Any change to medical status, which occurs after study drug allocation at any dose in the specified study AE collection period will be handled as an (S)AE. For each subject that has signed the informed consent but does not qualify for allocation to treatment, i.e. Screen Failure, any change to medical status (from the time of ICF signature until determination of non-qualification for the study) should be recorded in patient’s medical file according to local requirements. The related medical status change information will not be reviewed by Xxxxxx or delegated staff, and will not qualify as a study (S)AE. Each AE, of the treatment arm, is to be evaluated for duration, severity, seriousness and causal relationship to the investigational drug. The action taken with study drug, the concomitant treatment/therapy introduced and the outcome as well as whether the event led to study termination will also be recorded. The post-study AE collection period is defined as 30 days after the subject’s safety follow-up call (collection of (S)AEs should be passive in this period unless otherwise specified).
Sample 1
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Recording of Adverse Events. AE will be reported and recorded in the eCRF from the time of the first dose of study treatment through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. That is, if a patient begins a new antineoplastic therapy, the AE reporting period for nonserious AEs ends at the time the new treatment is started. Adverse events (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible, rather than individual underlying signs and symptoms. When a clear diagnosis cannot be identified, each sign or symptom should be recorded as a separate AE. The Investigator should ask the patient non-leading questions to determine if any AEs have occurred during the study, since the last study visit. Adverse events may also be recorded when they are volunteered by the patient, or through physical examination, laboratory tests, or other clinical assessments. An AE should be followed until its resolution or until it is judged to be permanent, and assessment should be made at each 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. All AEs occurring during the study are to be followed up in accordance with good medical practice until they are resolved, stabilized or judged no longer clinically significant or, if a chronic condition, until fully characterized.
Sample 1
Recording of Adverse Events. Adverse Events are illnesses or signs/symptoms that appear or worsen during the testing of a drug whether or not considered related to the investigational product (synonyms = medicinal or pharmaceutical product, study drug, clinical trial materials, etc.), including side effects, injury, toxicity, or hypersensitivity reactions. All adverse events, including observed, elicited, or volunteered problems, complaints or symptoms, are to be recorded on the Adverse Events page in the subject’s Case Report Form. The need to capture this information is not dependent upon whether adverse events are associated with use of the investigational product. Adverse events resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications progression of disease states should also be recorded. In order to avoid vague, ambiguous or colloquial expressions, adverse events should be recorded in standard medical terminology rather than the subject's own words. Signs and symptoms should be reported individually unless, in the judgment of the investigator, they can be grouped under an inclusive term (e.g., gastroenteritis in lieu of abdominal pain, nausea, vomiting, and diarrhea). Each adverse event is to be evaluated for date/time of onset, duration, intensity, and causal relationship with the investigational product or other factors. At every study visit, the investigator must document new AEs and the outcome of ongoing AEs. Any subject with an AE (including SAEs) or any clinically significant abnormal laboratory result or physical finding reported as an AE will be followed by the investigator until the AE resolves, resolves with sequalae, is otherwise explained by a medical condition, follow-up is not possible (document), or the subject dies.
Sample 1
Recording of Adverse Events. ‌ All AEs that begin or worsen after the patient has provided informed consent will be recorded. Those AEs that occur prior to study dosing, can be captured in the patient’s baseline conditions, however if any of these AEs are considered, serious, these are to be reported both to Pharmacovigilance and documented in the eCRF AE log. For events that are considered by the Investigator to be related to the study drug, the monitoring of the AE should be continued through the end of the study, for at least 30 days following last dose of study drug (if the end of the study is within 30 days of the last dose of study drug), or until the AE has resolved. Investigators should use medical judgment in determining whether a particular symptom or sign is considered to be a part of COVID-19 infection clinical course or not and report them or not as AEs according to such determination. When a clear determination cannot be made by the investigators, a sign or symptom should be reported as AEs. All deaths irrespective of cause of death including due to COVID-19 during the study should be reported to the Sponsor using an SAE form. Adverse events (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible, rather than individual underlying signs and symptoms. When a clear diagnosis cannot be identified, each sign or symptom should be recorded as a separate AE. The Investigator should ask the patient non-leading questions to determine if any AEs have occurred during the study, since the last study visit. Adverse events may also be recorded when they are volunteered by the patient, or through physical examination, laboratory tests, or other clinical assessments. An AE should be followed until its resolution or until it is judged to be permanent, and assessment should be made at each 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.
Sample 1

Related to Recording of Adverse Events

  • 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.

  • Notice of Adverse Change Recipient shall promptly notify OBDD of any adverse change in the activities, prospects or condition (financial or otherwise) of Recipient or the Project related to the ability of Recipient to perform all obligations required by this Contract.

  • 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 Adverse Changes Since the date of the Company Balance Sheet until the date of this Agreement, there has not occurred any change, event, circumstance or development that is reasonably likely to have a Company Material Adverse Effect. From the date of the Company Balance Sheet until the date of this Agreement, except as contemplated hereby or as set forth in Section 3.8 of the Company Disclosure Schedule, (a) the business of the Company and the Company Subsidiaries, taken as a whole, has been conducted in the ordinary course of business and (b) none of the Company or any Company Subsidiary has taken any action that would have required the consent of Parent under Section 5.1(b) of this Agreement, had such action or event occurred after the date of this Agreement.

  • Notice of Adverse Claims Except for the claims and interests of the Secured Party and the Lien Grantor in the Securities, the Issuer does not know of any claim to, or interest in, the Securities. If any person asserts any lien, encumbrance or adverse claim (including any writ, garnishment, judgment, attachment, execution or similar process) against the Securities, the Issuer will promptly notify the Secured Party and the Lien Grantor thereof.

  • Notice of Material Adverse Effect The Company shall notify the Buyer (and any subsequent holder of the Debentures), as soon as practicable and in no event later than three (3) business days of the Company’s knowledge of any Material Adverse Effect on the Company. For purposes of the foregoing, “knowledge” means the earlier of the Company’s actual knowledge or the Company’s constructive knowledge upon due inquiry.

  • Determination of Adverse Consequences The Parties shall take into account the time cost of money (using the Applicable Rate as the discount rate) in determining Adverse Consequences for purposes of this Section 8. All indemnification payments under this Section 8 shall be deemed adjustments to the Purchase Price.

  • 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.

  • Filing of Materials All records related to a grievance shall be filed separately from the personnel files of the employees.

  • Notice of Default, Litigation and Material Adverse Effect Promptly, and in any event within three Business Days after any officer of the Borrower or any of its Subsidiaries obtains knowledge thereof, notice of (i) the occurrence of any event which constitutes a Default or an Event of Default, (ii) any litigation or governmental investigation or proceeding pending against the Borrower or any of its Subsidiaries (x) which, either individually or in the aggregate, could reasonably be expected to have a Material Adverse Effect or (y) with respect to any Document, or (iii) any other event, change or circumstance that has had, or could reasonably be expected to have, a Material Adverse Effect.

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