Adverse Event (AE) Clause Samples

The Adverse Event (AE) clause defines what constitutes an adverse event within the context of the agreement, typically referring to any undesirable experience or medical occurrence associated with the use of a product or participation in a study. This clause outlines the types of events that must be reported, the procedures for reporting them, and the responsibilities of each party in documenting and responding to such events. Its core practical function is to ensure prompt identification and management of safety issues, thereby protecting participants and complying with regulatory requirements.
Adverse Event (AE). Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Therefore an AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal products, whether or not considered related to the medicinal product. A valid report of an adverse event must contain the following minimum information: • patient identification i.e. one or more of the following: initials; identification number such as clinical trial number; age or date of birth; gender • an identifiable source (reporter’s name or initials and/or address and/or qualifications e.g. physician, dentist, pharmacist, nurse) • suspected drug(s) • a specific adverse event
View Source
Adverse Event (AE). An adverse event is defined as any untoward medical occurrence experienced by or worsening of a pre-existing condition of a subject during this trial in relation to the investigational device or study procedure. The assessment whether a detected adverse event is related to the investigational product or procedure is done by the specific site investigator. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device. This definition includes events that are anticipated as well as unanticipated events, and also includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
View Source
Adverse Event (AE). An AE is any untoward medical occurrence in a patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable 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. This includes the following: an AE occurring in the course of the use of a drug product in professional practice; an AE occurring from drug overdose whether accidental or intentional; an AE occurring from drug abuse; an AE occurring from drug withdrawal; and any failure of expected pharmacological action.
View Source
Adverse Event (AE). An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug-related. This includes an exacerbation of a pre-existing condition. AEs include: • Worsening (change in nature, severity, or frequency) of conditions present at the onset of the study • Intercurrent illnesses • Drug interactions • Events related to or possibly related to concomitant medications • Abnormal laboratory values (this includes significant shifts from baseline within the range of normal that the Investigator considers to be clinically important) • Clinically significant abnormalities in PE, ▇▇▇▇▇ ▇▇▇▇▇, and weight Note that PD should not be reported as an AE unless it is considered to be drug-related by the Investigator. All AEs, including AEs attributed to study procedures, occurring from the time of study informed consent until 30 days after last study treatment must be reported on the AE eCRF, regardless of the severity or relationship to study drug. Only AEs which are considered related to a study procedure (ie blood draw or fresh tumor biopsy) will be captured during the pre- screening period, ie from the time of signing the pre-screening consent (if one is utilized) until the signing of the main study informed consent, or until the patient is determined to be a screen failure. The Investigator should treat patients with AEs appropriately and observe them at suitable intervals until the events stabilize, return to baseline or resolve. AEs may be discovered through observation or examination of the patient, questioning of the patient, complaint by the patient, or by abnormal clinical laboratory values. In addition, AEs may also include laboratory values that become significantly out of range. Such abnormal laboratory values or test results constitute AEs if they induce clinical signs or symptoms, are considered clinically significant (eg, cause study drug discontinuation or constitutes in and of itself an SAE, or require therapy, and should be recorded on the AE eCRF under the signs, symptoms or diagnosis associated with them. In the event of an out-of-range value, the laboratory test should be repeated until it returns to normal or baseline or can be explained and the patient’s safety is not at risk.
View Source
Adverse Event (AE). An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. Worsening of a pre-treatment event, after initiation of tazemetostat, must be recorded as a new AE. For example, if a subject experiences mild intermittent dyspepsia prior to dosing tazemetostat, but the dyspepsia becomes severe and more frequent after the first dose of tazemetostat, a new AE of severe worsening dyspepsia (with the appropriate date of onset) should be recorded in the eCRF. “Lack of efficacy” or “failure of an expected pharmacological action” per se is not to be reported as an AE or SAE. However, any signs and symptoms and/or clinical sequelae resulting from “lack of efficacy” will be reported as an AE or SAE, if they fulfill the definition of an AE or SAE. Events that do not meet the definition of an AE include: • Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to the procedure is an AE. • Situations where an untoward medical occurrence did not occur (social and/or convenience admission to a hospital). • Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen.
View Source
Adverse Event (AE). Monitoring
View Source

Related to Adverse Event (AE)

  • 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.

  • 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.

  • 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.

  • Product Complaints Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;

  • Regulatory Investigations TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.