Serious means violations that either result in one or more neg- ative outcomes and significant actual harm to residents that does not constitute imminent danger, or there is a reasonable predictability of recurring actions, practices, situations, or incidents with potential for causing significant harm to a resident, or both.
Serious means violations that result in one or more negative outcomes and significant actual harm to residents that does not con stitute imminent danger; and/or, there is reasonable predictability of recurring actions, practices, situations or incidents with potential for causing significant harm to a resident.
Serious means violations that result in one or more negative outcomes and significant actual harm to residents that does not constitute imminent danger; and/or, there is rea- sonable predictability of recurring actions, practices, situa- tions or incidents with potential for causing significant harm to a resident.
More Definitions of Serious
Serious adverse events shall be reported to the other Party within three (3) working days of a Party's becoming aware of such an event (a "reporting party") and shall either be reported by facsimile or telephone. The reporting party shall report all other adverse events on a monthly basis. In addition, the reporting party shall report all known instances of use of a Licensed Product during pregnancy. Attached as Exhibit D is a sample of an adverse event reporting form which may be used by the reporting party as a basis for such reports. The form indicates the information sought with each report. In any event, each Party shall promptly notify the other of any complaint received by such Party in sufficient detail and in sufficient time to allow the responsible party to comply with any and all regulatory requirements imposed upon it in any country in their respective territories. Each Party shall also advise the other of any regulatory developments (e.g., proposed recalls, labeling and other registrational dossier changes, etc.) affecting the Compounds or the Licensed Products in any country.
Serious means a violation that results in one or more negative outcomes and significant actual harm to a client that does not consti tute imminent danger. It also means there is reasonable predictability of recurring actions, practices, situations or incidents with poten tial for causing significant harm to a client.
Serious as defined in the SARA means that the ideation is experienced as persistent and intrusive or involves high lethality methods; or that the level of intent is moderate to high.
Serious means dangerous to life or property;
Serious means an experience or reaction which is fatal or life threatening, results in persistent or significant disability, requires inpatient hospitalization or prolongation of existing inpatient hospitalization, is a congenital anomaly, cancer, or the result of an overdose, or is another important medical event (even if not life-threatening, resulting in death, or requiring hospitalization) if, based upon appropriate medical judgments, such medical event may jeopardize the patient’s or subject’s health or may require medical or surgical intervention to prevent one of the other outcomes listed previously, and (B) “unexpected” means a condition or development not listed in the then-current FDA-approved labeling for the Product, and includes those experiences or reactions that show a significant increase in incidence or severity over what appears on the labeling of the Product or in NDA trials or that are a failure of the Product to achieve claimed activity.
Serious as used in this Section 11.1 refers to an experience which results in death, permanent or substantial disability, in-patient hospitalization, prolongation of existing in-patient hospitalization, a congenital anomaly or cancer, or a result of an overdose or life threatening condition. “Unexpected” as used in this Section 11.1 refers to (i) conditions or developments not previously submitted to governmental Agencies or encountered during clinical studies of the Products and not reflected in the Product Promotional Materials or the Product Labeling, or (ii) conditions or developments occurring with greater frequency, severity, or specificity than shown by information previously submitted to governmental Agencies or encountered during clinical studies of the Products and not reflected in the Product Promotional Materials or the Product Labeling. Each party shall also notify the other in a timely manner of any other adverse experience, i.e., any unfavorable and unintended change in the structure (signs), function (symptoms) or chemistry (laboratory data) of the body temporally associated with the use of the Products, whether or not considered related thereto.
Serious means an experience which (a) results in the death, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, in-patient hospitalization or prolongation of hospitalization, or (b) is a congenital anomaly, the result of an overdose or life threatening (only if unrelated to primary disease); and “unexpected” shall mean (x) for a nonmarketed Product, an experience that is not identified in nature, severity or frequency in the current clinical investigator’s confidential information brochure, and (y) for a marketed product, an event which is not listed in the current labeling for such product, and includes an event that may be symptomatically and pathophysiologically related to an experience listed in the labeling but differs from the event because of increased frequency or greater severity or specificity. Each party further shall immediately notify the other party of any information received regarding any threatened or pending action by an agency that may affect the safety and efficacy claims of the Product. Upon receipt of any such information, the parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall restrict either party’s right to make a timely report of such matter to any government agency or take other action that it deems to be appropriate or required by applicable law, regulation or court order. Each party shall take all reasonable steps to protect the confidentiality of any patient health and medical information that it has access to and to comply with applicable state and federal privacy laws, as such laws apply to such party.