Serious Adverse Events. All serious adverse events, regardless of causality, will be reported in writing and according to Study procedures and the Protocol by the Investigator to MedImmune and/or its designated representatives within twenty-four (24) hours after the Investigator or the relevant sub investigator has become aware of the serious adverse event. Serious adverse events will also be reported to the relevant ethics committee as per the Regulations and relevant ethics committee requirements. Institution and Investigator will provide assistance to MedImmune and/or its designated representatives as requested to clarify the facts and circumstances of each reported serious adverse event. CRO shall report any adverse events to the regulatory authorities and will prepare and submit the annual safety report to the appropriate regulatory authorities. 1.5
Serious Adverse Events. In addition to reporting all AEs (serious and non-serious) meeting the definitions, the Investigator must report any occurrence of the following as an SAE: An ocular infection including a presumed infectious ulcer with any of the following characteristics: o Central or paracentral location o Penetration of Xxxxxx’x membrane o Infiltrates > 2 mm diameter o Iritis o Increase in intraocular pressure o Culture positive for microorganisms o Increasing size or severity at subsequent visits Any central or paracentral corneal event (such as neovascularization) that results in permanent opacification Hypopyon Hyphema Neovascularization within the central 6 mm of the cornea Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve Uveitis (anterior, intermediate, or posterior) Corneal abrasion affecting ≥ 50% of corneal surface area
Serious Adverse Events. The Physician shall immediately communicate the occurrence of serious adverse events as defined in the Protocol (each, an “SAE”) to Biogen Idec as directed in the Protocol. If it becomes necessary to report an SAE to the competent authorities, the author of the report consents to the related disclosure of his or her personal information. 1.7 Závažné nežádoucí příhody Xxxxx xx povinen společnost Biogen Idec neprodleně informovat o výskytu závažných nežádoucích příhod, jak jsou definovány v protokolu (xxxx označovány jako „SAE“), postupem uvedeným v protokolu. Pokud je nezbytné nahlásit SAE příslušným orgánům, autor hlášení souhlasí se souvisejícím předáním svých osobních údajů.
Serious Adverse Events. To the best of Rigel’s knowledge, there have been no Serious Adverse Events relating to the Compounds, except for those disclosed to AZ as part of the formal due diligence process between Rigel and AZ prior to the Execution Date.
Serious Adverse Events. An adverse event is considered serious if it meets the definition of a serious adverse event (SAE) as defined in Section 21.2. Serious adverse events may occur at any time during the study and will be reported as serious regardless of when they occur, provided they meet the definition of a serious adverse event.
Serious Adverse Events. Serious adverse events that occur at the local institution (Institution B) must be reported to the Institution B’s local IRB as per local institutional policy and should not be reported to Institution A’s IRB.
Serious Adverse Events. A serious adverse event is (SAE) defined as any untoward medical occurrence that at any dose results in one of the following outcomes: • Death • A life-threatening adverse drug experience • Results in inpatient hospitalization or prolongation of existing hospitalization • A persistent or significant disability/incapacity • A congenital anomaly/birth defect Important medical events that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug event when, based upon appropriate medical judgment, they may jeopardize the patient 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 convulsion that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. If an event is documented as serious, then a separate SAE Report form must completed. For studies under a Food and Drug Administration (FDA) Investigational New Drug (IND) application, a 3500A is completed and submitted as an expedited report, if the event is also unexpected and related to the study intervention. Because the data collected for an SAE are descriptive and beyond the scope of a study, the SAE information is usually kept in a separate file. In addition to the SAE descriptors, it is useful to track when the SAE is sent to the IRB, sponsor, FDA, and DSMB and responses received. In some neurological studies, there has been confusion over the relationship between a study endpoint (e.g. myocardial infarc tion) and an SAE. The AE may be heart attack, described as mild. However, since it resulted in a hospitalization, it is coded as “serious” (SAE). The event may also be a study endpoint that is captured on the SAE form and sent for adjudication. This process would be tracked but the information collected is generally beyond the study scope and is not captured on study case report forms nor entered into the study data management system.
Serious Adverse Events. All SAEs will be reported immediately, within 24 hours of discovery or notification of the event, by the clinical study site to VIVUS, or its designee, according to SOPs specified by VIVUS. VIVUS will be responsible for submitting all immediately reportable SAEs (serious, causally related and unexpected) to the Food and Drug Administration (FDA) in accordance with the current regulations. If a SAE has occurred at a site, the Medpace CRA will always 100% source document verify the event during the monitoring visit to ensure it has been recorded, documented, and reported appropriately and accurately. In addition, data queries will be resolved during the visits, CRF changes will be verified, and supporting documentation for SAEs will be obtained. Medpace will provide VIVUS listings of non-serious adverse events from all sites to support filing of the Annual Safety Reports. Medpace will reconcile SAE listings with the AE database. DATA MANAGEMENT Data Management activities performed by Medpace will include eCRF tracking, preparation of a data management manual, eCRF review, coding of adverse events and concomitant medications, medical histories, data cleaning/editing, querying, query *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. tracking, final database quality review, and delivery of the final SAS® database. The data cleaning process will be performed on an ongoing basis following Medpace Data Management SOPs. Two data transfers (SAS transport files) will be performed: a test transfer prior to FPFV and a final transfer. A unit price for additional data transfers has been provided in the budget.
Serious Adverse Events. As defined in the Code of Federal Regulations (21 CFR 312.32), a serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: · Results in death; · Is life-threatening (immediate risk of death); · Requires inpatient hospitalization or prolongation of existing hospitalization; *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. · Results in persistent or significant disability/incapacity; · Results in congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious adverse drug experiences when, based on appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above. Adverse events that, in the investigator’s judgment, significantly jeopardize trial subjects or require medical or surgical intervention in order to prevent any of the outcomes listed above should therefore be reported as serious adverse events.
Serious Adverse Events. A serious adverse event (SAE) is any untoward medical occurrence that: • results in death (note: death is an outcome, not an event); • is life-threatening; (note: the term "life-threatening" refers to an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event which could hypothetically have caused a death had it been more severe); • requires in-patient hospitalization or prolongs an existing hospitalization; • results in persistent or significant disability/incapacity; • is a congenital anomaly/birth defect; • is medically significant or requires intervention to prevent one or other of the outcomes listed above (note: examples are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization). SAEs are to be reported to NovImmune immediately. The term severe is a measure of intensity/severity: thus a severe adverse event is not necessarily serious. For example, nausea of several hours’ duration may be rated as severe, but may not be clinically serious. For the purposes of this study, the following will not be considered as serious adverse events: • Elective hospitalizations or surgical procedures that are a result of a patient’s pre-existing condition(s) which have not worsened since receiving IMP. Such events should still be recorded as adverse events in the eCRF; • Hospitalization as requested per protocol for NI-0501infusion and study visits. Any serious clinical adverse event or clinically significant abnormal laboratory test value that occurs during the course of the study, irrespective of the treatment received by the subject, must be communicated by the Investigator to NovImmune, by fax or electronic transmission, within 24 hours of awareness. For the initial SAE report, the Investigator should report all available case details concerning the patient and the event, using the NovImmune SAE reporting standard form (see Appendix F). NovImmune contact information for SAE reporting: Relevant follow-up information on SAEs should be forwarded to NovImmune as soon as it becomes available. In addition, the Investigator must be available to answer without delay any request for follow- up information or questions NovImmune may have regarding the SAE. All SAEs will be recorded on the appropriate page of the eCRF. They will be reviewed, evaluated and followed through to resolution by a study physician- Relationship to t...
