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.
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.
Serious Adverse Events. In addition to reporting all AEs (serious and nonserious) 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. 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; · 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 jeopardized trial subjects or required 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. 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. 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. 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 (SAEs) experienced in the course of the study need to be evaluated without delay in the interest of the study patients. Therefore, the Investigator must notify such events immediately to the responsible representative of the CRO and to the Sponsor’s Drug Safety Officer. Further procedures, the definition of SAE, details on notification, including communication data are specified in the study protocol. 9.
Serious Adverse Events. Sponsor agrees to pay Payee for actual costs incurred in the processing and reporting of SAEs that occur in connection with the Study, up to the limit defined in the Budget per SAE event. Payments will be made within forty-five (45) days of receipt of an undisputed itemized invoice as defined in Attachment B-1. I.
Serious Adverse Events. See Section 8.1 for the definition of an SAE. Please note that SAEs that occur at any time between the signing of the Informed Consent Form up to the first dose of study treatment must be reported (in addition to SAEs that occur after the first dose of study treatment).
8.2.1.1. Events that Do Not Meet the Definition of a Serious Adverse Event
