Procedures for Recording and Reporting AEs and SAEs Sample Clauses

Procedures for Recording and Reporting AEs and SAEs. All adverse events spontaneously reported by the subject and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures must be recorded in the source document and on the appropriate page of the case report form. Any clinically relevant deterioration in laboratory assessments or other clinical findings is considered an adverse event and must be recorded on the appropriate pages of the case report form. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. All SAEs that occur during the course of the study, as defined by the protocol, must be reported by the Investigator to the Study Safety Officer by completing and transmitting the SAE Form within one working day from the point in time when the Investigator becomes aware of the SAE. In addition, all SAEs including all deaths, which occur up to and including 30 days after administration of the last dose of study drug, must be reported to the Study Safety Officer within one working day. All SAEs and deaths must be reported whether or not considered causally related to the study drug. SAE forms will be provided to the study site. The information collected will include a minimum of the following: subject number, a narrative description of the event, and an assessment by the Investigator as to the intensity of the event, and relatedness to study drug. Follow-up information on the SAE may be requested by the CRO, the Study Safety Officer or the Sponsor Medical Monitor. Contact information for reporting SAEs to the Study Safety Officer is provided on the SAE form. Study Safety Officer Contact Information PLEASE SEE SERIOUS ADVERSE EVENT REPORTING FORM FOR DETAILED REPORTING OF SAEs, INCLUDING CONTACT INFORMATION (e.g., FAX, EMAIL OR TELEPHONE CONTACT NUMBERS) It is the responsibility of the Investigator to promptly notify the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of all serious adverse drug reactions involving risk to human subjects in accordance with the requirements of the IRB/IEC. An unexpected event is one that is not reported in the Investigator’s Brochure. Planned hospital admissions or surgical procedures for an illness or disease that existed before the subject was enrolled in the trial or before study drug was given are not to be considered AEs unless they occur at a time other than the planned date. Fractures identified during the stu...
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