Follow-up of AEs and SAEs Sample Clauses

Follow-up of AEs and SAEs. After the initial AE/SAE report, the investigator is required to proactively follow each subject at subsequent visits/contacts. All SAEs will be followed until resolution, stabilization, the event is otherwise explained, or the subject is lost to follow-up (as defined in Section 7.2). Further information on follow-up procedures is given in Appendix 3 (Section 10.3).
Sample 1
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Follow-up of AEs and SAEs. All AEs and SAEs must be followed until resolution, until the condition stabilises, until the event is otherwise explained, or the subject is lost to follow-up. The investigator is responsible to ensure that follow-up includes any supplemental investigations as may be indicated to elucidate as completely as practical the nature and/or causality of the AE or SAE. This may include additional laboratory tests or investigations, histopathological examinations, or consultation with other health care professionals. GW may request that the investigator perform or arrange for the conduct of supplemental measurements and/or evaluations. If a subject dies during participation in the study or during a recognised follow-up period, GW should be provided with a copy of any post-mortem findings, including histopathology. New or updated information should be recorded on the originally completed SAE CRF with all changes signed and dated by the investigator.
Sample 1
Follow-up of AEs and SAEs. All AEs must be followed during the course of the study until the AE resolves, is no longer of clinical concern, has stabilized or is otherwise explained, or the patient is lost to follow-up. AEs ongoing at the final visit or assessment that are deemed to be “related” to the investigational product or of other clinical significance, must be followed for as long as necessary to adequately evaluate the safety of the patient or until the event stabilizes, resolves, or is no longer of clinical concern. If resolved, a resolution date for the AE should be documented in the CRF. The Investigator must ensure that follow-up includes any supplemental investigations indicated to elucidate the nature and/or causality of the AE. This may include additional laboratory tests or investigations, or consultation with other healthcare professionals, as considered clinically appropriate by the Investigator.
Sample 1

Related to Follow-up of AEs and SAEs

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