Time Period and Frequency for Collecting AE and SAE Information Sample Clauses

Time Period and Frequency for Collecting AE and SAE Information. AEs and SAEs will be collected from consent until the follow-up visit (4 weeks from last dose of study treatment). All medical occurrences, with the exception of SAEs, that begin after obtaining ICF and before the first dose of study treatment will be recorded on the Medical History/Current Medical Conditions section of the eCRF and not the AE section. All SAEs will be recorded and reported to the Sponsor or designee immediately upon the site learning of an event, and under no circumstance should the initial notification exceed 24 hours, as indicated in Appendix 3 (Section 10.3). The investigator will submit any updated SAE data to the Sponsor or designee within 24 hours of it being available. Investigators are not obligated to actively seek AEs or SAEs that start after conclusion of study participation. However, if the investigator learns of any SAE, including a death, at any time after a subject has been withdrawn from the study, and he/she considers the event to be reasonably related to the study treatment or study participation, the investigator must promptly notify the Sponsor.
Sample 1
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