Common use of SAE and SUSAR Reporting Clause in Contracts

SAE and SUSAR Reporting. To ensure patient safety, every SAE and SUSAR, regardless of suspected causality, occurring during the adverse event reporting period must be reported to the Sponsor within 24 hours of learning of its occurrence. Recurrent episodes, complications, or progression of the initial SAE must be reported as follow-up information is received. An SAE occurring at a different time interval or otherwise considered completely unrelated to a previously reported one should be reported separately as a new event.

SAE and SUSAR Reporting. To ensure patient safety, every SAE and SUSAR, regardless of suspected causality, occurring during the adverse event reporting period defined in Section 5.2.1 must be reported to the Sponsor within 24 hours of learning of its occurrence. Recurrent episodes, complications, or progression of the initial SAE must be reported as follow-up information is received. An SAE occurring at a different time interval or otherwise considered completely unrelated to a previously reported one should be reported separately as a new event.