preview

Unanticipatet Study

Better Essays

6.1. Off Study Criteria • All protocol interventions are complete • Death • Request of the Patient/Parent • Discretion of the Study PI 7.0 SAFETY AND ADVERSE EVENT REPORTING REQUIREMENTS 7.1. Reporting Adverse Experiences and Deaths to St. Jude IRB Only “unanticipated problems involving risks to participants or others” referred to hereafter as “unanticipated problems” are required to be reported to the St. Jude IRB promptly, but in no event later than 10 working days after the investigator first learns of the unanticipated problem. Regardless of whether the event is internal or external (for example, an IND safety report by the sponsor pursuant to 21 CFR 312.32), only adverse events that constitute unanticipated problems are reportable …show more content…

Unexpected Adverse Event: • Any adverse event for which the specificity or severity is not consistent with the protocol-related documents, including the applicable investigator brochure, IRB approved consent form, Investigational New Drug (IND) or Investigational

Get Access