Get Local Adverse Event Report - Ouhsc

This guide provides clear and supportive instructions on how to complete the LOCAL ADVERSE EVENT REPORT form online. Understanding the importance of accurately reporting adverse events is crucial for the safety and integrity of research studies.

Follow the steps to complete your report effectively.

1. Press the ‘Get Form’ button to obtain the document and open it for editing.
2. Fill out SECTION I: INFORMATION. Provide the Protocol IRB number, Investigator's name, and Protocol Title. Complete participant information including Identifier, Age, Gender, and important dates regarding the adverse event and study participation.
3. In SECTION II: DESCRIPTION, summarize the adverse event in one sentence. Then, provide a detailed description that includes the medical nature of the adverse event, relevant medical history, and other treatments the participant has undergone.
4. Answer the question regarding long-term consequences anticipated by the Investigator by selecting 'Yes' or 'No.'
5. Assess the relationship between the adverse event and the study participation in D. Complete all related questions, indicating if the adverse event was anticipated or unanticipated.
6. If applicable, move to SECTION III: ACTION. Indicate whether the adverse event requires a change to the research protocol or closure of the study.
7. Review if the risk associated with the adverse event is included in the informed consent/assent forms. If not, decide if modifications are needed.
8. Confirm compliance with reporting requirements for relevant agencies, filling out the necessary details regarding whom the event was reported to and when.
9. Finally, ensure the Investigator's signature and date are included at the end of the report.
10. After completing the form, you can save changes, download, print, or share your document securely.

Take proactive steps to ensure the safety of your study participants by completing and submitting the LOCAL ADVERSE EVENT REPORT online today.