2. Safety Reporting Incident Reports Serious Adverse Events (SAE)

3. What is an Incident Report? It is an event that occurs but that is not life threatening. Reportable events could be: an inadvertent breech of confidentiality, threats of suicide, homicide, reports of abuse, etc. You should have processes in place for reporting these types of events at your local area and we encourage you to review them.

4. What is a Serious Adverse Event? It is anything happening to the participant that is life threatening, irregardless of whether it is related to the project, that deals with death, trips to the hospital, etc.

5. Abuse A participant comes into the clinic/grantee office and tells you that they are being abused by their spouse. What do you do?

6. Inadvertent Breech of Confidentiality Some examples could include: project staff discussing participant information in the lunch room, family/relatives who work with the project openly discussing participants information with family, and community advisors being exposed to confidential information during their meetings with project staff.

7. Adverse Reaction to Exercise Some examples could be: Participants could possibly experience exercise induced asthma, sprained muscles/ankles, possible broken bones due to general environmental safety issues like weather, animals, exercise equipment, etc. How would you report this?

8. Steps in Submitting a Safety Report to the CC Submit either the SAE or Incident Report Form to your local or Area IRB, you will need to review their policy. If reporting is not required, follow the next two steps. Fax a copy of either the SAE or Incident Report Form to the Coordinating Center Data Coordinator within 15 days of it’s occurrence. Make a copy/keep the original and file it under Safety Reports in the participants file.

9. Review of Forms Incident Report Form Serious Adverse Events (SAE) Report Form (Appendix T)