Status of Participants Indicate if the participant(s) is/are still involved in the study. Still in the Study No Longer in the Study Not Applicable Status of Research Recruitment Indicate if participants are still being recruited into this study. Ongoing Completed (or Stopped) Not Applicable Status of Interventions/Interactions Indicate if participants are still being recruited into this study. Ongoing Completed (or Stopped) Not Applicable Impact on Participants Indicate if the event resulted in a violation of the participant’s rights, safety, or welfare. Yes No If Yes, explain how the event resulted in a violation of the participant's rights, safety, or welfare: Other Reporting Indicate where else you will be reporting this event to (check all that apply). Sponsor of Study Food and Drug Administration (FDA) Collaborating Investigators Data Safety Monitoring Board Not Applicable Other: Actions to Take As a result of the event, indicate the corrections/changes that you will be taking (if applicable) to resolve the current issue and/or prevent similar events from occurring in the future (check all that apply): Modification to Protocol/Study Procedures Modification to Level of Risk Modification to Consent Form Provide Additional Information to Participants Re-Consent Current Participants
Status of Participants Indicate if the participant(s) is/are still involved in the study. Still in the Study No Longer in the Study Not Applicable Status of Research Recruitment Indicate if participants are still being recruited into this study. Ongoing Completed (or Stopped) Not Applicable Status of Interventions/Interactions Indicate if participants are still being recruited into this study. Ongoing Completed (or Stopped) Not Applicable Impact on Participants Indicate if the event resulted in a violation of the participant’s rights, safety, or welfare. Yes No If Yes, explain how the event resulted in a violation of the participant's rights, safety, or welfare: Other Reporting Indicate where else you will be reporting this event to (check all that apply). Sponsor of Study Food and Drug Administration (FDA) Collaborating Investigators Data Safety Monitoring Board Not Applicable Other: Actions to Take As a result of the event, indicate the corrections/changes that you will be taking (if applicable) to resolve the current issue and/or prevent similar events from occurring in the future (check all that apply): Modification to Protocol/Study Procedures Modification to Level of Risk Modification to Consent Form Provide Additional Information to Participants Re-Consent Current Participants
eventreportform.docx