IRB Safety Reporting

Research and Education > TriHealth Hatton Research Institute

Please use the forms below to report safety related issues or updates.

If you have any questions about reporting safety related issues please contact:

Christy Galioto at 513 865 5248 or irb_hrpp@trihealth.com  

Forms:

  • Unanticipated Problem Submission Form (PDF) – Should be used to report events that are Unanticipated/Unexpected, Related and Serious within 5 business days of occurrence or within 24 hours in the event of death – The IRB will acknowledge receipt and let you know if any further response is required.
  • IND/IDE Safety Submission Form (PDF) – Should be used to submit External Events not meeting the criteria for Unanticipated Problems but the Sponsor requests IRB notification.  The Serious Adverse Event Report should be attached (i.e., Medwatch, SUSARS) to the form – The IRB will acknowledge receipt and let you know if further response is required.
  • Protocol Deviation/Non-Compliance Form (PDF) - Should be used to report MAJOR protocol deviations and non-compliance issues that have an adverse effect on the safety and welfare of the subject subjects, data collected or are related to a breach of confidentiality within 10 business days of becoming aware of the issue – The IRB will acknowledge receipt and let you know if any further response is required.
  • Protocol Deviation Log (PDF) – Should be used to report MINOR protocol deviations only and should be submitted with your continuing review.
  • Safety Submission Form (PDF) – Should be used to report changes to Investigator Brochures, Package Inserts, Device manuals and to submit DSMB reports (as received), Annual Device Status reports, etc.  If the revisions require changes to the Protocol or Informed Consent, you must also submit a Modification Form.

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