Reporting local information

Investigators must report the following information to the IRB within ten (10) business days of discovery, except as otherwise noted. All reportable items must be submitted on a Reportable Local Information Form. Non-local items requiring changes to the protocol should be reported on a Request for Amendment form.

Events to report

• Unanticipated Problems (UP) involving Risks to subjects or others:
  • a. Are unanticipated;
  • b. Are related or possibly related to participation in the research; and
  • c. Suggest that human subjects or others are at increased risk of harm

NOTE: UPs that involve a death must be reported to the IRB within 24 hours of discovery.4. A breach of confidentiality involving a subject (e.g. unapproved use or disclosure of PHI)

• Information that indicates a new or increased risk (change in the frequency or magnitude of risks or benefits):
  • a. An interim analysis or monitoring report
  • b. Published paper or presentation

• Withdrawal, restriction, or modification of drug/device/biological approval from the FDA or Sponsor
• A breach of confidentiality involving a subject (e.g. unapproved use or disclosure of PHI)
• Changes to the protocol made without prior IRB review to eliminate an apparent immediate hazard to subjects

NOTE: Changes made to eliminate risk must be reported to the IRB within 5 business days of discovery

• Complaint of a subject that indicated unexpected risks or that cannot be resolved by the study team.
• Audit, inspection, or inquiry by a Federal Agency (FDA 483, FDA Warning letters, FDA Audit reports, Notice of Disqualification, OHRP Determination letter, Debarment or Restricted list)
• Medical license suspension, restrictions or revocations, or any licensure or credentialing issues involving PI, co-PI, sub-I, or research staff
• Incarceration of a subject enrolled in a protocol not approved to enroll prisoners
• Protocol violations due to investigator or research staff
• Unanticipated adverse device effect (UADEs): Any serious effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application [including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects
• Any other problem that the PI believes needs to be reported promptly to the IRB
• Any conflict of Interest previously undisclosed or managed

Version 2019-8