• Submission of Sponsor IND Safety Reports
• IND Safety Reports Flowchart

• Reporting Protocol Deviations
• Deviations Flowchart

• How and When a Principal Investigator Should Report Death of a JHM Research Participant
• Organization Policy on Reporting Death of a JHM Research Participant (Policy No. 103.6(b)(i))

Unanticipated Events

• Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others (Policy No. 103.6(b))
  All adverse events, adverse device effects, and unanticipated problems, including major protocol deviations not approved by the IRB.
• Unanticipated Events Flowchart

• Maryland Reporting Obligations that May Apply to Investigators or Other Members of the Research Team
• Reporting to the Institution and Government Agencies
  IRB report of investigator’s serious and continuing non-compliance, or suspension or termination of study