Safety Reporting – Sponsor/CROs

General Guidance – Protocol Level Safety and Unanticipated Problems

Quorum Review IRB requires reporting of all events that may constitute unanticipated problems involving risk to research participants or others as well as new or updated safety information relating to the study or study product. Reportable events/information must be reported to Quorum within 10 business days of their occurrence.

Typically, the investigator is responsible for submitting safety information; however, Quorum Review’s IRB services allows the sponsor to accept responsibility for submitting study-wide safety information to Quorum on behalf of all investigators involved with the study. The sponsor can make this choice by providing the appropriate information on the “Central Study Questionnaire.”

For additional guidance with specific examples regarding the types of incidents that require prompt reporting, Quorum strongly encourages all sponsors, Clinical Research Organizations, investigators and research staff to make use of the following resources:

The following study-wide safety information should be submitted to Quorum Review IRB when such information qualifies as a Reportable Event:

  • IND Safety Reports (i.e., external adverse events)
  • Device Reports
  • Data Safety Monitoring Board (DSMB) Summary Reports
  • FDA or sponsor Safety Alerts
  • Notification of product withdrawals
  • Recalls and clinical holds
  • Other relevant safety information

Investigator Brochures, Package Inserts, and Device Manuals

Quorum Review IRB requests that sponsors accept responsibility for submitting the following documents on behalf of investigators:

  • Investigator Brochures
  • Package Inserts
  • Device Manuals

When Investigator Brochures, Package Inserts, and Device Manuals are revised, Quorum Review IRB requires sponsors to submit a summary of changes along with the revised document to Quorum Review IRB on behalf of all investigators at the same time these revised documents are sent to investigators. In addition, it is especially helpful to provide a tracked version of the document showing the changes made.

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