IRBCo requires reporting of all events that are considered unanticipated problems involving risk to study subjects or others. Also, any new or updated safety information relating to the study and products provided as part of the study. Any events or new information must be reported to IRBCo within 10 days of the occurrence. Submission of safety reporting and documents should be submitted through eProtocol. Following is a list of items that qualify as a reportable event:
- IND Safety Reports
- Device Reports
- FDA or sponsor safety alerts
- Data Safety Monitoring Board Reports
- Updated Investigator Brochures
- Updated Package Inserts
- Updated Device Manuals
- Other relevant safety information
These items may be submitted by the Sponsor/CRO on behalf of all sites in the study. Changes to previously reviewed documents should be submitted with a summary of changes and the final new version of the document. PI’s must report safety information if the sponsor does not submit on their behalf. Also, the PI is responsible for reporting any events relating to the study or the study product which occur at their specific study site. The PI must report any event that is Serious, Unanticipated and Related to the study product or procedures. If the event meets all three requirements it must be reported through eProtocol.
IRBCo will acknowledge the documents through the eProtocol system.
