What needs to be reported?
All reports of new risk information, unanticipated problems, adverse events, non-compliance, audits and monitoring reports are now submitted in the electronic system. Please review the types of new information that should be reported (April 2017). For specific types of reports additional information may be needed.
When reporting protocol deviations, please ensure that your report includes at a minimum each of the following elements:
A reporting checklist and tool can help you when creating a deviation report
NOTE: Additional documentation is needed when reporting external adverse events in multi-center trials. Please include:
- The sponsor's determination that the event is an unanticipated problem, along with the sponsor's action plan to address the problem, or
- Documentation that the sponsor approves changes to the study (if the local PI has determined the event represents an unanticipated problem).
Reports without this documentation may be returned without review.
How quickly should I report something?
Reports should be submitted within 5 working days of an individual's knowledge of the event / information. Urgent information, or report of a study-related death, must be reported in 24 hours. Please feel free to contact the HSC Office at (913) 588-1240 with any questions about these new reporting guidelines.
How do I make a report?
Unlike a modification or CR, Reporting New Information can be associated with one or more studies, or with no study at all. Since most RNIs are associated with a specific study, please use the RNI Quick Start Guide (03/2017) to assist you in the process of filing it under the specific study.