Reporting New Information / Events
What needs to be reported to the IRB?
All reports of new risk information, unanticipated problems, adverse events, non-compliance, audits and monitoring reports are now submitted in the electronic system. New information falls into three categories:
- Events or information that require prompt reporting to the IRB
- Events or information that can be submitted at the time of Continuing Review
- Events or informaiton that is submitted only to the sponsor or other parties as specified in the protocol.
As a quick reference, you may consult the guidance entitled Key Questions to Consider When Reporting Problems in Research (Mar 2018).
Detailed instructions are presented in the types of new information that should be reported document (April 2018). For specific types of reports, additional information may be needed as described below.
When reporting protocol deviations to the IRB, please complete the submission in eIRB and also upload the Deviation reporting form below. Additionally, all deviations, including major deviations as well as minor or administrative deviations, should be maintained by the study team on a deviation summary log.
When reporting Serious Adverse Events to the IRB, please complete the submission in eIRB and also upload this SAE Report Form Oct 2017.
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)
External 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 (09/2017) to assist you in the process of filing it under the specific study.