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 (January 2018). For specific types of reports, additional information may be needed.
When reporting protocol deviations, please ensure that your report includes at least a deviation summary log for major deviations and the deviation reporting form for minor or administrative deviations:
A research team or Sponsor may want to enroll a subject who does not meet the criteria outlined by the research protocol. A deviation report is needed if an ineligible subject is enrolled without IRB permission. However, an RNI can be submitted to the IRB requesting an exception to the eligibility requirements. For exception requests, please submit an RNI with the following exception request form.
When reporting Serious Adverse Events, please complete the submission in eIRB and also upload this SAE Report Form (October 2017).
NOTE: Additional documentation is needed when reporting external adverse events in multi-center trials. Please include:
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 Human Research Protection Program-Wichita at 316-293-2610 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 (September 2017) to assist you in the process of filing it under the specific study.