The LLUH IRB is pleased to announce a new streamlined process for reporting Serious Adverse Events and Unanticipated Problems. All reports are to now be submitted electronically through InfoEd. The link and guidance documents can be found on the IRB toolkit webpage at: https://researchaffairs.llu.edu/research-compliance/human-studies/irb-toolkit. Please note that if a Principal Investigator is not submitting the report themself, then they will need to login to InfoEd to sign off on the report prior to it being submitted to IRB.
A chart is attached to help determine if your Serious Adverse Event or Unanticipated Problem is reportable and if so, what the timeline is to report.
We are now one step closer to all submissions being fully electronic. As always, if you should have any questions or concerns, please do not hesitate to contact the LLUH IRB at: IRB@llu.edu
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