Guide to Reporting New Information
The table below includes a summary of problems and information that require reporting to HSD and the IRB, as well as the time frame for reporting and which form to use. Information, events and problems that are not research related do not need to be reported. Minor non-compliance only needs to be reported if it consists of an event or information listed in the table. When the components of the research are distributed across more than one institution or site, reporting requirements may differ depending upon the IRB review arrangements. For a more detailed description of HSDs reporting requirements, definitions, guidance and examples of what to report and what not to report, see SOP RNI Reporting by Researchers (Zipline studies) or PAPER SOP RNI Reporting by Researchers (Paper studies).
If you need help deciding what to report and what form to use, call HSD at 206.543.0098 and ask for a member of the Regulatory Affairs Team.
|Information or Event||When to report||How to report|
|Qualifying Medical Problem covered by the UW HSAP||Report within 24 hours||For studies in Zipline:
Follow the instructions to submit new information in Zipline, making sure to include the:
If the study also requires modification, follow the instructions on creating a modification in Zipline.
For paper studies:
Complete the PAPER REPORT: RNI form
If the new information also warrants a modification to the research, OR, only involves an incidental incarceration of a subject, a safety monitoring/DSMB report or revised IB, package insert, or device manual, complete the PAPER APPLICATION: Modification, Approved Project form. NOTE: revised Investigator Brochures (IB), package inserts, or device manuals only need to be submitted as a Modification. It is not necessary to submit a PAPER REPORT: RNI form.
Submit Modification-only submissions in hard copy to HSD Box 359470
Include as attachments any supplemental materials (e.g. revised IB, consent forms, DSMB or audit report).
|Breach (or risk of breach) or loss of subject confidentiality or privacy|
|Inappropriate access or use of protected health information (PHI)|
|Incidental incarceration of a research subject in a study that the IRB has not approved for the inclusion of prisoners and where study activities or data collection will continue while the subject is incarcerated||Report within 3 business days|
|For DOD funded EFICs studies only: All incidental incarceration of a research subject even if study activities and data collection will not occur during the incarceration|
|Unanticipated problem||Report within 10 business days|
|Unanticipated adverse device effect|
|Emergency deviation from IRB approved procedures made without IRB review to eliminate an apparent immediate hazard to a subject or others|
|Continuation of research after IRB approval has lapsed, because the procedures are of direct benefit to the individual subjects or withholding the researcher intervention (if any) may increase risks to subjects|
|Complaint from a subject or other person about the study, which cannot be resolved by the research team|
|Audit, inspection, compliance or safety-related inquiry from a federal agency including initial notification of an upcoming audit or inspection|
|Information that indicates a new or increased risk or safety issue (or a decrease in study benefits) (e.g. A publication in the literature indicates an increase in the frequency or magnitude of a previously known risk, or uncovers a new risk; revised IB, package insert, or device manual; changes to FDA-approved labeling, restrictions, or warnings)|
|Premature suspension or termination of some or all of the research by the sponsor, researcher, or institution|
|All safety monitor or DSMB reports|
|Change in credentialing, licensing, resources, or facilities that affect the research||For studies in Zipline:
Follow the instructions on creating a modification in Zipline.
For paper studies:
Complete the PAPER APPLICATION: Modification, Approved Project form and submit as instructed on the form.