HSC Problem Reports Form for New Information by DVfdoh


									                                  THIS FORM CAN BE FOUND AT THE FOLLOWING LINK:

                              KUMC HUMAN SUBJECTS COMMITTEE
                             NEW INFORMATION REPORTING FORM

                                                OFFICE USE ONLY

                       Additional information required.
                       The new information represents no or minimal risk to study participants.
                         Signature below indicates approval by expedited review.
                       The new information represents greater than minimal risk. Referred to
                         HSC for evaluation: Meeting date: _____________

                      ______________________________________________       ______________
                      Signature HSC Chair or Designee                      Date

I.       Study Information

HSC#:               Principal Investigator:
Person Reporting Event:
Study Title and Protocol # (if applicable):

II.      Study Status

       Open to Enrollment; recruitment, enrollment and/or subject interventions are ongoing
       Closed to Enrollment, but       (enter number) subjects still receiving study intervention
       Closed to Enrollment, long-term follow-up or data/specimen analysis only
       Terminated; new information may affect previous subjects at KUMC

III.     Type of New Information

       Interim findings or status reports from Data and Safety Monitoring Boards, Data Monitoring
       Committees, or other central monitoring groups
       Sponsor-generated summaries of study-wide adverse events
       Suspension or termination of the study due to risk
       Publication that indicates an unanticipated change to risk/benefit ratio of the study
       FDA alert, withdrawal from marketing, or other FDA information impacting the risk/benefit ratio
       of the study
       Other new information that, in the opinion of the principal investigator, affects the welfare of
       current, previous or future subjects


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IV.         Assessment by the Principal Investigator

Does the new information negatively impact the safety and/or welfare of current KUMC subjects?

             Yes*         No          N/A (No current subjects or no enrollment to date)

Does the new information negatively impact the safety and/or welfare of previous KUMC subjects?

             Yes*         No            N/A (All subjects are undergoing study intervention)

*If either of the above questions is “Yes,” how many subjects are impacted?

V.      Proposed action, if the new information negatively impacts
        subjects (Check all that apply)

                Modification of the consent form
                Modification of study procedures
                Change in inclusion/exclusion criteria
                Additional monitoring through lab or other testing
                Provide additional information to current subjects
                Provide additional information to previous subjects
                Re-consenting of current subjects
                Increased frequency of interim data reviews
                Suspension of enrollment
                Suspension of study procedures
                Termination of the study
                Other modifications; describe
                N/A; Information does not negatively impact subjects

      VI.    Signature
      Principal Investigator __________________________________               Date

      Typed Name

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