THIS FORM CAN BE FOUND AT THE FOLLOWING LINK:
KUMC HUMAN SUBJECTS COMMITTEE
NEW INFORMATION REPORTING FORM
REPORT NEW INFORMATION TO HSC WITHIN 20 (TWENTY) WORKING DAYS OF NOTIFICATION TO THE PI.
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
Principal Investigator __________________________________ Date
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