Close Out

Close-out:  There are three types of study close outs:

1. Closure of study to recruitment, i.e. the required number of subjects stated in the protocol to complete study objectives has been completed.  Notify the IRB via BRAAN to stop enrollment or contact them at 852-5188 or Service Account: hsppofc@louisville.edu for assistance.  You must also change the study’s enrollment profile on http://clinicaltrials.gov/ if this is a PI initiated study.  The sponsor will change that designation to “closed to enrollment”, if it is industry sponsored.
2. When the study is closed to enrollment keep the study open for IRB purposes, because the monitor must still have access to the research data and source documents.  Thus the second close-out is when the data has been reviewed, all queries have been answered, and the data has been analyzed.
3. The third close-out step is the completion of all budgetary transactions. All payments and billing must be completed.  For assistance with this step contact your division/department UBM.  If they need assistance contact:  Sponsored Programs Financial Administration at 852-2980 or  http://louisville.edu/research/offices/spfa/spfa.html or if the Office of Clinical Research Support and Services has assisted you in the budgetary process contact them at https://louisville.edu/research/ocrss/about) .