Study Close Out

After enrollment is closed, all follow-up data has been collected, utilization of subject PHI is no longer required, and the final data analysis is complete, the study is considered to be in the Closeout Phase. During this phase, data is prepared for final analysis, regulatory and reviewing bodies are notified of study closure, investigational product inventory is reconciled, and final reports are submitted. Also, contact the following areas to ensure system are properly closed.  

  • IRB  

  • Clinical Research Finance (PennChart record and residual balance transfers)