Beginning in May, 2013, the CHR has been working closely with the CTSI’s Planning, Evaluation & Tracking (PET) program to assess the process for approving new Expedited and Full Committee Review research using Lean Six Sigma (LSS) methodology.

The project team first analyzed all of the new study submission processing data from the iRIS system to collect statistics and correlate data on:

• Number  of iterations
• Numbers of correction stipulations
• Time to first review
• Time spent with CHR vs. study team
• Committee review outcomes
• Overall time to approval (T2A)

The project team then worked with the CHR analysts who work on these submissions to identify areas where improvements would have the greatest impact.

In addition, in 2013 the CTSI funded a Pilot Award to Improve the Conduct of Research. The project aims to significantly decrease the duration of CHR approval time for Full Committee Review studies by reducing the number of applications returned to the study team for revision. Pre-review correction stipulations for the most recently submitted 50 full committee studies were reviewed and analyzed to assess the prevalence and types of preparation errors. These data will be used to improve the application form and help text provided.