1. CRC at CTSI Process Mapping & Gap Analysis Prepared by: Hilary Butler Dan Chen Anand Kulkarni Gaurav Srivastava Ingrid Warrner

2. Process overview Stage 1 Stage 2 Stage 3 2

3. Issues/Recommendations Protocol Approval/ Stage 1 –Inefficient tracking mechanism for pre- approval of studies/ Implement “live” online tracking system which feasibility team could input feedback. Planning/Stage 2 –SC and nursing staff fielding calls from potential study recruits/ Create a centralized hub to pre-qualify/screen subjects and direct to proper information source 3

4. Issues/Recommendations Planning/ Stage 2 –Duplicate of demographic information entry/ Develop a “one-stop” database that can be accessed by PI teams and CRC personnel Patient Visits/ Stage 3 –Operations Mgr overloaded with Webcamp/offload data entry of demographic info to admin asst. –Room scheduling/ Use Outlook type calendar system that would allow the SC or nurse to book the appt. when speaking with the pt. 4

5. Developed a Process Map/ SOPs A process map was created that will be a work in progress and we will need to drill down to specifics Confirmed the need for us to organize the location and specific SOPs that are pertinent to the CRC and develop ones that are specific to the activity within the process map 5

6. Gap analysis tool Found a tool for us to use to ensure that our SCs are meeting FDA GCP and ICH Guidelines It is a starting point where we can update and customize as we further develop our SOPs for each step of the process 6

7. Key takeaways Reduce manual processes by relying on integrated electronic systems –Fully utilize WebCamp or some other software to better track studies Streamline scheduling and ICD verification processes Implement a centralized recruiting center Improve documentation and develop SOPs 7