Patient Study Calendar Subcommittee Kick Off

1. Patient Study Calendar Subcommittee Kick Off September 1st, 2009 Patient Study Calendar Subcommittee John Speakman Associate Director, Clinical Products and Programs Neesha Desai Patient Study Calendar Subcommittee Facilitator Center for Biomedical Informatics and Information Technology, NCI

2. Agenda • Recap of activities • Open ECOG Trials • Update on Pilot with ECOG Process • Evaluation Criteria Discussion • Next Steps

3. Proposed Activities • Define a standardized process to centrally create a study template that will be the common calendar on a given protocol consumed by local instances of PSC • Define a validation process to review and approve the templates before sharing the template • Consider Knowledge Center as a mechanism for distribution and feedback capture of validated PSC templates • Discuss where to centrally create the templates: CTSU, Lead Organization? • Determine mechanism for Cancer Centers without a centralized oversight group to create and utilize standardized templates.

4. Proposed Activities (cont.) • Define best practices and policies around PSC • Best practices for creating templates • Best practices for validating templates • Best practices for data elements on calendar templates • Policies around posting templates for distributed use

5. Open ECOG Trials • ECOG is nearing completion of ECOG 5103 • Study is being performed at NU, Thomas Jefferson University, and Mayo • NCCCP found E5202 and E2804 ECOG trials that all the NCCCP sites (16) actively participating • E5202 is on the CTSU menu.  Mayo participates in that study but it is temporarily closed • E2804 is not on the CTSU menu.  Mayo does participate in this study through ECOG.

6. PSC Pilot with ECOG Process • ECOG identified a resource to verify the ECOG 5103 template once it is complete • ECOG is verifying the template for ECOG 1505 also • Mayo has this trial open • Once these templates have been verified, they will post them to their website to be downloaded by cancer centers   • Note: ECOG has not committed to a specific timeline for this

7. PSC Pilot with ECOG • ECOG is interested in hosting PSC for its members that do not have the ability/willingness to do so for themselves.   • Would PSC be able to authenticate via the CTEP-IAM authentication system through a web service that CTSU provides?   • All of the cooperative group study coordinators, etc., are (or soon will be) in the CTEP IAM system.  CTSU enables that information to be available via a web service

8. Evaluation Criteria • How do we evaluate process improvement • Identify time savings • CRA time savings • Reducing deviations • Cost in generating templates • Efficient Site reviews • QC at centers • Other

9. Next Steps • Continue Pilot with ECOG • Do we have enough open trials or do we need to find additional trials? • What support does Rick and his team need from the PSC Subcommittee for this effort?

10. Questions / Contacts NCI Lead: John Speakman – NCI CBIIT john.speakman@nih.gov Patient Study Calendar Subcommittee Facilitator Neesha Desai – NCI CBIIT neesha.desai@nih.gov