Clinical Research Management Workshop June 23, 2009

1. Opportunities for Shared Learning within the CTSA Consortium and with the Broader Research Community Clinical Research Management Workshop June 23, 2009

2. Opportunities for Sharing • Content • Research tools • Best practices • Resource inventories • Venues • Pubmed • Professional Society websites • Academic center websites • NIH and other research sponsor websites

3. Clinical Trials Network Best Practices • One model for sharing • Example of leveraging federal funding into public-private partnership • Initially funded through NIH Roadmap initiative • Now funded through institutional and industry funding sources • Open access to all clinical research sites • CTNBestPractices.org

4. CTNBestPractices.org • CTNBP was created to: • Support a collaborative network of clinical-research professionals, sites, and organizations; • Improve the conduct of clinical research by defining and disseminating best practices; and • Standardize research tools. • A Study Coordinator Advisory Committee (SCAC) of 10 research coordinators, representing 9 clinical sites, created this publicly-accessible Web site to house in one location the tools, templates, and training that would assist clinical sites.

5. CTN Best Practices – Home Page

6. SOP Templates Adverse Events Case Report Forms Closeout Visit Electronic Case Report Forms FDA Inspection HIPAA Policy Informed Consent Training Tools Education/Training Log (Word) Template: Memo to File Re Training (Word) Template: Memo to File Re Ongoing Training (Word) Training Sign-in Sheet (Word) Recommended CTNBP Training for Research Personnel CTN Best Practices – Sample of Content

7. Summary CTSA Consortium should remain vigilant: • To opportunities for shared learning within and outside of the Consortium • To potential for external funding sources • To not “reinvent the wheel” • To ensure “consumer” participation by involving appropriate stakeholders