March 6-7, 2019
The first EFS workshop of 2019 focusing on site best practices took place on March 6th & 7th at the MDIC offices located in Arlington, VA. In this workshop, sponsors, EFS sites, and regulators gathered over a two-day period to discuss:
• Managing risk, SAEs, & IRB reporting
• Timely & Effective Contracting-Sites Achieving 60/60/60 or Better
• Budgeting between EFS Sites and Sponsors
• EFS Staffing and Resources-Patient Identification, Enrollment, & Retention
• Coverage Determinations & Site Budgets.
Throughout the workshop, Sponsors and Sites gave their perspectives of best practices for EFS clinical studies. Sponsors highlighted the importance of collaborating with the FDA to structure protocols for quick patient enrollment and conducting site qualification visits early prior to protocol finalizations. From the site perspective, the importance of working with highly engaged and qualified research staff, as well as collaborating with IRB, was emphasized as key points to improve the launch of an EFS clinical study.
Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.
Individual Event Materials:
Agenda & List of attendees
Workshop Overview | Chip Hance, MDIC EFS Initiative Board Champion
EFS Overview | Andrew Farb, MD, FDA, CDRH
EFS Value to Innovation | Rick Geoffrion, Mitralign, Inc.
EFS Best Practices: Importance of Identifying Them | Martin Leon, MD, Mayo Clinic
Session II: Timely & Effective Contracting | Jaime Walkowiak, BSWI
Session III: Budgeting Between EFS Sites and Sponsors
Learnings From Sites Achieving “60:60:60” or Better | Beth Wilson, OHSU
Learnings From Sites Achieving “60:60:60” or Better | Lynne Goodreau, Northwestern
EFS in the context of FDA Priorities and Initiatives | Bram Zuckerman, MD, FDA, CDRH
Session V: Patient Identification, Enrollment, & Retention | Sara Vidmar, preCARDIA
Session V: Patient Identification, Enrollment, & Retention | Necole Kell, BSWRI
Session VI: Coverage Determination & Site Budgets | Jill Trekell, Edwards Lifesciences
Conclusions & Next Steps
Full Event PDF Packet:
2019 EFS Best Practices Materials