February 10, 2017
7:30am- 8:00am Arrival, Security, and Continental Breakfast
8:00am-8:15am Welcome and Introduction of Participants: Theressa Wright, MD (Eli Lilly)
8:15am-8:30am Overview of Cardiac Safety Research Consortium: Mitch Krucoff, MD (Duke University Medical Center)
- CSRC Mission
- Partnership Expectations
- Successful projects and stakeholder access to shared data
8:30am-9:00am Overview of CSRC Prevention of SCDY initiative: Salim Idriss, MD, PhD (Duke University Medical Center)
- Background, timeline to date, participants, Think Tank outcomes
- Subgroups and current work to date
- Subgroup1 – Uniform data elements: Stuart Berger, MD (Lurie’s Children’s Hospital, Chicago)(5min)
- Subgroup2 – Digital data: Elizabeth Saarel, MD (Cleveland Clinic)(5 min)
- Subgroup3 – Outcomes: Victoria Vetter, MD (Children’s Hospital on Philadelphia)(5 min)
9:00am-9:20am FDA Perspective
- Lynne Yao, MD (10min)
- Norman Stockbridge, MD, PhD (10min)
9:20am-9:45am Introduction of Pilot Study – Rationale, Specific Aims, Study Roadmap, Gaps and Barriers: Salim Idriss, MD, PhD (Duke University Medical Center)
9:45am-10:00am Break
10:00am- 12:00 Focused Problem Solving Sessions
- 10:00am-11:05am Session 1: What are the specific core elements for this pilot? (Full dataset vs. smaller subset for pilot?) Moderator: Victoria Vetter, MD (Children’s Hospital on Philadelphia)
- 11:00am-12:00pm Session 2: How do we unify data collection? (Paper, digital acquisition, screening group education, data storage and transfer) Moderator: Stuart Berger, MD (Lurie’s Children’s Hospital, Chicago)
12:00 pm- 12:30 pm Working Lunch
- 12:30pm-1:30pm Session 3: How do we ensure quality ECG data collection? (Machines, lead placement, digital data, XML) Moderator: Elizabeth Saarel, MD (Cleveland Clinic)
- 1:30pm-2:30pm Session 4: What Echo data for this pilot study? (Who, what machines, data storage and transfer) Moderator: Elizabeth Saarel, MD (Cleveland Clinic)
- 2:30pm-3:00pm Session 5: How do we optimize logistics, timelines, and engagement of all partners? Moderator: Theressa Wright, MD (Eli Lilly)
3:00pm-3:30pm Next Steps: Salim Idriss, MD, PhD (Duke University Medical Center)