Agenda: CRF Meeting 12/11/12

CSRC CRF Open Forum Meeting

December 11, 2012 at the White Oak Facility, FDA

Silver Spring, Maryland


7:30am-8:00am — Registration and Breakfast

8:00am-8:25am (Moderators: John Finkle and Mary Beth Sabol)

  • Concept behind/need for CV CRFs from Industry Perspective: John Finkle
  • Brief intro to forms and current concepts: Mary Beth Sabol
  • CEC Committess and how this type of data collection differs from typical CV outcomes trials: Ken Mahaffey
  • FDA Perspective on coordination of these forms with other efforts: Karen Hicks
  • Academica/Investigator: Daniel Lenihan
8:25am-8:50am – Cardiovascular and Death Forms: Goals & Objectives (Moderators: TBA)
  • Cardiac Safety Research Consortium: Mary Beth Sabol
  • Broad basic questions to be addressed at beginning:
  • What is the purpose of the forms?
  • What information do we want to gather?
  • Source data verifciation vs source documentation

8:50am-12:05am – Review Forms
  • Death (8:50-9:35)
  • FDA: Ellis Unger
  • CSRC: Mary Beth Sabol
  • MI/Unstable Angina (9:35-10:20)
  • FDA: Karen Hicks
  • CSRC James Tcheng
  • Break (10:20-10:35)
  • Heart Failure (10:35-11:20)
  • FDA: Shari Targrum
  • CSRC: Daniel Lenihan
  • Arrhythmias (11:20-12:05)
  • FDA: Norman Stockbridge
  • CSRC: John Finkle
  • Break to pick up bagged lunch (12:05-12:20)
12:20pm-3:30pm – Working Lunch and Review Forms

Deep Venous Thrombosis & Pulmonary Embolism (12:20-12:50)
FDA: Norman Stockbridge
FDA: Karen Hicks
CSRC: Daniel Lenihan

Pulmonary Hypertension (12:50-1:20)
FDA: Preston Dunnmon

Stroke/TIA (1:20-1:50)
FDA: Karen Hicks (Billy Dunn, John Marler)
CSRC: Philip Sager
Break (1:50-2:00)
Valvulopathy (2:00-2:30)
FDA: Shari Targum
Peripheral Arterial Thromboembolism (2:30-3:00)
FDA: Karen Hicks 
CSRC: Ken Mahaffey
Revascularization (3:00-3:30)
FDA: Karen Hicks
CSRC: James Tcheng

3:30pm-3:45pm – Wrap Up & Next Steps