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 FormsDeep Venous Thrombosis & Pulmonary Embolism (12:20-12:50)FDA: Norman StockbridgeFDA: Karen HicksCSRC: Daniel LenihanPulmonary Hypertension (12:50-1:20)FDA: Preston DunnmonStroke/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 HicksCSRC: Ken Mahaffey Revascularization (3:00-3:30)FDA: Karen HicksCSRC: James Tcheng3:30pm-3:45pm – Wrap Up & Next Steps