Standardized Data Collection for Cardiovascular Trials
STANDARDIZED DATA COLLECTION FOR CARDIOVASCULAR TRIALS
September 11, 2009
FINAL AGENDA and PRESENTATIONS
(to view a presentation, click the title below)
9:00AM - Welcome and Introduction |
9:05AM - An Overview of the December 2008 Diabetes Cardiovascular Guidance |
9:10AM - FDA Study Data Standards: Current Status |
9:25AM - NIH Roadmap Projects for Therapeutic Data Standards: Case Studies in Tuberculosis & Acute Coronary Syndrome |
9:40AM - HL7 |
9:55AM - Critical Path Perspective on Collaborations to Support Data Standards |
10:00AM - Clinical Trials Transformation Initiative |
10:05AM - What Makes a Good Cardiovascular Trial - DCRP Medical Officer Perspective |
10:10AM - What Makes a Good Cardiovascular Trial - DMEP Medical Officer Perspective |
10:15AM - What Makes a Good Cardiovascular Trial - DCRP Biometrics Perspective |
10:20AM - What Makes a Good Cardiovascular Trial - DMEP Biometrics Perspective |
10:25AM - CDRH Requirements for Cardiovascular Trials |
10:30 - Open Questions |
11:00AM - BREAK |
11:15AM - DCRI Data Collection: The Approach and Rationale |
11:20AM - ACC/AHA "Top 100" Cardiology Lexicon for Electronic Health Record (EHR) Systems |
11:25AM - Update on ARC Classification of Stent Thrombosis |
11:30AM - What Device Safety and Clinical Endpoint Information We Should Capture in Case Reprot Forms: Special Sex Consideration |
11:35AM - Standardizing Data Collection and Endpoints in Clinical Trials: Overcoming the Challenges |
11:40AM - The Challenges in Defining Endpoints |
11:45AM - How the CEC Adjudicates - The Challenges and the Pitfalls (Cleveland Clinic Perspective) |
11:50AM - Balancing Sensitivity of Detection with Clinically Meaningful Myocardial Infarction in Follow-up of Cardiovascular Trials |
11:55AM - Panel Discussion - Discussing the Gray Areas |
12:25AM - LUNCH |
1:05PM - DMEP Caridovascular Outcomes Trials |
1:10PM - Update on Testing the Proposed Standardized Definitions |
1:15PM - Perspective on Standardized Definitions and Data Collection for Cardiovascular Trials |
1:20PM - Standardized Data Collection for Cardiovascular Trials - Implications for Global Clinical Development |
1:25PM - 30 Years of CRF Standardization Efforts |
1:30PM - European Perspective on Cardiovascular Outcome Trials |
1:40PM - Panel (Open Questions) |
2:00PM - Standardized Case Report Form for Cardiovascular Trials |
3:45PM - Wrap-up/Future Plans/Adjournment |