8:00 to 8:05 |
Introduction - Disclosure of Relationships |
8:05 to 8:35 |
Study Start-Up: Ethical Foundations |
8:35 to 9:00 |
Study Start-Up: Overview of Research Regulations |
9:00 to 9:15 |
Break |
9:15 to 10:15 |
Study Start-Up: Drug Development & Trial Design, Investigational New Drug Application & Expanded Access; Post Market Surveillance |
10:15 to 10:45 |
Study Start-Up: Device Development |
10:45 to 11:30 |
Conduct of Study: Clinical Protocols; Sponsor Responsibilities |
11:30 to 1:00 |
Lunch (on your own) |
1:00 to 1:40 |
Conduct of Study: Investigators and Monitors Responsibilities; Financial Disclosure |
1:40 to 2:25 |
Conduct of Study: Institutional Review Board (IRBs) |
2:25 to 3:10 |
Conduct of Study: Informed Consent |
3:10 to 3:20 |
Break |
3:20 to 3:50 |
Conduct of Study: Managing Study Compliance; Safety Reporting |
3:50 to 4:30 |
Study Close-Out: Study Closure/Record Retention; Regulatory Submission |
4:30 to 4:50 |
Conduct of Study: Inspections and Audits |
4:50 to 5:00 |
Resources and Final Questions |