|
8:00 to 8:30 |
Registration and Continental Breakfast |
|
8:30 to 9:00 |
Introduction & Pre-Test |
|
9:00 to 9:25 |
Study Start-Up: Ethical Foundations |
|
9:25 to 9:50 |
Study Start-Up: Overview of Research Regulations |
|
9:50 to 10:05 |
Break |
|
10:05 to 11:05 |
Study Start-Up: Drug Development & Trial Design, Investigational New Drug Application & Expanded Access |
|
11:05 to 12:05 |
Study Start-Up: Device Development |
|
12:05 to 12:50 |
Lunch (Provided) |
|
12:50 to 1:50 |
Conduct of Study: Clinical Protocols, Sponsor, Investigator & Monitor Responsibilities & Financial Disclosure |
|
1:50 to 2:05 |
Conduct of Study: Institutional Review Board (IRBs) |
|
2:05 to 2:20 |
Break (with opportunity for discussion) |
|
2:20 to 3:20 |
Conduct of Study: Informed Consent |
|
3:20 to 3:40 |
Conduct of Study: Managing Study Compliance and Safety Reporting |
|
3:40 to 3:45 |
Study Close-Out: Study Closure/Record Retention and Regulatory Submission/Postmarket |
|
3:45 to 4:00 |
Conduct of Study: Inspections and Audits |
|
4:00 |
Q&A |