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Wednesday, December 3 |
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12:00 to 12:05 |
Introduction - Disclosure of Relationships |
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12:05 to 12:35 |
Study Start-Up: Ethical Foundations |
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12:35 to 1:00 |
Study Start-Up: Overview of Research Regulations |
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1:00 to 2:00 |
Study Start-Up: Drug Development & Trial Design, Investigational New Drug Application & Expanded Access; Post Market Surveillance |
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2:00 to 2:15 |
Break |
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2:15 to 2:45 |
Study Start-Up: Device Development |
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2:45 to 3:25 |
Conduct of Study: Clinical Protocols; Sponsor Responsibilities |
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3:25 to 4:00 |
Conduct of Study: Investigators and Monitors Responsibilities; Financial Disclosure |
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Thursday, December 4 |
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12:00 to 12:05 |
Join Webinar |
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12:05 to 12:50 |
Conduct of Study: Institutional Review Board |
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12:50 to 2:00 |
Conduct of Study: Informed Consent |
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2:00 to 2:10 |
Break |
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2:10 to 2:50 |
Conduct of Study: Managing Study Compliance; Safety Reporting |
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2:50 to 3:00 |
Study Close-Out: Study Closure/Record Retention; Regulatory Submission |
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3:00 to 3:50 |
Conduct of Study: Inspections and Audits |
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3:50 to 4:00 |
Resources and Final Questions |