Protocol Amendments vs. Administrative Letters
Course DescriptionIn this talk, Kaitlin Morrison, PhD discussing what an administrative letter is and when an administrative letter can be used to clarify a clinical protocol versus when a full amendment is required. 
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Cost $0.00
IND Boot Camp
Course DescriptionIn this talk, targeted at the CPO regulatory team, Kaitlin Morrison, PhD talks through how INDs are maintained at LCCC and the responsibilities of study team members.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Cost $0.00
Two Successful Clinical Trialists Reflect on How They Got Their Start
Course DescriptionClaire Dees, MD, talks with Jared Weiss, MD and Carey Anders, MD, about their early experiences in running a clinical trial, including investigator-initiated clinical trials.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Cost $0.00
Understanding when Assays become Investigational Assays
Course DescriptionIn this talk Mike Matamoros, MS, CIP and Cassie Myers, CIP take you through IRB regulations about investigational assays, using COVID-19 assays as examples. 
Category
  • Investigator Initiated Trials
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Cost $0.00
What is a “Critical Path” and How Can it Help Me?
Course DescriptionKaitlin Morrison, PhD takes you through the business principles of critical paths, PERT charts and Gantt charts and how they can be used to streamline clinical trial activation.
Category
  • Investigator Initiated Trials
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Cost $0.00
Working with Investigational Assay Results
Course DescriptionKaitlin Morrison, PhD takes you through when a correlative assay is considered an FDA regulated device and what types of devices require different levels of IRB and FDA approval.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Cost $0.00

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