Creating your Clinical Trial Protocol
Course DescriptionIn this talk, Leila Kiefer, PhD gives a survey of clinical protocol goals and best practices from literature, guidances, and experiential knowledge.
Category
Format
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 1.00 Participation
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
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
Format
Credits
  • 1.00 Participation
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
Format
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 1.00 Participation
Regulatory and Clinical Development Considerations for Chimeric Antigen Receptor (CAR) T Cells
Course DescriptionIn this talk, Kaitlin Morrison, PhD takes you through the what you should consider when doing preclinical, manufacturing and clinical work involving Chimeric Antigen Receptor (CAR) T cells.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
The "Tiny" Details that Can Wreak Havoc with a Protocol: Improve Protocol Development to Avoid Amendments
Course DescriptionIn this talk, Kaitlin Morrison, PhD will take to you about the 3 major reasons that protocols requirement amendments and how to avoid them.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
Site Perspective: Examine the Process for Maintaining Quality and Ensuring Results
Course DescriptionIn this talk, Kaitlin Morrison, PhD will take you through how to develop and implement a quality management plan to ensure you get good clinical trial results on your investigator-initiated trial (IIT).
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
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 AMA PRA Category 1 Credit
  • 1.00 Participation
IIT- Protocol Amendments
Course DescriptionNasrin Babadi, PhD takes you through LCCC’s processes for amending protocols and submitting them to FDA talking about key tips on how to best edit your protocol and applicable FDA regulations for submitting your protocol.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
5 Tips for Developing and Maintaining an IND
Course DescriptionKaitlin Morrison, PhD takes you through a quick 5 tips that will help you and your team successfully manage an IND.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation

Pages