Title
Category
Credits
Event date
Cost
LCCC’s Single Subject Exception Policy
  • 1.00 Participation
$0.00
Course DescriptionIn this talk by Kaitlin Morrison, PhD and Carrie Lee, MD, MPH, Kaitlin takes your through LCCC’s policy on single subject exceptions, why we do not allow eligibility single subject exceptions on IITs and what the process is to ensure proper regulatory approval for other types of single subject exceptions.
Understanding when Assays become Investigational Assays
  • 1.00 Participation
$0.00
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. Taking the CourseTo continue, click the button Take Course.
Activation 101- Who are the Players
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through all the different players and roles involved in clinical trial activation.
Activation 201- What is the Role of the Activation PM
  • 1.00 Participation
$0.00
Course DescriptionThis talk given by Kaitlin Morrison, PhD takes you through the role of the activation project manager and how they facilitate activation of treatment clinical trials. 
What is a “Critical Path” and How Can it Help Me?
  • 1.00 Participation
$0.00
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.
Project Management of CPO Trial Activation 101
  • 1.00 Participation
$0.00
Course DescriptionThis lecture takes you through business principles as defined by “Project Management: A Systems Approach to Planning, Scheduling and Controlling” by Harold Kernzer. Kaitlin Morrison, PhD will cover what is traditional vs. matrix management, what project management is, and how project managers collaborate with line managers. She will then talk about how these processes can be used to facilitate clinical trial activation.
IIT- Protocol Amendments
  • 1.00 Participation
$0.00
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.
Protocol Amendments vs. Administrative Letters
  • 1.00 Participation
$0.00
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.  
Two Successful Clinical Trialists Reflect on How They Got Their Start
  • 1.00 Participation
$0.00
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. Taking the CourseTo continue, click the button Take Course.
The "Tiny" Details that Can Wreak Havoc with a Protocol: Improve Protocol Development to Avoid Amendments
  • 1.00 Participation
$0.00
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.

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