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 Participation
Gene Therapy- FDA and Local Considerations
Course DescriptionIn this talk, which was presented to FDA, IRBs and study teams throughout the US, Kaitlin Morrison, PhD takes you through gene therapy trials and what you need to know about them beyond your typical IIT process.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Hot and Cold Topics for Investigators
Course DescriptionKaitlin Morrison, PhD takes you through the top topics investigators are asking about and the other questions that they should be asking too.These topics include:
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
LCCC’s Single Subject Exception Policy
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
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
Activation 101- Who are the Players
Course DescriptionKaitlin Morrison, PhD takes you through all the different players and roles involved in clinical trial activation.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Activation 201- What is the Role of the Activation PM
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.
Category
Format
  • Self-Paced, Online Courses
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 Participation
Project Management of CPO Trial Activation 101
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.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 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 Participation

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