Title
Category
Credits
Event date
Cost
Everything a PI Needs to Know about LCCC as an IND Sponsor
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through the sponsor responsibilities outlined by Good Clinical Practices (GCP) and FDA regulations and what LCCC infrastructure and processes are used to meet those obligations.
Everything that a PI Needs to Know about Holding an IND
  • Investigator Initiated Trials
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through all of the major responsibilities of holding an LCCC sponsored IND. She takes you through errors made in the past, so you can make sure that you don’t make them on your study.
Gene Therapy- FDA and Local Considerations
  • 1.00 Participation
$0.00
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. This includes insights into specific protocol requirements and additional review bodies that will oversee your study.
Hot and Cold Topics for Investigators
  • 1.00 Participation
$0.00
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:
IIT FDA Annual Reports
  • 1.00 Participation
$0.00
Course DescriptionNasrin Babadi, PhD takes you through how to write an IND annual report and the LCCC processes surrounding IND annual reports.
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.
IND Safety Reporting- LCCC IITs
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Kaitlin Morrison, PhD covers how to fill out a MedWatch report form and how/when/why to notify FDA of an SAE.
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.
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.
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.  

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