Title
Category
Credits
Event date
Cost
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. 
Creating your Clinical Trial Protocol
  • Investigator Initiated Trials
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Leila Kiefer, PhD gives a survey of clinical protocol goals and best practices from literature, guidances, and experiential knowledge.
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.

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