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 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 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
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
  • Investigator Initiated Trials
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Everything a PI Needs to Know about LCCC as an IND Sponsor
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.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Everything that a PI Needs to Know about Holding an IND
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.
Category
  • Investigator Initiated Trials
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
IIT FDA Annual Reports
Course DescriptionNasrin Babadi, PhD takes you through how to write an IND annual report and the LCCC processes surrounding IND annual reports.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation

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