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
Format
Credits
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
IND Boot Camp
Course DescriptionIn this talk, targeted at the CPO regulatory team, Kaitlin Morrison, PhD talks through how INDs are maintained at LCCC and the responsibilities of study team members.
Category
Format
  • Self-Paced, Online Courses
Credits
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
IND Safety Reporting- LCCC IITs
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.
Category
Format
  • Self-Paced, Online Courses
Credits
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
Working with Investigational Assay Results
Course DescriptionKaitlin Morrison, PhD takes you through when a correlative assay is considered an FDA regulated device and what types of devices require different levels of IRB and FDA approval.
Category
Format
  • Self-Paced, Online Courses
Credits
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • Participation

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