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
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
  • 1.00 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
  • 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
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
  • 1.00 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
  • 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
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
Format
Credits
  • 1.00 Participation
Improving AI/AN cancer surveillance data in the US - SPOC
Melissa Jim, MPH will describe our IHS linkage and characterize patterns of cancer incidence among AI/AN by IHS Region. We will discuss sources of AI/AN cancer data. I will also explore the United States Cancer Statistics: Data Visualizations website to show how to find AI/AN cancer data by IHS Region. Accurate cancer data is crucial to develop public health strategies and programs to address cancer disparities.
Category
  • Southeastern American Indian Cancer Health Equity Partnership
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation
Embracing Indigenous Wisdom in Evidence Based Cancer Prevention: A Path of Collaboration, Respect, and Insight on Duke's Voyage
Embracing Indigenous Wisdom in Evidence Based Cancer Prevention: A Path of Collaboration, Respect, and Insight on Duke’s Voyage” is a presentation that explores the partnership between modern scientific research and indigenous wisdom in the pursuit of effective cancer prevention strategies. It underscores the humility in learning from indigenous knowledge, and the discovery of insights that can enhance evidence-based approaches to cancer prevention.
Category
  • Southeastern American Indian Cancer Health Equity Partnership
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 Participation

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