Title
Category
Credits
Event date
Cost
Creating your Clinical Trial Protocol
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 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.
Two Successful Clinical Trialists Reflect on How They Got Their Start
  • 1.00 Participation
$0.00
Course DescriptionClaire Dees, MD, talks with Jared Weiss, MD and Carey Anders, MD, about their early experiences in running a clinical trial, including investigator-initiated clinical trials. Taking the CourseTo continue, click the button Take Course.
Protocol Amendments vs. Administrative Letters
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 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.  
IIT- Protocol Amendments
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 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.
5 Tips for Developing and Maintaining an IND
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through a quick 5 tips that will help you and your team successfully manage an IND.
Everything that a PI Needs to Know about Holding an IND
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 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.
IND Boot Camp
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 1.00 Participation
$0.00
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.
IIT FDA Annual Reports
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 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.
IND Safety Reporting- LCCC IITs
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 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.
Working with Investigational Assay Results
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 1.00 Participation
$0.00
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.

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