Title
Category
Credits
Event date
Cost
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.
Protocol Amendments vs. Administrative Letters
  • 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.  
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.
The "Tiny" Details that Can Wreak Havoc with a Protocol: Improve Protocol Development to Avoid Amendments
  • 1.00 Participation
$0.00
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.
5 Tips for Developing and Maintaining an IND
  • 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.
IND Boot Camp
  • 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 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 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 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.
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.

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