Title
Category
Credits
Event date
Cost
Hot and Cold Topics for Investigators
  • 1.00 Participation
$0.00
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:
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.
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.
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.
LCCC’s Single Subject Exception Policy
  • 1.00 Participation
$0.00
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 proper regulatory approval for other types of single subject exceptions.
Project Management of CPO Trial Activation 101
  • 1.00 Participation
$0.00
Course DescriptionThis lecture takes you through business principles as defined by “Project Management: A Systems Approach to Planning, Scheduling and Controlling” by Harold Kernzer. Kaitlin Morrison, PhD will cover what is traditional vs. matrix management, what project management is, and how project managers collaborate with line managers. She will then talk about how these processes can be used to facilitate clinical trial activation.
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.  
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.
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.
Understanding when Assays become Investigational Assays
  • Investigator Initiated Trials
  • 1.00 Participation
$0.00
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. Taking the CourseTo continue, click the button Take Course.

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