Investigator Initiated Trials | UNCLCN Learning Portal

Investigator Initiated Trials

Investigator Training

Developing, writing, operationalizing, and conducting clinical trials is incredibly complex. To aid in investigator continuing education about some of these complex processes, we have put together the following on-demand lectures. They cover a variety of topics from creation of a clinical trial to responsibilities associated with sponsoring a clinical trial to business principles surrounding project management of activating clinical trials.

Meet the Team Getting Started

This content is hosted on the UNCLCN Learning Portal.
For questions or technical issues,please contact [email protected]u or call 919-445-1000

Protocol Development

Creating your Clinical Trial Protocol

Two Successful Clinical Trialists Reflect on How They Got Their Start*

Protocol Amendments vs. Administrative Letters

IIT- Protocol Amendments

The "Tiny" Details that Can Wreak Havoc with a Protocol: Improve Protocol Development to Avoid Amendments

FDA- INDs and IDEs

5 Tips for Developing and Maintaining an IND

Everything that a PI Needs to Know about Holding an IND

IND Boot Camp

IIT FDA Annual Reports

IND Safety Reporting- LCCC IITs

Working with Investigational Assay Results

Sponsor Responsibilities

Everything a PI Needs to Know about LCCC as an IND Sponsor

Site Perspective: Examine the Process for Maintaining Quality and Ensuring Results

Advanced Trainings IIT trainings

Gene Therapy- FDA and Local Considerations

Hot and Cold Topics for Investigators

LCCC’s Single Subject Exception Policy

Understanding when Assays become Investigational Assays*

Regulatory and Clinical Development Considerations for Chimeric Antigen Receptor (CAR) T Cells

Clinical Trial Activation

Activation 101- Who Are the Players

Activation 201- What Is the Role of the Activation PM

What Is a “Critical Path” and How Can it Help Me?

Project Management of CPO Trial Activation 101

Disclaimer

Disclaimer

The views expressed herein are those of the presenter, they do not necessarily reflect the views of the contracted organization, department, School of Medicine, nor the University of North Carolina at Chapel Hill.

Submitted by Andrew Dodgson on Thu, 12/02/2021 - 3:55pm

Group:

Subscribe to group

Group visibility:

Public - accessible to all site users