Educational Videos

If you are interested in using the training modules to train IND and IDE sponsors at your institution, please complete the online request form to obtain the proper permission and access to the files in a format that will meet your needs. The modules are available in a format compatible with most Learning Management Systems (LMS) to give the ability to track registration and completion of training, and they also include a 10-question learning assessment. The modules are also available in an HTML format for web viewing and as PDFs.

Investigational New Drug or Biologic (IND)

Training Modules on IND Sponsor and Investigator Responsibilities

These training modules cover the responsibilities associated with maintaining an IND and are intended for academic investigators who will hold an IND.

The first nine modules cover IND sponsor responsibilities and the final module will cover the responsibilities that must be fulfilled by investigators who conduct a clinical investigation run under an IND. Investigators fulfilling a dual role as sponsor and investigator, in other words sponsor-investigators, must fulfill the responsibilities of both sponsors and investigators.

Investigational Device Exemption (IDE)

Training Modules on IDE Sponsor and Investigator Responsibilities

These training modules cover the responsibilities associated with maintaining an IDE and are intended for academic investigators who will hold an IDE for a significant risk device study.

The first nine modules cover IDE sponsor responsibilities and the final module will cover responsibilities that must be fulfilled by investigators who conduct a significant risk device study run under an IDE. Investigators fulfilling a dual role as sponsor and investigator, in other words sponsor-investigators, must fulfill the responsibilities of both sponsors and investigators.

ClinicalTrials.gov

Workshops

Clinical Protocol Development Workshop