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.
- Welcome to ReGARDD
- Overview Of Quality Assurance For IND & IDE Studies
- Overview Of Manufacturing For IND & IDE Studies
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.
- Introduction to IND Sponsor and Investigator Responsibilities
- Overview of IND Maintenance and Tracking
- IND Annual Reports
- IND Protocol Amendments
- IND Safety Reporting
- IND Information Amendments
- Maintaining Accountability Records for INDs
- IND Monitoring and Multi-Center Trials
- Financial Disclosure
- IND Investigator Responsibilities
Investigational Device Exemption (IDE)
- IDE Overview
- Determining if IDE is Required
- Determining Significant Risk vs. Non-significant
- Off-Label Use Of A Device-Study Risk Determination & IDE Submission
- Preparing an IDE Application
- FDA Responses to Initial IDE Submission
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.
- Introduction to IDE Sponsor and Investigator Responsibilities
- Overview of IDE Maintenance and Tracking
- IDE Progress Reports and Final Reports
- IDE Modifications
- Unanticipated Adverse Device Effects
- IDE Reports
- Maintaining Accountability Records for IDEs
- IDE Monitoring and Multi-Center Trials
- Financial Disclosure
- IDE Investigator Responsibilities
ClinicalTrials.gov
- What Is ClinicalTrials.gov?
- ClinicalTrials.gov Tutorial
- Maintaining Compliance With ClinicalTrials.gov
- The Consequences Of Not Registering Through ClinicalTrials.gov
- The Responsible Party For ClinicalTrials.gov
- Registration Through ClinicalTrials.gov