Regulatory Affairs
The Regulatory Affairs team guides investigators and research teams on the regulatory processes of research involving drugs, biologics, and medical devices to support compliance with regulatory requirements, including those set by the FDA, HHS, and the IRB.
Investigational New Drug (IND)/Investigational Device Exemption (IDE) Program
The Regulatory Affairs Team with the Office of Research Integrity and Compliance (ORIC) provides regulatory support to Sponsor-Investigators for IND/IDE submissions to the FDA, including regulatory strategy, guidance on study design, FDA meeting support and submission requirements.
Sponsor-Investigators should notify ORIC when intending to serve as a Sponsor-Investigator for a clinical investigation of an FDA regulated test article by completing the IND/IDE Notification and Intake Form below. This form should be completed as early as possible in the project development process to best streamline regulatory review and overall submission process.
IND/IDE Notification and Intake Form
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration to administer an investigational drug or biological product to humans.
For more information on INDs, please see Investigational New Drug Applications (INDs).
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.
For more information on IDEs, please see Investigational Device Exemption (IDE).
Per 21 Code of Federal Regulations Part 312 Subpart D -- Responsibilities of Sponsors and Investigators, the Sponsor is the party responsible for submitting all IND or IDE applications. In an IIT, the Investigator is serving as the Sponsor-Investigator meaning they are responsible for all sponsor and all investigator responsibilities.
Therefore, the Investigator is the responsible party for the Sponsor duty of submitting the IND or IDE application.
If it is still unclear whether a research study is exempt, please contact us for additional guidance.
The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) program is comprised of regulatory affairs specialists and experts from the University of North Carolina at Chapel Hill, Duke University, Wake Forest School of Medicine, RTI International, the Medical University of South Carolina, Virginia Commonwealth University, and University of Miami to provide academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics, and medical devices.
To help understand and meet the responsibilities of the Sponsor-Investigator, please review the ReGARDD Sponsor-Investigator training modules.
Templates and resources are available to support IND/IDE submissions to the FDA. Please complete the IND/IDE Notification and Intake Form and the Regulatory Affairs team will reach out to schedule a discussion and provide you with the appropriate resources.
IND/IDE Notification and Intake Form
For Sponsor-Investigator FDA reporting requirements, visit:
ClinicalTrials.gov
The Regulatory Affairs and Quality Assurance team is developing resources to support Sponsor-Investigators with maintaining accurate and up-to-date records within ClinicalTrials.gov. While a dedicated webpage is under construction, please contact ctgov@luriechildrens.org for guidance or assistance with user access, study registration, and results reporting.
For assistance in determining if a trial meets registration and reporting requirements, please see the following resources:
- Lurie Children's Clinical Trials Registration and Reporting Policy v.1
- CT.gov Clinical Trial Reporting Requirements
- Requirements for Registering & Reporting NIH-Funded Clinical Trials - Grants & Funding
- International Committee of Medical Journal Editors (ICMJE) Registration Recommendations for Clinical Trials
- PCORI's Process for Peer Review of Primary Research and Public Release of Research Findings
The Responsible Party (RP) conducting an Applicable Clinical Trial (ACT) at Manne Research Institute will need a PRS user account to register a study and report results on ClinicalTrials.gov. To request a PRS account, complete the PRS Account Request Form below.
For guidance on how to register studies and report results to ClinicalTrials.gov, visit the PRS Guided Tutorials to review training guides.
CT.gov Reporting Timelines & Due Dates
For information regarding when initial registration, updates, and results are expected to be reported to CT.gov, visit the CT.gov Reporting Due Dates Guide.
Frequently Asked Questions
