The CTSI offers regulatory support and assistance navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications. Registrations and support services are provided by our IND/IDE Navigator, Issis Kelly Pumarol, MD.
Available services include:
- Providing a centralized resource of information and support related to addressing regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies under investigator-sponsored INDs and IDEs
- Assisting WFBMC researchers in the preparation or review of initial IND or IDE applications, annual progress reports and preparing responses to the FDA
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IND Forms and Instructions
Used only for IND studies: This form must accompany the initial IND submission. It will contain serial number 0000 for the initial submission. This form is required to accompany all subsequent submissions to the IND. The serial number should be adjusted with each submission (i.e. 0000, 0001, 0002, etc.).
Key components of the FDA Form 1571:
- Contractual agreement between sponsor and FDA
- Name of person responsible for conduct and progress of the study (Item 14)
- Name of person responsible for the review and evaluation of safety information on the drug (Item 15)
- Sponsor agrees to conduct investigation in accordance with all applicable regulatory requirements (Item 16)
Used only for IND studies: This form should accompany the initial IND submission. If multicenter, each site should have its own 1572. NOTE: Anyone performing clinical assessments should go on the 1572. This may include physician assistants, nurse practitioners, etc.
Key components of the FDA Form 1572:
- Contractual agreement between an Investigator and the Sponsor
- Name of person responsible for conduct an investigation and their credentials
- Listing of the facilities and labs that are participating in the investigation
- Listing of the IRB responsible for reviewing/approving study
- Listing of additional Sub-Investigators
- Investigator agrees to conduct investigation in accordance with all applicable regulatory requirements (Item 9 - Commitments)
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from North Carolina Institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel Hill, Duke University, Wake Forest School of Medicine and RTI International.