About Regulatory Affairs
Contact Us
Regulatory Resources
Slide Presentations
Investigator INDs Best Practices
Workshop: Sponsor-Investigator IDEs Best Practices: Preparation and Maintenance: October 30, 2009

The mission of DTMI Regulatory Affairs is to support the investigator community in developing regulatory and clinical strategy and fulfilling regulatory requirements for clinical research programs along the continuum of translational, clinical, and community research.

Services we offer:

The DTMI Regulatory Affairs Team offers regulatory advice to investigators in all aspects of research from preclinical requirements to first-in-human studies and beyond…

Strategic Program Development

• Identify regulatory risk-benefit

• Develop strategies for complex issues with potential for significant regulatory compliance impact

• Guide strategies for program development

IND/IDE Preparation and Maintenance

• Assist with scheduling, coordinating, preparing, and attending meetings with the FDA

• Assist with IND/IDE preparation and submission, including IND electronic submissions

• Provide full preparation and submission of IND “exempt” applications

• Assist with IND annual reports and other regulatory submissions

Program Maintenance and Support

• Assist investigators in determining the regulatory requirements that might apply to their research

• Provide guidance on whether an IND/IDE is required for a particular situation

• Consult on preclinical studies required prior to submission of an IND/IDE

• Determine applicability of GLP and GMP requirements in anticipation of a future IND/IDE submission

• Anticipate regulatory and related obstacles

• Interface with regulatory authorities

• Identify appropriate resources for addressing regulatory issues

• Facilitate collaborative interactions between investigators and other stakeholders and institutional resources

• Assist with the development of intradepartmental strategies and polices related to IND/IDE processes

• Provide a portal for regulatory questions and resources

• Regulatory “help desk” at regulatorydtmi@mc.duke.edu

• Resources available online at http://www.dtmi.duke.edu/core-teams/regulatory/best-practices

Education

• Provide training and education on regulatory issues and requirements (e.g. IND/IDE preparation and submission, development of internal monitoring programs)

• Provide consultative services with regard to the design and delivery of continuing education programs related to regulatory requirements GCP/GLP/GMP

• Provide individualized Regulatory Affairs internships