Regulation

The Duke Preclinical Translational Research Unit both institutes and adheres to strict regulations governing the research work conducted both inside and outside Duke.

We support and engage in regulatory compliance as early as possible to ensure a smooth translation to clinical trials.

We assist investigators with navigation of the following regulations:

  • FDA
  • IACUC
  • IRB
  • Clinical trials regulations

Our services ensure that the data collected will be both standardized and of the highest quality needed to meet publications and funding body requirements.

In addition, we employ skilled technicians to conduct our services. The data from those services is collected in accordance with the highest standards of GLP.

The Duke Preclinical Translational Research Unit maintains records of all original data produced to assist PIs in future analysis and investigations, in keeping with regulations.

To learn more about our regulation adherence, as well as guidelines self-directed by the Duke Preclinical Translational Research Unit, contact us.

For more information about how we develop our guidelines and the standards to which we adhere please visit the Duke Office of Regulatory Affairs and the Duke School of Medicine Office of Regulatory Affairs and Quality.