The Regulatory Services department was officially
formed at DCRI in June 2002. Before then, the group was part
of the Quality Assurance and Regulatory Affairs department.
The group's combined regulatory experience totals more than
27 years.
- Regulatory resource for DCRI and Duke University investigators
- Filing and maintenance of investigator-initiated INDs/IDEs
- Informed consent review for compliance with ICH and HIPAA
requirements
- Protocol review
- Safety reporting to regulatory authorities (U.S. and
international)
- New project consultation
- Training
- Clinical Study Report writing
For more information about our Regulatory Services, please
contact Bunny Donohue.
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