The Office of Research Compliance (ORC) offers education and consultation services regarding regulatory requirements, compliance obligations, and best practices with particular support for investigator-initiated trial development. In addition, information is posted on ORC’s website about resources for Drug and Device studies along with Educational Presentations and FDA website links under FDA Regulated Studies. The Office of Research Compliance website is www.orc.emory.edu. In the Sponsor Investigators section, you will find information along with many forms & tools which Sponsor-Investigators are encouraged to use as templates.
If you have questions or would like to discuss topics related to FDA regulated studies or sponsor-investigators, please contact us at (404) 727-2398 or ORC@emory.edu.