Education

The Office of Research Integrity and Compliance (ORIC) provides educational resources for the Emory research community. Training regarding FDA regulations and sponsor-investigator (S-I) responsibilities is provided individually and through educational presentations to investigators and research study staff.

Below are materials that have been presented in previous educational presentations.

• Charging for Investigational Drugs in Clinical Trial and in Expanded Access (PDF)
• Dietary Supplements and IND (PDF)
• Humanitarian Use Device and Humanitarian Device Exemption (PDF)
• Institutional Review Board Responsibilities in Making the Significant Risk and Non-Significant Risk Device Determination (PDF)
• Investigator Device Exemption (IDE) Overview (PDF)
• Sponsor-Investigator Drug Safety Reporting (PDF)
• Sponsor/Investigator Responsibilities (PDF)

Past Presentations

• Audits in Clinical Trials: Avoiding the Pitfalls (PDF) (Kris West)
• Charging for Investigational Drugs in Clinical Trials (PDF)
• Consent Decrees (PDF)
• Informed Consent issues (PDF) (Kris West)
• Informed Consent: Process and Documentation (PDF) (Margaret Huber and Shara Karlebach)
• Crossing the Line: When Does Innovative Therapy become Research (PDF) (Kris West)
• Informed Consent-It's not just a document (PDF) (Kris West and Margaret Huber)
• Monitoring Plans (PDF) (Margaret Huber)
• PI Responsibilities (PDF) (Carlton Dampier)
• S-I Responsibilities (PDF) (Margaret Huber)

Contact Us

If you have any questions or would like to discuss topics related to FDA-regulated studies, please contact us at ORIC Emory.