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The Office of Research Compliance is committed to providing education and consultation regarding regulatory requirements,
compliance obligations, and best practices. |
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Billing & Audit
ORC provides compliance review of billing processes associated with clinical trials in order to assure that they
conform to the appropriate federal and state regulations. |
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For specific billing process information, click here to access the
webpage of Emory's Office for Clinical Research. |
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FDA regulated Device & Drug Studies |
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ORC provides compliance consultation in order to assure that investigators conform to applicable regulations. Examples include:
- FDA inspections
- IND and IDE submissions
- Investigator-initiated trial development
Update: THE FDA HAS POSTED NEW GUIDANCE ON INVESTIGATOR RESPONSIBILITIES REGARDING STUDY SUBJECT PROTECTION. For more information click here.
Update: NEW RULE ABOUT CHARGING FOR INVESTIGATIONAL DRUGS IN CLINICAL TRIALS AND IN EXPANDED ACCESS USE. For more information click here.
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Resources |
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Guidelines for an FDA Inspection |
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External Resources |
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Audit preparation checklist
Food and Drug Administration (FDA)
FDA Draft Guidance FAQs on Form 1572 |
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