Regulatory and Compliance
The Office of Research Compliance (ORC) is committed to the development of a Research Compliance Program that includes distribution of written policies, procedures, and standards of conduct that promote adherence to applicable federal and Georgia State laws, regulations and institutional policies.
For complete information, please visit CHOA Research .
Office of Research Compliance
Children’s Healthcare of Atlanta
1687 Tullie Circle
Atlanta, GA 30084
The Emory Clinical Trials Audit and Compliance (CTAC) office works to ensure compliance in clinical trials at Emory by:
Reviewing the conduct of clinincal trials for compliance with federal regulations, Good Clinical Practice (GCP), sponsor requirements, and Institutional policies.
Educating study teams on best practices as part of GCP to meet federal regulatory requirements.
Providing tools, such as delegation of authority logs and study checklists, to study teams to enhance documentation of compliance.
Advising and consulting study teams based on specific needs of a clinical trial or clinical department at Emory.
For complete information, please visit Emory CTAC .
1599 Clifton Rd.
Suites 5.104 and 5.105
Atlanta, GA 30322
Phone (404) 712-5159
Fax (404) 712-8580
Emory Office of Compliance
The Emory Office of Compliance is committed to helping ensure that Emory University’s activities adhere to the highest legal, professional, and ethical standards. The Office of Compliance assists University units in complying with the laws, regulations and policies that govern institutions of research and higher education through education; assessment; assistance with policy and process development; auditing; and monitoring.
For complete information, please visit the Emory Office of Compliance website.
Trust Line for Compliance Concerns (toll free) 1-888-550-8850
Office of Compliance
1599 Clifton Road, NE, 4TH Floor
Atlanta, GA 30322
Phone: (404) 727-2398
FAX: (404) 727-2328
CHOA Conflict of Interest Office
Individual interests may present real or perceived risks to the welfare and rights to human subject research and the integrity of the research at Children's Healthcare of Atlanta. Full disclosure and openness of potential and actual conflicts of interest (both financial and non-financial) must be reported, reviewed and managed.
For complete information, please visit the CHOA COI.
Emory Conflict of Interest Office
The Conflict of Interest Review Office provides oversight, systemic safeguards, and regulatory expertise in managing individual and institutional financial interests that could impact research and scholarly activities. In doing so, we support Emory investigators and scholars in maintaining integrity in their research efforts.
For complete information, please visit the Emory COI website.
Conflict of Interest Review Office
1599 Clifton Road
6th Floor East
Atlanta, GA 30322
The Center for Clinical and Translational Research (CCTR) will provide guidance and assistance in navigating FDA regulation for pediatric Investigational New Drug (IND) applications.
Assistance will be supported within the following areas. To request assistance, please click here
- Do I need to submit an IND?
- What’s needed to submit an IND?
- Overview of the IND process
Pre-IND Meeting (if required)
- Form templates
- Textual development of the application
- Guidance on packaging and shipping
IND Maintenance- Guidance and templates are available for:
- Protocol Amendments
- Annual Reports
- Safety Reports
EML Reference Ranges (see "Quick Links" on right)
|EG and Lab Certifications|
|Investigational Drug Services||Director, CV, License, and SOPs||Director, CV, License, and SOPs|
|Institutional Review Board||Compliance and Registration|
|IRB Meeting Schedule|
Research Study Templates-Clinical Trials Tools