OCR Submission FAQs
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If your study has any billable items or services from Emory Healthcare or Grady, a coverage analysis is required. The study must also be submitted to OCR using the clinical research electronic form (OCR CR eForm). If the study has non-federal or internal funding, OCR can help with budget development and negotiation if needed. To request assistance, contact us at OCR@Emory.edu.
OCR recommends submitting the required pre-award documents while compiling the IRB and GCRC submissions and completing the checklists required by Emory Healthcare (EHC). The goal is to complete all these processes simultaneously in one sitting to expedite study approval.
OCR recommends submitting the required pre-award documents while compiling the IRB and GCRC submissions and completing the checklists required by Emory Healthcare (EHC). The goal is to complete all these processes simultaneously in one sitting to expedite study approval.
- Determine how the trial will be operationalized. Identify where procedures will occur and who will perform them since this can significantly impact CA and budget development.
- Complete the OCR CR eForm by answering the preliminary questions and attach the following documents:
- Final protocol
- IDE or IND number (if applicable)
- Tracked Changes or Summary of Changes of Protocol and ICD (if Amendment)
- Emory Draft Consent Form or Sponsor Version and EU Checklist
- Draft Clinical Trial Agreement or Award Letter
- Editable Sponsor Budget
- Provide other documents that may be available, such as:
- Draft Budget Prepared by Department
- GCRC/ACTSI Budget/Cost Analysis
- Investigator Brochure and/or Pharmacy Manual
- IND/IDE Exemption Letter
- Lab Manual
- EHC Device Form
- Grady OGA Financial Clearance Form
- Children's LOI Budget
- Investigational Drug Services (IDS) Data Sheet
- CRC/Data Manager Effort
- Miscellaneous Documents
- Radiology Budget with Radiology Fee and Authorized User Fee (if Nuclear Medicine)
3. If you are working with an affiliated or external site, contact the following for assistance:
- Atlanta Veteran’s Administration Medical Center (AVAMC): For assistance with AVAMC submission and more, please contact E. Clayton Carruth, Clinical Studies Center Manager, at edwin.carruth@va.gov or visit the Atlanta VA Research website.
- Children’s Healthcare of Atlanta (CHOA): For Childrens, please submit the documents needed for OCR submission to the Department of Pediatrics Research Administration Services (RAS) unit. The submission must be made to Children's using the "Intent to Submit Form (PRISM)" before being submitted to OCR.
- Georgia CTSA Clinical Research Centers: If you need help with CRN submission or other tasks (i.e., nursing services, Bionutrition, etc.), contact Turner Price at gcrc@emory.edu or visit the Georgia CTSA website.
- Grady Memorial Hospital (GMH): For assistance with study start-up processes, contact Naquia Mitchell, Associate Director for Emory at Grady (naquia.mitchell@emory.edu), Chad Anderson, Director for Grady Research Administration (canderson@gmh.edu) or Shirley Marshall, Research Administration Specialist for Grady Research Administration (smarshall@gmh.edu). Visit the Grady Office of Research Administrationwebsite.
If a clinical research protocol is amended and billable items or services change, requiring a revision to the coverage analysis, the amendment must be submitted to OCR for review and/or revision using the the clinical research electronic form (OCR CR eForm).
Email all required documents to OCR@Emory.edu if the study has federal or internal funding, or send the documents to your RAS unit so they can submit the study documents in EPEX if your research has external non-federal funding. The required documents should be tracked changes if available:- The clinical research electronic form (OCR CR eForm)
- Protocol
- Draft Informed Consent - Emory or sponsor draft with EU checklist
- Draft Budget
- Draft Clinical Trial Agreement (CTA) or contract/award if funding already awarded
If you are uncertain, please contact us at OCR@Emory.edu for a preliminary review and confirmation of your amendment.
A Lead Clinical Research Finance Manager (LCRFM) will review the study documents. They may contact you to ask how you plan to operationalize the study to get a clearer picture of the billable items and services. The LCRFM creates a draft coverage analysis that outlines which billable items and services are to be billed to third-party payers and which are billed to the study per Medicare guidelines. Billable items and services are those EHC items and services billed with CPT codes and can include physical exams, labs, and scans. The PI will be sent the coverage analysis for review and approval before the budget is developed. Items like follow-up phone calls, patient questionnaires, and other non-billables will not be included in the coverage analysis but will be included in the study budget.
The draft budget is developed for non-federally funded and unfunded studies and will be sent to the study team for review and approval. Once the study team approves the budget, OCR will contact the sponsor/CRO for negotiable studies. Study teams can develop and negotiate their budgets, but it is not recommended. OCR has extensive experience with budget development and negotiation, as well as relationships with sponsors to facilitate the development of budgets that cover study costs.
The LCRFM will also develop Letter-of-Intent (LOI) budgets for PIs who want to contact the industry sponsor for funding for their prospective PI-initiated studies. The PI should submit a draft protocol or study summary to OCR that outlines the study items and services.
If the study only requires budget development, a Senior Clinical Research Finance Manager (SCRFM) will work with the study team to develop and negotiate a budget that covers cost.
For federally funded studies that have already been awarded funds or are seeking federal funding, OCR will still need to develop a coverage analysis, and your RAS unit will work with you on the budget.
The draft budget is developed for non-federally funded and unfunded studies and will be sent to the study team for review and approval. Once the study team approves the budget, OCR will contact the sponsor/CRO for negotiable studies. Study teams can develop and negotiate their budgets, but it is not recommended. OCR has extensive experience with budget development and negotiation, as well as relationships with sponsors to facilitate the development of budgets that cover study costs.
The LCRFM will also develop Letter-of-Intent (LOI) budgets for PIs who want to contact the industry sponsor for funding for their prospective PI-initiated studies. The PI should submit a draft protocol or study summary to OCR that outlines the study items and services.
If the study only requires budget development, a Senior Clinical Research Finance Manager (SCRFM) will work with the study team to develop and negotiate a budget that covers cost.
For federally funded studies that have already been awarded funds or are seeking federal funding, OCR will still need to develop a coverage analysis, and your RAS unit will work with you on the budget.
If the study does not require a CA and budget development but meets the NIH clinical trial definition, complete the following:
- Submit the OCR CR eForm and click "Bypass Preliminary Questions."
- For Submission Form, select "Clinical Trials Activation ONLY."
- Enable EML or Radiology Forms, if applicable, by selecting "Yes.
Research Fees
The fee schedule and other financial information contained on this website is sensitive, proprietary, and confidential information that is not to be used except for the express purpose of budget development for Emory research studies and shall not be shared with any unauthorized person employed by Emory University or Emory Healthcare and not with any third party whatsoever.
University Standard Research Study Fee Memo (7.18.2022)
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