OCR Submission

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When do I submit to OCR?

Review the OCR Decision Tree to determine if your study requires OCR submission for either a Prospective Reimbursement Analysis (PRA), budget development, ClinicalTrials.gov, and OCR Invoicing. If your study has any billable items or services from Emory Healthcare or Grady a PRA is required and the study needs to be submitted to OCR. If the study has non-federal or internal funding, OCR can help with budget development and negotiation if needed. 

OCR recommends submission of the pre-award required documents while also putting together the IRB submission, GCRC submission, and completing the various checklists required by EHC.  To expedite turnaround for study approval, the goal is that all these processes are completed around the same time.

What are the steps for an OCR submission for PRA and/or budget development?

1.  Obtain a final protocol, IDE or IND number (if applicable), informed consent and contract/budget template from the sponsor if external funding.

2.  Submit to Emory IRB and obtain, at minimum, an IRB #.eIRB login.

3.  Determine how the trial will be operationalized. Identify where procedures will take place and who will perform them since this can have a significant impact on PRA and budget development.

4.  If the trial has radiology procedures, submit to radiology before the OCR submission by completing the Radiology Research Checklist.

5.  If the research study will use one of the GCRC sites, submit the initial application with the other documents. Or, if you have GCRC ACTSI approval, provide their letter of support.

6.  Email all appropriate documents to OCR@Emory.edu if the study has federal or internal funding, or send the documents to your RAS so they can submit the study documents in EPEX if your study has external non-federal funding.  The required documents are:  

  • OCR Submission Form - Please fill out all fields.
  • Protocol  - final version
  • Draft Informed Consent (Emory or sponsor draft with Emory checklist)
  • Draft Budget Template
  • Draft Clinical Trial Agreement (CTA) or contract/Award (if funding already awarded)
  • Investigator Effort calculation form
  • Most recent FDA communications, e.g., IND letter that includes IND number, IDE letter that includes IDE number and category assignment
  • If using any CHOA services, submit the LOI and budget from CHOA's CTO.

Additionally, it may be helpful to contact affiliated sites if subjects are enrolled at any of the following sites:
  • Atlanta Veteran’s Administration Medical Center (AVAMC)

For assistance with AVAMC submission and more, please contact Jane Guidot, Clinical Studies Center Manager: jane.guidot@va.gov  or visit their website at Atlanta VA Healthcare System.

  • Children’s Healthcare of Atlanta (CHOA)

For Children's, please submit documents needed for OCR submission to the Department of Pediatrics Research Administration Services (RAS) unit.  Submission must be submitted to Children's using the "Intent to Submit Form (PRISM)" before submitting to OCR. 

  • Georgia CTSA Clinical Research Centers

For assistance with CRN submission and more, please contact Debora Clem, Sr. Associate Director of Programs: dclem@emory.edu or visit their website at http://georgiactsa.org/discovery/protocol-submission.html.

  • Grady Memorial Hospital (GMH)

For assistance for study start-up processes, contact Chad Anderson at canderson@gmh.edu or Shirley Marshall at smarshall@gmh.edu.  For GMH’s budgetary requirements contact David Noble at dnoble@gmh.edu or grants@gmh.edu.   

For more information, visit either the webite below:

What if my study has an amendment, will OCR submission be required?

If a clinical research protocol is amended and there is a change to billable items or services which requires a revision to the Prospective Reimbursement Analysis (PRA) the amendment will need to be submitted to OCR for review and/or the revision of the PRA.

Email all required documents to OCR@Emory.edu if the study has federal or internal funding, or send the documents to your RAS so they can submit the study documents in EPEX if your study has external non-federal funding.  The required documents should be tracked changes if available:
    1. OCR Submission Form – please fill out all fields
    2. Protocol
    3.  Draft Informed Consent - Emory or sponsor draft with Emory checklist
    4.  Draft budget
    5.  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.

Who develops the PRA and develops/negotiates my study budget?

A Lead Clinical Research Finance Manager (LCRFM) will review of the study documents, and may contact you to ask questions about how you plan to operationalize the study to get a clearer picture of the billable items and services.  The LCRFM create a draft PRA which outlines which billable items and services are to the 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 PRA 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 PRA, 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 those studies that are negotiable.  Study teams can develop and negotiate their own budgets, but it is not recommended.  OCR has extensive experience with budget development and negotiation, as well as relationships with sponsors to facilitate development of budgets that cover study costs. 

The LCRFM will also develop Letter-of-Intent (LOI) budgets for PIs who want to reach out to industry for funding for their prospective PI-initiated studies.  The PI should submit to OCR a draft protocol or study summary 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 those federally funded studies that have already been awarded funds or are going after federal funding, OCR will still need to develop a PRA, and your RAS will work with you on the budget.

What happens if my study does not require a PRA or budget development?

If the study does not require a PRA and budget development but it meets the NIH definition of a clinical trial, you will need to submit a Request for Clinical Trial Activation in ERMS for Subject Enrollment Notification ONLY so it is activated in ERMS. Please note that the study team is required to fax or email in the ERMS cover sheet and the ICF for all research subjects at Emory. Please review the ERMS page on the steps to follow in ERMS.

Note: If a study does not need a PRA when submitting the study in EPEX, be sure to check “no” to question #18.