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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.
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)
- 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: firstname.lastname@example.org 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 email@example.com or Shirley Marshall at firstname.lastname@example.org. For GMH’s budgetary requirements contact David Noble at email@example.com or firstname.lastname@example.org.
For more information, visit either the webite below:
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
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.
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.
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.