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Always work with your Research Administration Services (RAS) unit before submitting 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 requires OCR submission for a PRA and budget development, please follow the steps below:
Before submitting to OCR, it is recommended that some preliminary work is completed to make the transition process as smooth as possible, as well as to expedite turnaround time:
- Obtain a protocol, contract template, budget, IDE or IND number (if applicable).
- Submit to Emory IRB and obtain, at minimum, an IRB #.
- Determine how the trial will be operationalized. Identify where procedures will take place since this can have a significant impact on how the PRA and budget are developed.
- If the trial has radiology procedures, submit to radiology for review just prior to OCR submission by completing the Radiology Research Checklist.
- If the research study will use one of the CRN sites, submit the initial application with the other documents. Or, if you have CRN/ACTSI approval, provide their letter of support.
Additionally, it may be helpful to contact affiliated sites if subjects are enrolled at any of the following sites:
OCR recommends submission of the pre-award paperwork in tandem (during the same period of time) with putting together the IRB submission, CRN 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.
- OCR Submission Form - All items must be filled out completely for both initial and amendment submissions
- Protocol - final version, draft protocols cannot be accepted
- Draft Informed Consent (Emory draft required)
- Draft Clinical Trial Agreement (CTA) or contract/Award (if Federal funding)
- Draft Budget Template
- Investigator Effort calculation
- 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 budget grid from CHOA’s CTO which accompanies the BAF (Budget Approval Form)
A Lead Clinical Research Finance Manager (CRFM) or Manager will do a preliminary review of the paperwork. They may contact you to ask questions about how you plan to operationalize the study to get a clear picture of the billable items and services. The Lead CRFM will review all the documents in detail and create a draft PRA which determines the appropriate CPT codes for any billable items that need to be paid by grant funds. The PI will need to review and approve the PRA before the budget can be developed. The PRAs are to be used as a billing tool, not as the study schema. Items like blinded ratings, patient questionnaires, detailed central lab info, and other non-billables may not be included in the PRA. If the study only requires budget development, a Senior Clinical Research Finance Manager (Sr. CRFM) will work with you to develop a budget that covers cost.
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) or if there is an addition of billable items or services and the initial protocol was ongoing after June 11, 2007, then the amendment will need to be submitted to OCR for review and/or the revision of the PRA.
If you are uncertain, please contact us at OCR@Emory.edu for a preliminary review and confirmation of your amendment.
If the budget has not been previously negotiated, and the study team agrees that the PRA captures all applicable items and services and approves the PRA, OCR will create a draft budget. The draft budget is developed for non-federally funded studies and will be sent to the study team for review and input. Once the study team approves the budget, OCR will contact the sponsor/CRO and negotiate the budget. If you would prefer to negotiate the budget yourself, that is allowed per Emory, but not recommended. OCR specializes in creating budgets and has historical data and documentation to justify fees.
If this is a federally funded study, OCR will not create a budget for you. If funding has already been received, once the PRA has been reviewed and approved we will complete our process with you and forward documents to our Data Integrity team so they can activate your study in ERMS once you have received IRB approval and a smart key account is available to cover items and services.
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.