The Ophthalmology CRU will:
- Develop clinical research budgets*
- Contact collaborating groups (i.e., Radiology, IDS Pharmacy, DCRU, BIAC, etc.) for costs/fees associated with the study.
- Work with the Principal Investigator (PI)/Study Coordinator for approval of the budget prior to sending the budget to the sponsor for negotiation.
- Negotiate the budget with the sponsor.
*The budget will be developed based on the consent form, final protocol and study manual(s). These documents are sent, along with any other study information, to Ali Gill (firstname.lastname@example.org).
The Principal Investigator (PI)/Study Coordinator will:
- Review and approve the budget prior to the Ophthalmology CRU sending the budget to the sponsor for negotiation.
- Ensure procedures and tests are "billed" correctly:
- Standard of care/Routine care = insurance
- Study-specific = grant
If, upon preliminary review, the Duke Office of Clinical Research (DOCR) determines a study to have billing risk, an initiation meeting with the study team will be arranged through DOCR and the Ophthalmology CRU.
The meeting will be to:
- Determine the need for a billing calendar
- Develop a research charge router
A member of the DOCR team will contact the study team to schedule the meeting.
In preparation for the meeting, the Ophthalmology CRU, in conjunction with the study team, will forward the required/requested documents to DOCR. NOTE: If the study is supported by a grant [see Grants and Contracts}, the Ophthalmology CRU will work with the assigned Grant Specialist to develop a budget and/or obtain costs of procedures and tests involved in the study.
If the study is supported by a grant (see Grants and Contracts), the Ophthalmology CRU will work with the assigned Grant Specialist to develop a budget and/or obtain costs of procedures and tests involved in the study.