Cost Estimates
ORAQ regulatory support is provided free of charge for most Duke-sponsored projects. However, ORAQ may require funding support when the work meets one of the following criteria:
- Regulatory Affairs Support for “Commercial” Activities—Effort to support an investigational application where the product under investigation is intended to be commercialized at a later date, an FDA marketing application, or modification of an FDA-cleared/approved product.
- Regulatory Affairs Support for Coordinating Center Role—Effort to support large, multi-center studies or projects that require use of a coordinating center.
- Regulatory Affairs Support for Multi-Project Programs—Effort to support large, multi-project research activities, such as Program Project/Center Grants (P series), Cooperative Agreements (U01), or projects of similar magnitude.
If the needed regulatory work meets one of the criteria above, we can work with you to develop a budget of estimated costs that can be included in a grant or contract negotiation. To request a cost estimate for regulatory affairs support, please email ORAQ@duke.edu with “Request for Cost Estimate” in the subject line.
Letter of Support
ORAQ can provide a letter of support demonstrating our commitment to provide regulatory support throughout the research project period. To aid in the development of this letter, ORAQ has developed a template that can be downloaded and modified to describe your research proposal. Please draft the letter and email a Word version to ORAQ@duke.edu with "Request for Letter of Support" in the subject line. Be sure to include in the body of the email:
- The investigator name and department
- The relevant sponsor/program
- The SPS number for the proposal
- A copy of your research strategy and other relevant documents
- The deadline to the sponsor/your send date
- The name and email address of the person(s) to contact when the letter is executed
- Special formatting requirements (e.g., length, font size)
ORAQ will review the draft letter and make any edits before printing on letterhead and returning a signed copy. While execution of the letter will be completed as quickly as possible, please expect that it may take up to 2-4 business days.
Preliminary Regulatory Assessments
It is becoming increasingly common for funding opportunities and Agencies to require a regulatory plan/assessment for proposals that include use of investigational products in human subjects (e.g., clinical research and clinical trials). ORAQ can provide a preliminary regulatory assessment of whether the study is subject to FDA oversight and if an IND or IDE application may be needed. Although the Duke Health Institutional Review Board makes the final determination on whether a study requires FDA oversight after a study is submitted in iRIS, ORAQ can provide documentation of an initial evaluation. To aid in the development of this letter, ORAQ has developed a template that can be downloaded and modified to describe your research proposal. Please draft the letter and email a Word version to ORAQ@duke.edu with "Request for Regulatory Assessment" in the subject line. Be sure to include in the body of the email:
- The investigator name and department
- The relevant sponsor/program
- The SPS number for the proposal
- A copy of your research strategy and other relevant documents
- The deadline to the sponsor/your send date
- The name and email address of the person(s) to contact when the letter is executed
- Special formatting requirements (e.g., length, font size)
ORAQ will review the research strategy and draft letter and make any edits before printing on letterhead and returning a signed copy. While review of the research strategy and execution of the letter will be completed as quickly as possible, please expect that it may take up to 10 business days.