Do you have an upcoming project that requires regulatory support? ORAQ can provide regulatory cost estimates, letters of support, and preliminary regulatory assessments for proposals.
Costs
An initial regulatory consultation with ORAQ is offered free of charge for all Duke-sponsored projects.
ORAQ is currently revising its charge criteria and cost recovery model for regulatory affairs services. Therefore, ORAQ recommends that researchers include funding for regulatory support in the budget for any Duke-sponsored project that is anticipated to require ORAQ services. ORAQ can work with study teams to develop estimated regulatory support costs that may be incorporated into grant applications, contracts, or other funding proposals.
To request a cost estimate for regulatory affairs support, please complete our Regulatory Affairs Service Request Form and select “Cost Estimate for ORAQ Regulatory Support” as the “Purpose of the Regulatory Service Request”. If the cost estimate will be included in a proposal, please note you will need to provide the SPS number for the proposal and a copy of your research strategy in the survey.
If you have already submitted a Regulatory Affairs Service Request Form for this project previously, please reach out to your assigned Regulatory Affairs Scientist directly to request the cost estimate. If applicable, provide the SPS number, research summary, name of funding agency or financial sponsor, and the submission deadline for the proposal.
Please note: Submission of a cost estimate request does not guarantee future pricing. Final costs and chargeable services will be determined based on ORAQ's approved charge criteria and the scope of support required at the time services are provided.
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 (Duke login required for access) that can be downloaded and modified to describe your research proposal. To request a letter of support from ORAQ, please complete our Regulatory Affairs Service Request Form and select “Letter of Support for Proposal” as the “Purpose of the Regulatory Service Request”. Please note you will need to provide the SPS number for the proposal and a copy of your research strategy in the survey.
If you have already submitted a Regulatory Affairs Service Request Form for this project previously, please reach out to your assigned Regulatory Affairs Scientist directly to request the letter of support. Please provide the SPS number, research summary, name of funding agency or financial sponsor, and the submission deadline for the proposal.
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. Please note that in the absence of FDA feedback, the Duke Health Institutional Review Board makes the final determination on whether a study requires FDA oversight after a study is submitted in iRIS. To aid in the development of this letter, ORAQ has developed a template (Duke login required for access) that can be downloaded and modified to describe your research proposal. To request a preliminary regulatory assessment, please complete our Regulatory Service Request Form select “Preliminary Regulatory Assessment for Proposal” as the “Purpose of the Regulatory Service Request”. Please note you will need to provide the SPS number for the proposal and a copy of your research strategy in the survey.
If you have already submitted a Regulatory Affairs Service Request Form for this project previously, please reach out to your assigned Regulatory Affairs Scientist directly to request the preliminary regulatory assessment. Please provide the SPS number, research summary, name of funding agency or financial sponsor, and the submission deadline for the proposal.
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.