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ORAQ Regulatory Affairs Service Request

Please complete the survey below.

Thank you!

Sponsor First Name

Sponsor Last Name

Sponsor Credentials

Sponsor E-mail

Is the project sponsored by a non-Duke institution, company, or individual?

Yes No

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Duke Unique ID

If non-Duke sponsor is an individual, list their affiliation (institution or company) here.

Please ensure that a Duke collaborator is listed as either a Secondary or Alternative Contact. For "Department associated with project", please select the department, center, or institute associated with the Duke collaborator, if known.

Department associated with project

School of Medicine

Trinity College of Arts and Science

Pratt School of Engineering

Duke University Health System (DUHS)

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School of Medicine

Trinity College of Arts and Science

Pratt School of Engineering

Product Type

Drug

Biologic

Medical device

Tobacco

Combination product

Unsure

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Product Name or Short Description

Indication(s)

Is there a regulatory application associated with this project?

Yes No

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Is a Duke-faculty member the sponsor of the regulatory application?

Yes No

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Select Application Type

Investigational New Drug (IND)

Investigational Device Exemption (IDE)

Investigational Tobacco Product (ITP)

Master File (MF)

Orphan Drug Designation (ODD)

Health Canada Clinical Trial Application (CTA)

Biologics License Application (BLA)

Emergency Use Authorization (EUA)

Device Emergency Use or Compassionate Use Request

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Application Number

Secondary Contact Name

Secondary Contact E-mail

Alternative Contact Name

Alternative Contact E-mail

Purpose of Regulatory Service Request

Document Review and Submission

Document Preparation

Strategic Development

Initial Consultation

Letter of Support for Proposal

Cost Estimate for ORAQ Regulatory Support

Preliminary Regulatory Assessment for Proposal

Other

SPS Number

Funding Agency or Financial Sponsor for this Proposal

Submission Deadline for this Proposal

M-D-Y

Please upload a copy of the research strategy for the proposal and other relevant documents into the file upload below.

Describe any special formatting requirements for the Letter of Support (e.g. length, font size)

Please download this Letter of Support template and modify it to describe your research proposal. Upload a Word version of your modified Letter of Support in the file upload field below.

Attachment:LOS Template Website_30AUG2022.docx

ORAQ will review the draft Letter of Support and make any edits before printing on letterhead and returning a signed copy over e-mail. While execution of the letter will be completed as quickly as possible, please expect that it may take up to 2-4 business days.

Describe any special formatting requirements for the Preliminary Regulatory Assessment (e.g. length, font size)

Please download this Regulatory Assessment Letter template and modify it to describe your research proposal. Upload a Word version of your modified letter in the file upload field below.

Attachment:Regulatory Assessment Letter_Template_30AUG2022_0.docx

ORAQ will review the research strategy and draft letter and make any edits before printing on letterhead and returning a signed copy over e-mail. 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.

If you have already been in contact with an ORAQ team member about this project, please select their name from the following list.

Brief Description of Request

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Please upload any files relevant to your service request, such as a protocol or protocol synopsis, publication, relevant sections from a grant application (e.g., abstract, specific aims, research summary), or product description. If you are requesting proposal support (letter of support, cost estimate, or preliminary regulatory assessment), you must provide the research strategy for the proposal.

Upload file

ORAQ regulatory support is provided free of charge for most Duke-sponsored projects. However, ORAQ may require funding support when the work meets certain criteria set by the School of Medicine. All projects can have initial consultations with ORAQ free of charge. These questions are for assessing whether funding may be needed for longer term ORAQ support of the project. Please include any additional relevant information regarding your plans for funding or commercialization to the Description of Request box above. For more information, please visit the ORAQ webpage.

Could this product potentially be commercialized or licensed at a later date?

Yes No Not Sure

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Will this project involve a multi-center clinical study or require use of a coordinating center?

Yes No Not Sure

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Will the funding for this project come from a large, multi-project grant like Program Project/Center Grants (P series), Cooperative Agreements (U01), or projects of similar magnitude?

Yes No Not Sure

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Upload file

Was this taken as a survey? (Hidden on forms and surveys)

Yes

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