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Submit reports and disclosures, and communicate with sponsors

Need assistance with reports, disclosures, or communicating with sponsors?

Reports and disclosures needed for research projects depend upon the research activities and funding support of the project. Utilize this page for guidance on developing and submitting these reports and disclosures, and communication with project sponsors. 

Communicating with sponsors

Throughout a project, there may be instances where communication with the sponsor (for funded research projects) is needed outside of regularly scheduled reports. Faculty may contact the program official to discuss matters related to the science or programmatic issues. Faculty and staff are NOT permitted to contact the sponsor for administrative issues. These issues must be addressed by authorized Duke representatives (e.g., ORA, ORS, ORC).
Examples of scientific or programmatic issues

The Program Officer (also referred to as the Program Manager) is a good resource to understand the funding interests of the sponsor and key points of their funding programs. It is generally best for the PI or delegate to send a brief introductory email and ask if there is a good time to set up a call to discuss your research goals and which of their programs are applicable or best fit your research idea.

Examples of scientific or programmatic communications include:

  • Describing your project idea
    • Ask if it is the type of project the sponsor funds

    • Ask about each specific aim and its relevance to the sponsor’s mission

    • Discuss the level of your pilot data for feedback

  • Asking about shortcomings/problems often seen in applications
    • What sorts of problems keep proposals from being funded?

    • How can you avoid those problems?

  • Asking about traits of successful proposals
    • Are there any areas/activities the agency would like to see represented in projects but which have been overlooked by other applicants?

  • Confirming proposal guidelines and funding priorities
    • Ask about any matters that were unclear or puzzling

    • Confirm the funding priorities and check for any changes

    • Who reviews the proposals?

    • How many people review the proposals?

    • How are reviewers chosen?

    • Can I suggest reviewers?

Examples of administrative issues

Faculty members should contact their grants and contracts administrator for administrative concerns on funded projects, and can access the Faculty Communication to External Sponsors on Administrative Issues policy for more information. These issues must be addressed by authorized Duke representatives (e.g., ORA, ORS, ORC).

Examples of administrative issues include:

  • Interpretation of sponsor policy or guidelines
  • Budget allowability
  • Appealing a rejection of an application
  • Appealing a sponsor’s decision to decrease budget categories for salary and personnel costs.
  • Submitting a request for a No Cost Extension
  • Requesting prior approval for adding a foreign component or a change in project personnel (such as PI Disengagement)
  • Program officer asks about unobligated balances or reductions in effort.
Communicating with Foundation Sponsors

Contact Foundation Relations First List

Administrative communication with certain sponsors is coordinated by the Office of Foundation Relations. Please contact the designated individual noted on this list, in lieu of reaching out directly to the sponsor. This pertains to pre-award and post-award actions, including, but not limited to, questions about allowable budget categories or indirect rate, request for budget revisions or end-date extensions, return of unspent funds, and approval of press releases. Although not required, faculty members are encouraged to alert the designated Foundation Relations representative when they communicate with these sponsors about prospective or on-going projects.

As-needed reports and disclosures

Emergency response and incident reporting

Protocols are in place for reporting various emergencies and incidents, including fires, personal injuries, and biological, chemical, and radiological exposures and spills.

Access the Duke Occupational Health and Safety website for specific guidance on response and reporting procedures.

Protocol deviations/violations, unanticipated risks, and adverse event reporting

Protocol deviations (an inadvertent act in which the protocol is not followed) and protocol violations (an intentional act in which the protocol is not followed) must be reported to the IRB if any of the following apply:

  • Affects subject rights and welfare
  • Affects subject safety
  • Affects the integrity of study data
  • Affects the subject's willingness to continue in the study

Is specifically requested by a government agency, internal/external auditor, medical monitor, or the IRB. Unanticipated risks or adverse events include any study-related unexpected events that may increase harm to a participant (a new risk, or an event occurring in greater frequency or intensity than expected) or result in a breach of confidentiality.

Protocol amendments

When amendments are needed to an IRB or IACUC approved protocol, a request must be submitted and approved before those changes to the research project can take place.

Access the Manage study and maintain institutional approval page for information about amending Campus IRB, DUHS IRB, and IACUC protocols.

Data transfer agreements or material transfer agreements

Any Duke researchers considering transferring or sharing research materials or human subjects data with outside collaborators must alert the Office of Research contracts.

Access the Navigate contracts and agreements page for more information.

Invention disclosures

If any inventions or new technologies arise from your research, an Invention Disclosure Form should be submitted to the Duke Office for Translation and Commercialization to begin the process of protecting your idea.

Other Support/Current and Pending

Investigators are required to disclose all resources, including financial, available in support of the individual’s research endeavor, whether the support originates from Federal and non-Federal (including foreign governments, state and local), commercial or institutional sources. If an investigator receives any new support (not disclosed during proposal submission or JIT), it must be disclosed to the institution and the sponsor. 

Access the Disclose activities (Other Support/Current and Pending) page for details, processes, and resources.

Routine reports and disclosures

Continuing renewal for IRB and IACUC protocols
  • For Campus IRB protocols, a Periodic Check-In Form must be submitted annually for the IRB to review and renew the protocol. For more information about continuing reviews and post-approval monitoring, access the Campus IRB website.
  • For DUHS IRB protocols, a continuing renewal must be submitted in iRIS 60 to 45 days prior to the protocol expiration date. Access the DUHS IRB website for more information about continuing reviews and protocol expirations.
  • For IACUC protocols, annual reviews are required for all previously approved, ongoing IACUC protocols that indicate use of a USDA regulated species or are supported with VA funds. Access the IACUC continuing review protocol guidance for more information.
Progress reports to sponsors

Sponsors generally require quarterly or annual reports to provide updates on the scientific progress and financial status of the project. Research teams should coordinate to complete progress reports to the sponsor. Requirements for the final report should be stated in the terms and conditions of the award or contract.

Progress reports often include disclosures of Other Support/Current and Pending. Access the Disclose Activities (Other Support/Current and Pending) page for details, processes, and resources.

Annual project reports should address progress in all activities of the project and should disclose activities such as international travel, participant support activities and other components as required by the award’s sponsor.

Outside activities (Conflict of Interest)

An annual outside activities disclosure form is required from all faculty and staff who participate in research at Duke to relay any potential conflicts of interest or conflicts of commitment. Outside activities disclosures should also be updated whenever there is change in status outside of the annual reporting period. Access the DOSI website for more information and access to the disclosure form.

View the status of your COI form and access your management plans from your profile in myRESEARCHhome.

Clinical Quality Management Plans

Studies that require a Clinical Quality Management Plan (CQMP) will need to complete and enter regulatory and participant chart reviews into the CQM Database within 30 days of the end of the review period according to the respective study complexity level.

For more information, access the DOSI CQMP website.

Data Safety Monitoring Board reports

If your project has a Data Safety Monitoring Board, a report from the Board will likely need to be included with scheduled reports to the sponsor. Your notice of award should include details surrounding expectations for Data Safety Monitoring Board reports.

Animal tracking reports

For IACUC approved protocols, investigators are required to track and document the approximate number of animals acquired or generated (through breeding or other means). Reports should be provided on animal numbers used at the request of IACUC, other members of the Duke Animal Program, or other appropriate internal or external oversight bodies.

Access the animal tracking SOP for more information about process and policies.

Final reports and disclosures

Final sponsor reports

Sponsors generally require a final report to be submitted within a set time frame of the award ending. Research teams should coordinate to complete the final reports to the sponsor as they often include both scientific and financial updates. Requirements for the final report should be stated in the terms and conditions of the award or contract.

If your final report requires an intellectual property report, please email your request to tonya.peace@duke.edu to get your Final Inventions Statements Form (sometimes referred to as DD882) signed off by the Duke Office for Translation and Commercialization.

Invention disclosures

If any inventions or new technologies arise from your research, an Invention Disclosure Form should be submitted to the Duke Office for Translation and Commercialization to begin the process of protecting your idea.

IRB and IACUC final reports
  • For DUHS IRB protocols, a final report must be submitted in iRIS (located under the Submissions tab, Submission Forms header) to formally closeout a protocol. Access the Close out the project page for closeout procedures that need occur prior to submitting a final report. 
  • IACUC and Campus IRB protocols do not require a formal final report, but should follow all applicable closeout procedures. Access the Close out the project page for more information about closeout procedures.