The closeout process involves closing out programmatic, administrative, and financial activities and typically includes all members of the research team - the investigator, scientific staff, and the grant manager. Ideally, closeout plans should be thought about from the beginning of the project, and should pay careful attention to the sponsor's and Duke's requirements.
Additional closeout considerations may be required if the investigator is leaving Duke or transferring to another institution:
Data and other research outputs
When a research project is complete, all primary data, code, software, and other research outputs should be curated for sharing in accordance with the funder, data provider, program, and institutional requirements, or for long-term archival. For studies involving human subjects or human data, this includes de-identifying all protected health information in accordance with HIPAA guidelines.
- For more information about curating data to prepare for data sharing, access the Engage in open science and open scholarship page.
- For more information about archival options for paper files and electronic data, access the Archive data and documents page.
Secondary data should be deleted in accordance with the terms of any contracts or data use agreements that Duke signed on the researcher's behalf. Also, all compute and temporary storage resources may need to be de-provisioned or deleted once the curated outputs of the project have been archived.
- For assistance, contact the research support office that signed the contract or agreement to obtaining the data, or contact the Research Facilitation & Data Services team for guidance or to be connected to the appropriate support office.
Regulatory closeout (IACUC, IBC, IRB, FDA)
IACUC protocols do not require active animal use and will expire after approximately 3-years of approval. To close a currently approved protocol submit a protocol amendment indicating the request to close. For information on closing an approved IACUC protocol contact OAWA at IACUC@Duke.edu or 919-668-6720.
Contact the IBC at firstname.lastname@example.org to initiate a transfer of the protocol to another PI, or to notify them that the protocol will be closed.
If an IBC protocol has a corresponding IACUC or IRB protocol, the respective IACUC or IRB closeout procedures should be followed.
Studies with a Campus IRB protocol that involve the collection of primary data are considered complete when participant enrollment and data collection are complete, and the data are permanently de-identified (identifying information and the key have been destroyed). Once the data are permanently de-identified, the researcher may continue to analyze the data, even after the protocol is closed, as this will no longer be considered research with human subjects. Contact the Campus IRB for any questions or to request to close a protocol.
If the researcher will be leaving Duke before the data have been de-identified or if access to the de-identified data is still needed, the protocol must remain open and be transferred to another researcher, or if transferring to another institution, a protocol must be created with the new institution’s IRB. If transferring, data that are currently stored in a platform or environment that requires a Duke NetID to access (such as Qualtrics or REDCap) will likely need to be moved to another appropriate storage solution at the new institution. The specific IT support for the Duke platform or environment being used for analysis and storage can provide assistance.
DUHS IRB protocols may be closed in iRIS after all of the following are complete:
- All DOCR study closeout procedures have been completed.
- All files and documents that relate to the protection of human research participants are appropriately stored and retained for at least six years following completion of the study, in accordance with the DUHS IRB Retention of Records Policy.
- Primary data are appropriately curated and archived
- If key personnel are leaving Duke or transferring to another institution and will need to retain access to the data, a data transfer agreement must be in place in accordance with DUHS IRB Policy.
FDA regulatory closeout
Projects that include an FDA regulatory application for an investigational product (drug, biologic, or device) will need to be appropriately closed out. Contact the Office of Regulatory Affairs and Quality at ORAQ@duke.edu for assistance with the FDA regulatory closeout process.
Animals, equipment, and controlled substances
Relocation, transfer, or disposition of animals
Contact DLAR at 919-684-2797 or LabAnimal DLAR Transfers (email@example.com) for more information on animal relocation, transfer, or disposition.
To change a non-centralized animal housing or use location on an IACUC protocol, submit a protocol amendment indicating the request for the new location(s).
Research equipment and supplies
All equipment purchased with grant, contract, or internal or discretionary funds are considered Duke property. Equipment that will be used for future research may remain in the laboratory or research space. Any equipment or supplies that are no longer needed at the conclusion of a research project should either be put in temporary storage if the investigator has needs for the equipment at a later date, or should be processed through the Duke Surplus Property Program.
Leased or rented equipment should be handled in accordance with any terms established upon setting up the agreement. Contact PlantAccounting@duke.edu for further assistance.
Studies that involve controlled substances should follow the proper disposal procedures in accordance with the Duke guidelines for the use and management of controlled substances in research.
For additional guidance on controlled substance use and management, including close-out, contact OAWA at IACUC@Duke.edu or 919-668-6720.
Additional requirements pertaining to clinical research protocols
The following federal and institutional processes should be completed when closing out clinical research protocols. Additional tools and checklists for closing out a clinical research protocol are available in the "Related Resources" section of this page.
The ClinicalTrials.gov recruitment status should be updated within 30 days of completing data collection. If results are required, they should be entered and accepted by ClinicalTrials.gov prior to closing the study with the IRB. For questions or assistance, contact DOCRfirstname.lastname@example.org.
OnCore and Epic statuses
All participants should be in an inactive status (e.g., off study, ineligible) prior to submitting a final report to the IRB. The OnCore study status should be updated to “IRB Study Closure.”
On a monthly basis, DOCR will review all protocols that have been closed in the IRB and complete the RSH record in Maestro Care if all participants are in an inactive status in both systems and the RSH005 is cleared of all charges.
The investigator and grant manager should work together to complete all NIH closeout requirements. The following documentation is required to closeout an NIH award within 90 calendar days after the project period end date:
- Final Federal Financial Report (to be submitted by the Duke Office of Sponsored Programs)
- Final Progress Report
- Final Invention Statement and Certification
Closeout documents must be submitted via eRA Commons. More information about the financial closeout process can be found on the Award closeout page.
Information about financial closeout of sponsored research projects is available on the Award closeout page.