Study Closeout

Closing out a clinical research study involves a comprehensive series of steps to ensure all aspects of the study are appropriately concluded and documented. Closing out a study means a study is completed and no further identifiable data analysis is required and there are no more interventions or interactions with subjects.

Initially, it is vital to confirm that all required source documentation and case report forms are complete, whether paper-based or electronic. Data management tasks include ensuring data entry completeness, resolving any queries, and locking the database. Adverse events and other reportable incidents must be captured, followed, and properly reported to the IRB. The study should be closed with Kuali IRB.

How do I close out a study?

Complete a “request close” submission and upload required documents. Review the ”Steps to
Submitting a Closure” document, which provides step-by-step directions on how to complete this process.
If the submission for closing out a human subjects research study is not received by the protocol
expiration date in the approval letter, meaning the research approval expires, you will be required to
develop and implement a suitable CAPA and may be restricted from submitting new human subjects
research until the completed closure application has been received and approved.

How long do I need to keep records?

Research records belong to the Regents of the University of California. These records are confidential
and must be stored securely in your university office, in your department, or in another approved location
at the university or approved archiving facility. Records to be kept include, but are not limited to,
submissions made in Kuali IRB, consent forms, HIPAA authorization forms, case report forms (CRFs),
tapes or transcripts, all other data collection instruments and source documents, and training records. If
multiple retention requirements apply to the research, the longer requirement must be followed. All
records must be accessible for inspection and copying by authorized representatives of the IRB,
regulatory agencies, and study sponsor. Identifiable records must not be accessed or used for research
purposes after study closure.

UCOP requires that research data be kept in accordance with the University of California
Research Data Policy.
DHHS regulations require records from federally funded research to be kept for 3 years after
completion of all research activities.
FDA regulated research records must be kept for 2 years after a marketing application is
approved.
For FDA-regulated research where no application is filed or the application is not
approved, the retention period is 2 years after the investigation is discontinued and FDA
is notified.
Contractual obligations may require records to be maintained according to the agreement
terms with the trial sponsor.
HIPAA requires records involving the generation, disclosure, and/or use of protected health
information (PHI) to be retained for at least 6 years after the last subject has completed study
activity.

Contact the Office of Compliance and Privacy for more information about HIPAA-related matters and document retention requirements.

Award Closeout

The majority of agencies (federal and non-federal) require the University to submit a final invoice or financial report when a project ends. These agencies may also require final technical reports, final invention reports as well as final equipment reports at the end of the project.

While federal sponsors have had policies in place to withhold funding from PIs (and/or institutions) with delinquent awards missing required closeout documentation, they have recently started increasing the level of communication around these policies, thereby making enforcement of these policies more likely. This significantly increases the risks associated with not properly closing out awards. These notices and warnings are coming from major federal sponsors such as NSF and NIH, further increasing the potential risk to UC San Diego's research portfolio.

Closeout Responsibility Summary

Office / Personnel Responsible	Closeout Responsibilities
Department: Principal Investigator (PI) Research Administrator (RA)	Prepares and submits required reports timely to the appropriate central office Track RPPR, Progress reports, technical reports, etc. Assist PI’s with sponsor reports Financial Closeout with SPF Submit the Financial Expense Report (FER) and all backup documents within 30 days of the project end date Cost sharing, effort reporting
SPF: SPF Accountant	Prepare/Submit final financial reports and invoice
SPO: SPO Coordinator	SPO Coordinator follows up with Departments when reports are past their due date. If no patents – PI/RA lets SPO know, SPO Coordinator will sign and submit to the agency If patents – PI/RA needs to complete a section of the form and coordinate with OIC, the SPO Coordinator will sign and submit it to the agency
SPO: SPO Officer	Coordinates with the Departments the submission of final technical project reports and other reports that may be required (e.g. Patent Certs, Property Close)
Equipment Asset Management: Financial Analyst	Final property reports are submitted to the sponsor by the Equipment Asset Management Office consulting with the PI to determine if there are any disclosures.

Final Reports

The Principal Investigator(s) (PI) and department are responsible for the submission of all technical reports required under the terms of an award in the form required by the sponsor. Sponsors may also require an annual progress report, final technical report, final property as well as a final invention statement.

PIs and department representatives should consult the Research Administration Activity Dashboard - Awards Ending or Ended Reports and/or their award terms to determine what reports are required and when the sponsor expects to receive these reports. See here to access a Quick Guide on how to use the Research Administration Activity Dashboard

The PI and department are also responsible for ensuring that each subrecipient has submitted all required reports and deliverables to UC San Diego prior to approval of final payment to the subrecipient.

It is important to know where and how the sponsor expects such reports to be submitted. For example, the National Science Foundation (NSF) now expects the PI to use Research.gov (instead of FastLane) to meet all NSF project reporting requirements, including submission of final, annual, and interim project reports and the Project Outcomes Report. Please see NSF’s closeout guidance. However, the National Institutes of Health (NIH) requires grantees to submit Research Performance Progress Reports (RPPR) and final technical reports through the eRA Commons.

In short, each sponsor has guidelines about how, when and where progress and final reports should be submitted. It is critical to read the “Reporting” requirements of an award carefully prior to submission of these reports.

When an invention is developed under a federally sponsored project, it is disclosed by the PI to the Office of Innovation and Commercialization (OIC). OIC is responsible for notifying the federal sponsor about this invention via iEdison. iEdison is an electronic system for grantees and contractors to report inventions arising out of federally funded research to the government agency that issued the funding, as required by the Bayh-Dole Act.

Failure to comply with the reporting requirements of the sponsor can have significant repercussions. For example, the PI’s future funding from the sponsor can be jeopardized. A sponsor also may hold up all new awards to UC San Diego just because of one PI’s delinquent technical report.

Important note: When submitting a progress or final technical report to a sponsor, PIs and/or Department Research Administrators are required to keep a copy of the report and documentation that the report was submitted as well as send a copy of these reports to their SPO (the SPO will upload these reports along with the submission date to the Award record). Reports can be sent to the SPO using this Service Now form or by emailing the officer directly. This step is important in case the sponsor fails to record the receipt of the report accurately.

The SPO will provide assistance with any questions, sign any reports if required by the sponsor, and submit any reports if required by the sponsor.

For additional information or questions email awardcloseout@ucsd.edu.

Office of Sponsored Projects and Department Financial Administrative Responsibilities

The Office of Sponsored Projects Finance (SPF) is responsible for preparing financial reports, submitting them, and certifying on behalf of the University that project expenditures comply with the sponsor's financial terms and conditions. If you manage sponsored projects for your department, you assist in this process visit the Preparing for a Final or Annual Reporting page.

For additional information or questions see the SPF Contacts page.

Learn more about award management and closeout here.

Resources

NIH/NIDCR Study Closeout Checklist

Helps the investigator plan orderly closure of study documents, data, and publication.

NIH/NIDCR Site Close-out Visit Readiness Checklist (example)

An example checklist to clarify the items required prior to scheduling a site close-out visit (specific to NIDCR-supported studies)

DSBM Final Study Report Template

MS Word template to be used as a starting point for preparing the final DSMB report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance.