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Close the Study

Close the Study

Once a study is complete, there are a number of steps that must be taken to properly close out the project. The remainder of this page presents the steps, instructions, and contact information related to study closeout.

Finalize Study Data

Finalize Study Data

Once data collection is complete, the research team must verify that all Case Report Forms have been completed and links to identifiers for data to be retained have been destroyed as required by the IRB-approved protocol. Of note, even when other records, source documents, specimens, or data are de-linked per IRB-approved protocol, the signed consent forms and HIPAA forms must be retained, without alteration. Discuss any questions with the IRB or your funding agency/sponsor.

UW HUMAN SUBJECTS DIVISION
(206) 543-0098 | hsdinfo@uw.edu
Study Closure Procedure

Close Out Research Support Services / Facilities

Close Out Research Support Services / Facilities

Let the department(s) that supported the study know the study has ended in case they have processes to close out their role. For example, UW Investigational Drug Services (IDS) needs to complete a final drug inventory and ensure that any remaining drug is returned to sponsor or disposed of appropriately.

ITHS CLINICAL RESEARCH CENTER
Hyacinth Lee, RN, Health Services Manager
(206) 598-8933 | hlee43@uw.edu
Research Center Website

IDS PHARMACY
Harborview: (206) 744-5448 | hmcids@u.washington.edu
UW Medical Center (206) 598-6054 | uwmcids@u.washington.edu
IDS Pharmacy Website

UW LABORATORY MEDICINE
Administration
(206) 598-6131 | lmofficesupport@uw.edu
Lab Medicine Website

Research Testing Services
(206) 616‑8979 | rts@uw.edu
Research Testing Services Website

UW DEPARTMENT OF PATHOLOGY (NWBioSpecimen)
Sarah Bowell
(206) 221-6096 | nwbt@uw.edu
Pathology Request Website

UW DEPARTMENT OF RADIOLOGY RESEARCH PROGRAM
Laura Grant
(206) 543-1802 | grantl2@uw.edu
Radiology Research Website

ITHS RESEARCH COORDINATION CENTER FOR RESEARCH STAFFING
Amy Good, Implementation Lead
(206) 412-7320 | amygood@uw.edu
RCC Website

Records Retention

Records Retention

Generally, UW-held research records must be retained for six years. Records retention must also comply with all other applicable regulations governing the study, including UW Records Retention Schedules. There may be additional requirements associated with the funding agency/sponsor or other agencies, like the FDA, involved in the research.

UW RECORDS MANAGEMENT
(206) 543-0573 | urc@uw.edu
UW Records Website

If you are in the UW School of Medicine, more specific information about storing UW Medicine patient research records can be found at:

UW MEDICINE RECORDS MANAGEMENT SERVICES
(206) 598-2242 | HRC@uw.edu
UW Medicine Records Management Website

Final Reports

Final Reports

Submit final reports to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and/or your funding agency/sponsor.

UW HUMAN SUBJECTS DIVISION
(206) 543-0098 | hsdinfo@uw.edu
IRB / HSD Study Closeout Procedure

FDA regulations require investigator-sponsors who hold an Investigational New Drug (IND) to submit a final report to FDA: FDA IND Regulations

FDA also provides a suggested format for investigator-initiated Investigational Device Exemption (IDE) Final Reports: FDA IDE Regulations

Check with your funding source or industry sponsor for more information on their report requirements.

Billing Closeout Request

Billing Closeout Request

Within 45 days following the delivery of the final study service, use this survey to submit a billing closeout request to UW Clinical Research Budget & Billing (CRBB) to deactivate your Epic “RRR” study account: Billing Closeout Request

UW CLINICAL RESEARCH BUDGET AND BILLING
(206) 543-7774 | crbb@uw.edu
Study Closure Procedure

Final Accounting of Research Funds

Final Accounting of Research Funds

Contact your department fiscal specialist and UW Clinical Research Budget & Billing (CRBB) to ensure that all allocable costs have been charged to the study. Both your departmental fiscal specialist and the CRBB representative will work with you to ensure that all funds due to the UW have been received, as well as confirming that all funds received have been earned.

You and your department fiscal specialist can contact the UW Office of Sponsored Programs (OSP) and UW Grant & Contract Accounting (GCA) to determine the appropriateness of remaining funds to stay with UW, as well as resolution of overdrafts, balance transfers to income accounts, and final closure of the research budget.

UW CLINICAL RESEARCH BUDGET AND BILLING
(206) 543-7774 | crbb@uw.edu

UW OFFICE OF SPONSORED PROGRAMS
(206) 543-4043 | osp@uw.edu

UW GRANT & CONTRACT ACCOUNTING
(206) 616-9995 | gcahelp@uw.edu

Posting Data to Clinicaltrials.gov

Posting Data to Clinicaltrials.gov

Upload study data and post your study results on www.clinicaltrials.gov.

NIH-Funded Research Publication Resources

NIH-funded Research Publication Resources

For NIH-funded research, or research supported in-part by NIH grant resources, the National Institutes of Health Public Access Website provides instructions on NIH requirements for preparing manuscripts, what to do once your publication is accepted, and citations/reporting about upcoming publications.

Cite ItThe Institute is supported by grants UL1TR000423, KL2TR000421, and TL1TR000422 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA). Please help us continue to support your research by citing our grant number(s) in publications we supported.