The Human Study Lifecycle
Closing Out Your Human Study
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UTHSA IRB of Record
External IRB of Record
IRB Inactivation/closure for external IRBExternal IRBAn IRB operated by an organization other than UTHealthSA studies should be submitted through the overall PI (as applicable) to the IRB of RecordIRB of Recorddenotes the IRB responsible for approval of a specific research study at a given institution. . A copy should be submitted to OCRmail@uthscsa.edu with an Institutional Inactivation Form. The PI should be copied on the submission email.
See Institutional Review Policy and Procedure for further guidance.
Clinical Trial Management System
Within Velos eResearcheResearchVelos eResearch is UT Health San Antonio's designated Clinical Trial Management System (CTMS). Velos eResearch is a web-based application designed to centralize the management tasks needed to conduct a clinical trial including study statuses, subject enrollment and activity, study calendars, budgets and billing. the following actions should be taken to close out your study:
- Study enrollmentEnrollmentthe process of seeking eligible participants and obtaining their consent to participate in the research. Enrollment generally starts with recruitment, leading to screening for eligibility, and consent to enroll in the study. status should be updated to include the enrollment closure date.
- All participant records should be up to date and the patient statuses should be moved to off-study.
Good records are essential for verifying the quality of study data produced, confirming protection of participant rights/welfare, and demonstrating investigator compliance with regulations, laws and institutional policies. UTHSA investigators must retain researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. records in accordance with federal, institutional, and sponsorSponsorare the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study. requirements. The regulatory mandate for records retention depends upon which regulations are applicable to the research. For some documents UTHSA requires much longer retention than some federal requirements. Investigators must comply with all applicable requirements.
Learn more about UT Health Records Management
Learn more about Study Documentation Standards
Research Data Ownership
Researchers may request permission to take original researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. data when leaving the university. To do so please contact Melanie Zuñiga Rapp at firstname.lastname@example.org or 210-562-6838.
HOP 7.10.1 provides research data definitions, obligations to retain, archive and make data available for collaboration. The policy summarizes other regulations, policies, agreements and circumstances that impact research data retention and access.
Learn more about other research data retention and access rules.
Financial Management Close Out
Following site closure or receipt of final payment from the funding sponsor, a final reconciliation of the study financial file and PID should be completed within 30 calendar days. This reconciliation should include verification of the following items;
- Applicability of payments received or not received based on the study agreement.
- Expenses or payables to service providers or other institutions should be verified an notifications the study has closed should be submitted
NOTE: Discrepancies should be submitted to the appropriate party for resolution prior to financial closure being completed.
Following completion of the final reconciliation and resolution of any issues;
- For studies with a study-specific PID a notification should be sent to OSP at Contracts@uthscsa.edu, OSP will close the study PID and transfer any residual balance to a non-grant 48001 fund group PID according to institutional policy.
- Financial records for the study should be maintained in accordance with institutional policy.