91PORN

Closing Out Your Human Study

• Clinical Trial Management System

  Within Velos

  Velos eResearch is 91PORN'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.

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  the following actions should be taken to close out your study: 

  • Study

    the 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.

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    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.
• Records Retention

  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

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  records in accordance with federal, institutional, and

  are the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study.

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  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. 

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  Learn more about Study Documentation Standards

• Research Data Ownership

  Researchers may request permission to take original

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  data when leaving the university​.  To do so please contact Melanie Zuñiga Rapp at zunigam5@uthscsa.edu or 210-562-6838.

  ​HOP 7.10.1 provides

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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   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.  

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• 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.