Need Help?
OIRB: IRB@uthscsa.edu; 210-567-8250
Starting Your Human Study
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Participant Recruitment
Marketing Division
You can contact the Marketing, Communications & Media division, for consultation to learn about the multiple tools and methods available.
Find-A-Study
- Customize the study description on Find-A-Study to target your population of interest.
- Update status (e.g., open or closed to )
- View the list of volunteers who have expressed interest in your study.
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Financial Management Startup
The contract (or agreement) between the industry and the university described in the "Logisitics" stage sets forth the payment schedule, allowance for conditional payments, withholding percentage, invoice submission method, timelines for invoicing and payments and payment dispute procedures.
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Billing Sponsors: Startup
Invoice for Study Startup fees
Coordinate with your department or organized unit ( ) administration to ensure the is invoiced for the start-up fees according to the terms of the contract. The CTO/ORU will track payments and ensure funds are deposited in the applicable research PID.
Institutional Review fees
VPR CTO will invoice the for the initial and continuing “institutional review” fees.
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Clinical Trial Management System (CTMS)
All clinical trials are registered in our CTMS by the Clinical Trials Office. After the Coverage Analysis is approved, the CTO builds the necessary study calendars. The study team is then responsible for using eResearch to document study progress.
An important feature of is the electronic interface with (EPIC). As part of the subject process, eResearch connects to the individual’s record in EPIC and “flags” the individual as a participant. The “research flag” plays an important role in alerting other providers that the patient is in a study. It also ensures accurate billing because all patient charges are channeled to a special review queue where the charges are compared to the research coverage analysis
Learn more about Minimizing Clinical Billing Errors
team members who are responsible for managing study records in are required to complete the one-time training module through the UT Health Learns System before they can obtain access to . At the end of the online eResearch training course (Module 4), complete the survey to request access.
Work instructions on the various functions are provided on the Velos Work Instructions page.
Click on this link to login to the Velos eResearch System
Get help with Velos CTMS-Support@uthscsa.edu
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Clinical Trial Registration (CT.gov)
Clinical Trials.Gov registration is required if any of the following apply:
Reporting Requirements ICMJE Policy
(effective 2005)FDAAA Final Rule
(Results Reporting Required)Final NIH Policy
(Results Reporting Required)Phase All Phases Phase 1 (feasibility) excluded All Phases Intervention Type All interventions Interventions involving drugs, biologics & devices regulated by FDA All inverventions that affect one or more health-related biomedical or behavioral outcomes Funding Source All sources All sources NIH Enforcement Penalties Refusal to publish Civil proceedings and civil penalties (up to $10,000/day);
Loss of HHS fundingLoss of NIH funding for investigator and instituiton Responsible parties will be required to correct or address within 15 days for registration information and within 25 days for results information, any apparent errors, deficiencies and/or inconsistencies that are identified during the National Library of Medicine (NLM) quality control review process. Contact IRBreliance@uthscsa.edu or 210-567-8555 to request assistance with CT.gov registration or questions.
Learn more about clinicaltrials.gov
Learn more about FDA Amendments Act (FDAAA) of an "Applicable Clinical Trial"
Learn more if your study is funded by the NIH as a "Clinical Trial"
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Conducting Research at Affiliate Hospitals
We've integrated operations with our affiliate's administrative offices and committees as follows:
VA - South Texas Veterans Health Care System (STVHCS) requires approval by the STVHCS and Development Committee.
Learn more about the VA submission process
University Health requires approval by the University Health Committee.
Learn more about the UHS submission process
If you plan to conduct at any other institutions, contact the Office of . Institutional approval is handled on a case-by-case basis.
Contact the OCR for more information at OCR@uthscsa.edu
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Foreign Collaborations
UT Health San Antonio Policy
Collaboration with foreign entities must be approved prior to starting .
Disclose foreign collaborations using ERMS-COI.
In some circumstances, the may be required to obtain prior approval from the appropriate agency before allowing foreign nationals to participate in , collaborate with a foreign company, or share research results with foreign nationals.
Learn more about Export Controls
National Institutes of Health Policy
The NIH requires recipients of their funding to report foreign activities through documentation of other support, foreign components, and financial to prevent scientific, budgetary, or commitment overlap. A foreign component is defined as: The existence of any “significant scientific element or segment of a project” outside of the United States.
Learn more about NIH Foreign Components