The Human Study Lifecycle
Starting Your Human Study
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You can contact the Marketing, Communications & Media division, for consultation (no fees) to learn about the multiple tools and methods available. Contact: Linda Lopez-George, Director, Research Marketing firstname.lastname@example.org or 210-562-4035.
- Customize the study description on Find-A-Study to target your population of interest.
- Update recruitment status (e.g., open or closed to enrollment)
- View the list of volunteers who have expressed interest in your study.
Financial Management Startup
The contract (or clinical trial agreement) between the industry sponsor 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.
Billing Sponsors: Startup
Invoice for Study Startup fees
Coordinate with your department or organized researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. unit ( ORUORUOrganized Research Unit provides support for interdisciplinary research that complements the academic goals of departments of instruction and research. ) administration to ensure the sponsor 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 sponsorSponsorare the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study. for the initial and continuing “institutional review” fees.
Clinical Trial Management System (CTMS)
All clinical trials are registered in our CTMS 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. by the Clinical Trials Office. After the ResearchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 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 eResearch is the electronic interface with UT Health PhysiciansUT Health Physiciansis the clinical practice of the Long School of Medicine of UT Health San Antonio electronic medical recordElectronic Medical Record(EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility. (EPIC). As part of the subject 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. process, eResearch connects to the individual’s record in EPIC and “flags” the individual as a research participant. The “research flag” plays an important role in alerting other providers that the patient is enrolledEnrolledscreened participants are enrolled if eligibility is verified (meet all inclusion criteria and none of the exclusion) and they consent to continue in the study. 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
Research team members who are responsible for managing study records in eResearch are required to complete the one-time training module through the UT Health Learns System before they can obtain access to eResearch. At the end of the online eResearch training course (Module 4), complete the survey to request access.
Work instructions on the various eResearch functions are provided on the Velos Work Instructions page.
Click on this link to login to the Velos eResearch System
Get help with Velos eResearch CTMS-Support@uthscsa.edu
Clinical Trial Registration (CT.gov)
Clinical Trials.Gov registration is required if any of the following apply:
Reporting Requirements ICMJE Policy
FDAAA Final Rule
(Results Reporting Required)
Final NIH Policy
(Results Reporting Required)
Phase All Phases Phase 1 (feasibility) excluded All Phases InterventionInterventionall physical procedures by which information or biospecimens are gathered or manipulation of the subject or the subject's environment performed for research purposes. Type All interventions
Interventions involving drugs, biologics & devices regulated by FDAFDAabbreviation for US Food and Drug Administration.
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 HHSHHSabbreviation for Health and Human Services (HHS) or the Department of Health and Human Services (DHHS) funding
Loss 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 identifiedIdentifiedindividual is identified as a prospective subject during recruitment: 1) by obtaining the results of procedures performed as part of the practice of medicine, 2) by responding to recruitment activities, or 3) referred by a provider. during the National Library of Medicine (NLM) quality control review process.
Contact OCRmail@uthscsa.edu or 567-8555 to request assistance with CT.gov registration or questions.
Conducting Research at Affiliate Hospitals
We've integrated operations with our affiliate's research adminstrative offices and committees as follows:
VA - South Texas Veterans Health Care System (STVHCS) requires approval by the STVHCS Research and Development Committee.
University Health requires approval by the University Health Research Committee.
If you plan to conduct research at any other institutions, contact the Office of Clinical Research. Institutional approval is handled on a case-by-case basis.
Contact the OCR for more information at OCR@uthscsa.edu
UT Health San Antonio Policy
Collaboration with foreign entities must be approved prior to starting researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. .
Disclose foreign collaborations using iDisclose
In some circumstances, the Health Science Center may be required to obtain prior approval from the appropriate agency before allowing foreign nationals to participate in research, 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 conflict of interestConflict of Interestrefers to situations where the individual has the opportunity to influence the Health Science Center's business, administrative, academic, research, clinical, or other decisions in ways that could lead to personal financial gain or advantage or could appear to cause bias in the design, conduct, or reporting of research or educational activities. 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