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Starting Your Human Study

• Participant Recruitment

  Marketing Division

  You can contact the 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

    a pre-enrollment activity used to find potential subjects.

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    status (e.g., open or closed to

    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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    )
  • View the list of volunteers who have expressed interest in your study.

• Financial Management Startup

  The contract (or

  one type of Clinical Research that follows a pre-defined plan or protocol. Subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

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  agreement) between the industry 

  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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  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

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

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  unit (

  Organized Research Unit provides support for interdisciplinary research that complements the academic goals of departments of instruction and research.

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  ) administration to ensure the 

  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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  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

  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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  for the initial and continuing “institutional review” fees.

• Clinical Trial Management System (CTMS)

  All clinical trials are registered in our CTMS

  Velos eResearch is �����Թ�'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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  by the Clinical Trials Office.  After the

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

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  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

  Velos eResearch is �����Թ�'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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  is the electronic interface with

  is the clinical practice of the Long School of Medicine of �����Թ�

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  (EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility.

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  (EPIC).  As part of the subject

  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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  process, eResearch connects to the individual’s record in EPIC and “flags” the individual as a

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

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  participant.  The “research flag” plays an important role in alerting other providers that the patient is

  screened participants are enrolled if eligibility is verified (meet all inclusion criteria and none of the exclusion) and they consent to continue in the study.

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  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

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

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  team members who are responsible for managing study records in

  Velos eResearch is �����Թ�'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.

  read more

  are required to complete the one-time training module through the  before they can obtain access to

  Velos eResearch is �����Թ�'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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  . At the end of the online eResearch training course (Module 4), complete the survey to request access.

  Work instructions on the various

  Velos eResearch is �����Թ�'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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  functions are provided on the Velos Work Instructions page.

  Click on this link to login to the 

  Get help with Velos

  Velos eResearch is �����Թ�'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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  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  (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 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 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 FDA Amendments Act (FDAAA) of an "Applicable Clinical Trial"

• Conducting Research at Affiliate Hospitals

  We've integrated operations with our affiliate's

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

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  administrative offices and committees as follows:

  VA - South Texas Veterans Health Care System (STVHCS) requires approval by the STVHCS

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

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  and Development Committee.

  Learn more about the VA submission process

  University Health requires approval by the University Health

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

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  Committee.

   

  If you plan to conduct

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

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  at any other institutions, contact the Office of

  the broad category of biomedical or health outcome research designed to assess pre-defined groups of individuals.

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  .  Institutional approval is handled on a case-by-case basis.  

  Contact the OCR for more information at OCR@uthscsa.edu

• Foreign Collaborations

  �����Թ� Policy

  Collaboration with foreign entities must be approved prior to starting

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

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  .

  Disclose foreign collaborations using ERMS-COI.

  In some circumstances, the 

  abbreviation for The University of Texas Health Science Center at San Antonio or �����Թ�

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   may be required to obtain prior approval from the appropriate agency before allowing foreign nationals to participate in 

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

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  , 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

  refers 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.

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  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