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The Clinical Trials Office (CTO) staff works closely with research teams at UT Health San Antonio to build billing calendars within our Clinical Trial Management System based off the approved Clinical Trial Agreement for your study. These administrative and patient calendars assist the CTO team with sending invoices to the Sponsors on your behalf. Velos eResearch is our Clinical Trial Management…, Administrative Start-up and Annual Invoicing:, Invoicing for Administrative fees will be completed by CTO staff. These fees are not directly associated to a patient: For example: Study Start-up, Pharmacy Start-up, Laboratory Start-up, Administrative Annual Fees, Monitoring Visits, Budget Modification Fees, Chart Reviews and Close-out., Patient-Related Procedures: Tracking of patient receivable and , invoiceable items for patient-related procedures as agreed upon in your study’s Clinical Trial Agreement will be completed by CTO staff. The study team is responsible for tracking patient enrollment in Velos and the patient’s progress completed on the study. Once the study team’s enters information, receivable and Invoiceable milestones will be triggered; this will generate an invoice on CTO’s…, IRB Approval and IRB Continuing Reviews: , Invoicing for Initial IRB approval fees and ongoing re-approval fees will be completed by CTO staff. These fees are not directly associated to a patient: For example: IRB Initial Internal IRB fees, IRB initial External IRB fees, and Continuing Review Annual Progress Report IRB fees., What does this mean to you?, Administrative and patient calendars are built from your study’s budget and/or Coverage Analysis. This makes input from the study team, VERY IMPORTANT, . Please let us know if your admin or patient calendar do not line up with your Coverage Analysis. When your patient calendar is activated and ready to enroll patients, you will receive an e-mail from VPRCTO@uthscsa.edu labeled “Velos eResearch Activation Notice” with detailed instructions on study and patient management in Velos. The study team is required to associate their patients with the…
The Clinical Trials Office manages and oversees the Participant Payment program and ClinCard application for all clinical trials. Our team works closely with investigators and their teams, the IRB, and OSP to ensure that the Participant Payment Form matches the informed consent, follows the Institutional Handbook of Operating Policies, and is in alignment with the budget associated with industry-…
The VPR ’ s Clinical Research Implementation Office (CRIO) team is a vital resource for researchers across UT Health San Antonio. Comprising expertise in clinical translational science methods, protocol development, ClinicalTrials.gov and Federal Drug Administration (FDA) IND/IDE applications and clinical trial recruitment/retention strategies, the CRIO team supports investigators at every…, Are you gearing up for your first consultation with the CRIO team? , Knowing what to expect can help you make the most of your time and resources. Here is a guide to ensure your first meeting is as productive as possible. By following these guidelines, you will be well-prepared for your first CRIO consultation, setting the stage for a successful research journey. , Preparation is Key , Before your consultation, it is essential to have a clear understanding of your research question and objectives. While the CRIO team is here to help refine your ideas, coming prepared with a well-thought-out research question will allow for a more focused and effective session. If you have already drafted your specific aims or hypotheses, bring them along. This will help the CRIO experts…, Walk Through Your Research Plan , During the consultation, you will be asked to give an overview of your research. Be ready to discuss your study design, the populations you will engage, the data you have gathered (or plan to gather) and any preliminary analysis you have done. This is your chance to walk the CRIO team through your research journey, highlighting what you have accomplished so far and where you might need additional…, Understand the Scope of Your Project and Research Start-Up Process , One of the shared challenges for researchers is aligning their research plans with the resources available. The CRIO team may ask insightful questions about whether the project's scope is realistic, given your time, funding and data constraints. This step is crucial for setting you on a path to success and avoiding the pitfalls of overextending your study beyond feasible limits. We want to help…, In-Person and Virtual Options , CRIO consultations are available both in person and virtually, providing flexibility to fit your schedule. While virtual meetings offer convenience, an in-person consultation is often recommended for the first meeting, especially if you are new to the UT Health San Antonio research process. This allows for a more interactive session where you can establish a rapport with the CRIO team and discuss…, Involving Your Mentor , If you are a trainee, it is essential to include your mentor in your first CRIO consultation. Having your mentor present can provide additional context and ensure that all who are involved with your research are aligned with the research goals and methodology. This collaboration can help the CRIO team offer more effective guidance and support. , Consultation Intake Form , Before scheduling your consultation, be sure to complete the Concierge request form . This form helps the CRIO team prepare for your meeting by gathering essential information about your project in advance. It only takes a few minutes to fill out but it is a crucial step in ensuring a productive consultation. , Networking Opportunity , Remember, a CRIO consultation is not just a meeting; it is an opportunity to connect with experienced researchers and staff who can offer valuable insights and support. Treat this session as a chance to expand your professional network and lay the groundwork for future collaborations. Or email us at, CRIO@uthscsa.edu, .
List of All Required Training, Click on the headings below that apply to your research to find more information about required training.
UT Health San Antonio recognizes the value of scientific collaboration and welcomes Visiting Scholars from across the United States and around the world. Visiting Scholars foster collaboration, diversity and professional relationships while fulfilling UT Health San Antonio’s mission of excellence in education, research, health care and community engagement. Visiting scholars are individuals who…, HOP 7.10.4, ., Types of Visiting Scholars, Observer:, Individuals who hold an undergraduate or higher degree with interest in a biomedical or health care related field and seeking to observe (i.e., only to watch, listen, and learn; no hands-on activities allowed) UT Health San Antonio research faculty, including UT Physicians conducting research., Professional Trainee:, Individuals who hold an undergraduate or higher degree with an interest in a biomedical or health care related field and are seeking additional non-clinical hands-on training in research for educational purposes or professional development., Visiting Scientist:, Individuals who are established and accomplished scholars and can contribute to and enrich the university's research, intellectual, and academic endeavors. Visiting Scientists should currently hold an appointment comparable to UT Health San Antonio faculty., Application Review Process, To initiate the Visiting Scholar approval process, please submit a , Visiting Scholar Application, via RedCap. Once the application is received, the Office of Research Administration & Quality will reach out to the host to set up an intake meeting and coordinate with stakeholders throughout UT Health San Antonio. Such stakeholders may include the Office of Human Resources, host department administration, Office of Sponsored Programs, or the Office of International Services., The following supporting documents will be required upon application submission:, Visiting Scholar CV Summary of intent that includes the following information: Scope of Work and how the Visiting Scholar will contribute to your work Overview of the experience or expertise the visitor hopes to gain during their stay For international visitors: Copy of Passport Current Visa, if available, Onboarding, Prior to the Visiting Scholar’s appointment, the following onboarding requirements must be met: POI Appointment Badge UTHSCSA Domain Email Required Training New Employee Orientation Title IX HIPAA FERPA Information Security Office Annual Security Awareness Training Institutional Compliance Program Equal Employment Opportunity Laws Conflict of Interest CITI Training (depending on scope of work)…
Enterprise Research Management System (ERMS), Technical assistance; log in issues; elevated permissions and reporting for the below modules: Agreements COI & COC IRB, Submit an Issue or request assistance, ORCA (Online Research Compliance Assistant), Animal study submission and management support Human study details and documentation Central Office application support, ORCA Analyst, CTO Analyst, PIMs Online, Find A Study web application, Technical assistance; log in issues; updates to data presented to the public, Submit an Issue or Request Assistance, Clinical Trial Management Systems, Velos eResearch, Training Information, Information and Logon, Request Access or Submit an Issue, Complion, Training Information, Request Access, Assistance or Submit an Issue, Core Facilities Web Applications, iLab, Request Access or Submit an Issue, Freezerworks, Request Access or Submit an Issue, Data sharing resources, through PowerBI, Scholars, /Pure, Data integration and sharing, Specializes in developing APIs for Efficient Data Retrieval – extract data from diverse sources, including web services, databases, and third-party platforms, ensuring seamless integration with your existing systems. Seamless Integration - automatic data retrieval and synchronization, eliminating manual efforts and reducing the risk of errors. Customized Reporting - With the data fetched, we…
Authority, HOP 1.6.6 Institutional Review Board , Administration, VPR Policy Study Reviews for Human Research HOP 7.2.1 Human Research Protection Program Responsibilities HOP 7.2.2 Institutional Review Board (IRB) Responsibilities , Supporting Committees and/or Programs, Safety, HOP 1.5.2 Institutional Biosafety Committee HOP 1.5.12 Radiation Safety Committee HOP 1.5.13 Radioactive Drug Research Committee , Office of Sponsored Programs, HOP 7.1.1 Policies and Procedures HOP 7.1.7 Export Controls , Misconduct, HOP 7.6.1 Research Misconduct , Senior Legal Offices, HOP 10.1.2 Code of Ethics and Standards of Conduct , Conflict of Interest, HOP 1.6.11 Conflict of Interest Committee HOP 10.1.6 Conflicts of Interest in Research and Disclosure HOP 10.1.12 Institutional Conflict of Interest Policy , I nstitutional Compliance and Privacy Office (ICPO), HOP 2.5.1 Institutional Compliance Program , Clinical Trials Office, HOP 7.7.1 Clinical Research Billing Compliance HOP 7.7.2 Management of Research Participant Payments , Institutional Review Board Office, HOP 1.6.6 Institutional Review Board HOP 7.2.1 Human Research Protection Program Responsibilities HOP 7.2.2 Institutional Review Board (IRB) Responsibilities , Office of Technology Commercialization, HOP 12.1.1 Intellectual Property Policy
Velos eResearch is the Clinical Trial Management System (CTMS) for the institution, which is used to document the study and patient activity for the institution. All studies that meet the NIH definition of a clinical trial or the definition of a billing risk as defined by HOP 7.7.1 are required to be registered in Velos eResearch. Before access can be granted users are required to complete the…