Information for Clinical Research

Clinical Trials Studio - Clinical Research

• Clinical and General Research Training

  CITI Training: As part of the IRB protocol approval process, all investigators engaged in research with human subjects are required to complete and maintain valid human subjects’ protection training through the CITI Program. For researchers and research staff conducting clinical trials, Good Clinical Practice (GCP training is required). For details regarding required CITI training please see the following link: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/irb/investigator-study-team/training

  Conflict of Interest Training & Disclosures: All UTMB faculty, professional staff, students, and employees engaged in research must complete COI training and submit an annual disclosure statement: https://www.utmb.edu/compliance/conflict-of-interest/overview

  IRB Submission Training and Guidance: The submission of research to the IRB involves two electronic systems: OnCore* and InfoEd. Resources related to navigating these two electronic systems can be found at the following links:

  • Navigating the IRB Class: https://research.utmb.edu/research-at-utmb/training-development/education-programs
  • Research Education Training Guides & Videos: https://www.utmb.edu/research/research-at-utmb/presentations-resources
  • IRB Training Guides & Tip Sheets: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/irb/investigator-study-team/submission-help

  *Note: OnCore is currently under development and is set to “go live” in mid-November 2022.

• Study Development

  Clinical Trials Studio: The Clinical Trials Studio is an initiative supported by a multidisciplinary team of accomplished clinical trialists aiming to assist UTMB investigators with beginning and refining their clinical trials. We assist researchers at any career level, and we provide feedback on trials at any stage of development: https://www.utmb.edu/its/enhancing-research/clinical-trials-studio/about-us

  ITS Biostatistics & Bioinformatics Walk-in Studio: A walk-in (no appointment necessary) studio to assist in research study design, generating or retrieving data, guidance with analysis of collected data, and any questions related to biostatistics, bioinformatics, or health informatics. The service provides highly qualified experts at NO COST.  The studio is held the 3^rd Monday of each month, 1:00pm-2:00pm, 6.110 Research Building 6.

  Research Ethics Consultation Service: The Research Ethics Consultation Service (RECS) aims to promote ethics regarding scientific research and development through the Institute for Translational Science (ITS) and the broader community of the University of Texas Medical Branch (UTMB). The RECS uses an integrative and collaborative approach to create an environment that enables ethical decision-making through openness, ongoing discussion, tailored training, and research regarding research ethics and integrity concerns: https://www.utmb.edu/its/enhancing-research/ethics-support

  IRB Protocol & Consent Templates: The Protocol template to be used is contingent upon the type of study being conducted (chart review, clinical trial, bio/data repository, etc.). Additionally, consent templates to be used are contingent upon the type of the study and the risk level (minimal risk vs. greater than minimal risk) of the study. Templates can be found here: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/irb/templates-forms

  Investigational Drug/Device submission: For clinical Investigations requiring an Investigational New Drug (IND) or an Investigational Device Exemption (IDE), the Office of Research Integrity and Regulatory Affairs supports the research investigator with guidance on regulatory standards and best practices, regulatory submissions, clinical trial management, risk-based monitoring for clinical studies, and compliance: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/research-integrity-regulatory-affairs

  Biosafety & Shipping of Biologics: The Department of Biosafety is responsible for programs concerning the safe use of recombinant and/or synthetic nucleic acids, infectious agents, and potentially infectious materials such as human sourced materials in the research, teaching, and clinical laboratories at the University of Texas Medical Branch (UTMB). This includes training, auditing, and consulting with researchers, laboratory personnel, faculty, and healthcare staff concerning compliance with the federal and state laws and regulations in these areas: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/biosafety/home

  UTMB Data Safety & Monitoring Board (DSMB) Service: The standing Data Safety Monitoring Board (DSMB) was established to meet the need of UTMB investigator-initiated studies requiring a DSMB. The board is tasked with providing services to ensure the ethical conduct of clinical trials and to ensure and protect the rights and safety of patients enrolled in a trial: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/research-integrity-regulatory-affairs/data-safety-monitoring-board/overview

• Statistics: Consultation, Software Licenses

  ITS Biostatistics & Bioinformatics Walk-in Studio: A walk-in (no appointment necessary) studio to assist in research study design, generating or retrieving data, guidance with analysis of collected data, and any questions related to biostatistics, bioinformatics, or health informatics. The service provides highly qualified experts at NO COST.  The studio is held the 3^rd Monday of each month, 1:00pm-2:00pm, 6.110 Research Building 6.

  Biostats4You: The Biostats4you website was developed to serve medical and public health researchers and professionals who wish to learn more about biostatistics. The site contains carefully selected and reviewed training materials especially suited for a non-statistician audience: https://biostats4you.umn.edu/

  HyperStat: Online statistics textbook: https://davidmlane.com/hyperstat/

  Online Stat Book: Online statistics education, an interactive multimedia course of study: https://onlinestatbook.com/2/

• Grant Writing Tools

  Grant Writing Template Paragraphs: Template language and paragraphs that can be incorporated into proposals are located, here: https://www.utmb.edu/research/research-at-utmb/template-paragraphs

  Grants for Lunch: Grants-for-Lunch program focuses on developing the grantsmanship skills of UTMB faculty and fellows, and to promote networking within our research community. Informal, interactive discussions cover grant writing and research program management with a primary focus on NIH funding. These sessions are led by experienced research faculty and research administrators, who make a short presentation on the given topic, then open the session for questions and answers. All faculty and fellows are encouraged to attend and participate https://research.utmb.edu/research-at-utmb/training-development/education-programs

  Postdoctoral Scientists Certificate Program (includes proposal preparation): The Graduate School of Biomedical Sciences (GSBS) offers certificate credit for postdoctoral scientists at UTMB. There is no cost to postdocs for this program—all tuition and fees are paid by the GSBS: https://www.utmb.edu/gsbs/postdoctoral-affairs/current-postdocs/certificate-program

• Feasibility Tools

  TriNetX: TriNetX at UTMB HEALTH provides researchers the ability to explore a limited, de-identified set of patient data. This tool is most useful for the identification of patient cohorts in preparation for research: https://www.utmb.edu/its/its-informatics-service-center/about-informatics

  Slicer/Dicer: Slicer/Dicer is a self-service reporting tool that allows users to investigate data in Epic without needing to request custom reporting workbench reports  Epic Training - Slicer Dicer

• Budget Development

  Federal Budgets: Guidelines and templates for internal budget development are provided by the Office of Sponsored Programs, here: https://www.utmb.edu/research/research-at-utmb/budget-guidelines

  Industry Budgets: Industry budgets, Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and Financial guidance are provided by the Office of Clinical Research, here: https://research.utmb.edu/research-at-utmb/office-of-clinical-research-(ocr)/cdas

  Budgets for studies using the CRC: For studies involving the use of the CRC, please contact Liz Ruiz (ebruiz@utmb.edu)

• IRB Application and Approvals

  OnCore & InfoEd Access: *Note: OnCore is currently under development and is set to “go live” in mid-November 2022. To conduct human subject research at UTMB you will use to two electronic systems - Velos e-Research and InfoEd. Velos e-Research is a tool to help investigators and coordinators manage the daily tasks of conducting clinical trials and is the first entry point to initiating a new research protocol involving human subjects. InfoEd is the electronic online submission system used by the UTMB Institutional Review Board to review all human subject research protocols. All protocols are initiated in Velos, submitted through InfoEd, and then electronically routed to the IRB for review: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/irb/investigator-study-team/working  

  Completion of InfoEd: Guidance on navigating through InfoEd is located, here: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/irb/investigator-study-team/submission-help

  IRB Drop-in Hours/Submission Workshop (on hold): The IRB Office is hosting a series of drop-in workshops to help investigators and coordinators with their submissions in InfoEd. Bring your questions and study information, and staff and computers will be available to work on IRB submissions: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/irb/investigator-study-team/submission-help

• Clinical Research Center (CRC)

  CRC general information: The ITS-CRC provides an environment for conducting complex Phase I – Phase IV clinical trials including PI-initiated and industry-sponsored studies.  Many studies involve pharmacokinetics or research in special populations and orphan diseases.  The ITS-CRC provides comprehensive services including in-patient and exam rooms, nursing, bionutrition, core laboratory, exercise and special procedure rooms, exercise and metabolic equipment, and a DXA scanner: https://its.utmb.edu/enhancing-research/clinical-research-center/about-us

  How to submit a protocol (and forms): https://its.utmb.edu/enhancing-research/clinical-research-center/how-to-submit-a-crc-protocol

  Budgets for studies using the CRC: For studies involving the use of the CRC, please contact Liz Ruiz (ebruiz@utmb.edu)

• Contracts and Agreements

  Industry Contracts: Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and Financial guidance are provided by the Office of Clinical Research, here: https://research.utmb.edu/research-at-utmb/office-of-clinical-research-(ocr)/cdas

  Memorandum of Understanding (MOU) and Data Use Agreement (DUA): The Office of Technology Transfer manages The University of Texas Medical Branch's Intellectual property assets while promoting and encouraging scientific research: https://www.utmb.edu/techtransfer/TechnologyTransfer

  Material Transfer Agreement (MTA): Material Transfer Agreements (MTAs) are required when any research materials are exchanged between UTMB and another entity. MTAs control the terms and conditions under which the recipient scientist and institution may use the exchanged materials for research: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/biosafety/bio-materials-shipping  

  IRB Reliance Agreements (IRB): For information regarding use of a IRB-reliance, commercial IRB, or single IRB, please contact the IRB directly: https://www.utmb.edu/provost/resources/research-regulations-and-compliance/irb/home

  ClinicalTrials.gov Submission: The Department of Health and Human Services (DHHS) requires clinical trial registration and results submission for ALL NIH-funded clinical trials. This includes phase 1 studies, small feasibility studies, and trials that do not involve any FDA-regulated product, such as trials involving only behavioral interventions: https://research.utmb.edu/research-at-utmb/office-of-clinical-research-(ocr)/clinicaltrialsgov

• Resources for Study Visits

  Clinical Research Center (outpatient/inpatient rooms): https://www.utmb.edu/its/enhancing-research/clinical-research-center/about-us

  Investigational Drug Services (IDS): The service consists of an IDS Coordinator, a part-time Pharmacist, and a Pharmacy Technologist. The service is covered by a member of the IDS 24 hours a day. The IDS is currently involved with the drug management of approximately 140 drug studies at UTMB. The service interacts closely with UTMB physicians, nurses, study coordinators, pharmacists, and various drug sponsors involved with clinical drug trials: https://www.utmb.edu/rxhome/investigational-drugs

  ClinCard/ Participant reimbursement: Research participants may be compensated via two mechanisms – Gift Card or ClinCard. Information and polices are located, here: https://research.utmb.edu/research-at-utmb/office-of-clinical-research-(ocr)/clincard

• Coordinator Support Services

  Research Coordinator Support Service (RCSS): The RCSS is an internal resource for the conduct of clinical research comprising a staff of trained research coordinators and nurses who provide clinical research support services to researchers at UTMB spanning the study life cycle from study start-up to study closure: https://research.utmb.edu/rcss

  Monthly Clinical Research Coordinator Meetings: Research Services sponsors Clinical Coordinator Meetings for the purpose of developing the professional skills of UTMB clinical research coordinators, and to promote networking within our research community: https://research.utmb.edu/research-at-utmb/training-development/education-programs

  Regulatory and Study Monitoring Templates (OCR website): Study management documents are located, here: https://research.utmb.edu/research-at-utmb/office-of-clinical-research-(ocr)

• Recruitment resources

  Research Match: ResearchMatch is a nonprofit program funded by the National Institutes of Health (NIH). It helps to connect people interested in research studies with researchers from top medical centers across the US: https://www.researchmatch.org/

  Center for Leading Innovation & Collaboration (CLIC) Inclusion of Older Adults in Clinical and Translational Research: This toolkit comprises a set of power point slide sets (modules) intended to serve as a resource for persons delivering presentations aiming to heighten and facilitate older adult inclusion in clinical and translational research: https://clic-ctsa.org/education/kits/presentation-materials-library-inclusion-older-adults-clinical-and-translational

  UTMB Trials Today/Clinical Trials: Current clinical trials accepting volunteers: https://utmb.trialstoday.org/

  Clinical Research Matching Service: The form below will be used to match researchers, clinicians, and scientists with various research-related resources. Once you complete the form you will be contacted within three business days: https://redcap.utmb.edu/surveys/?s=CW8JRKFJAN

  Community Engagement Studio (CES): The CES is based upon a model developed by the Vanderbilt Institute for Clinical and Translational Research and is designed to serve as a guidance session for health researchers interested in getting feedback from patients or preparing for working in a community setting. Community stakeholders serve on expert panels to provide feedback on various aspects of the proposed or ongoing research project, including the design, intervention, communication materials, participant recruitment strategies, and applying research findings to practice. By working directly with patients and other community stakeholders, researchers are able to do so in a way that is culturally sensitive and in keeping with community priorities, values, and needs. Contact Krista Bohn: krbohn@utmb.edu

  ITS Health Informatics- Research Data Requests (EPIC/EHR data): The Institute for Translational Sciences (ITS) Informatics Team now providing an updated Research Data Request Service https://www.utmb.edu/its/its-informatics-service-center/health-informatics/data-requests

• Data Management

  REDCap: REDCap is a secure web platform for building and managing online databases and surveys. REDCap's streamlined process for rapidly creating and designing projects offers a vast array of tools that can be tailored to virtually any data collection strategy: https://redcapproject.utmb.edu/index.php

• ITS Studios

  Community Engagement Studio (CES): The CES is based upon a model developed by the Vanderbilt Institute for Clinical and Translational Research and is designed to serve as a guidance session for health researchers interested in getting feedback from patients or preparing for working in a community setting. Community stakeholders serve on expert panels to provide feedback on various aspects of the proposed or ongoing research project, including the design, intervention, communication materials, participant recruitment strategies, and applying research findings to practice. By working directly with patients and other community stakeholders, researchers are able to do so in a way that is culturally sensitive and in keeping with community priorities, values, and needs. Contact Krista Bohn: krbohn@utmb.edu

  Innovation & Entrepreneurship Studio: The Studio brings together experienced innovators, UTMB resources, and institutional and community partners to support clients as they navigate the complex ecosystem of information and resources necessary to develop new drugs, devices, interventions, and services: https://www.utmb.edu/innovations/programs-group/entrepreneurship-commercialization-studio

  Clinical Trials Studio: The Clinical Trials Studio is an initiative supported by a multidisciplinary team of accomplished clinical trialists aiming to assist UTMB investigators with beginning and refining their clinical trials. We assist researchers at any career level, and we provide feedback on trials at any stage of development: https://www.utmb.edu/its/enhancing-research/clinical-trials-studio/about-us

  ITS Biostatistics & Bioinformatics Studio: An opportunity for researchers to schedule a studio session to ask questions regarding research study design, generating or retrieving data, guidance with analysis of collected data, and any questions related to biostatistics, bioinformatics, or health informatics. The Studio provides highly qualified experts at NO COST.  The Studio sessions occur on the 3^rd Monday of each month, 1:00pm-2:00pm, 6.110 Research Building 6. Click here https://redcap.link/tqimkiw5 to schedule your session.