The Institute for Translational Sciences Enhancing Research Clinical Trials Studio Areas of Expertise Areas of Expertise Toggle navigation About Us Areas of Expertise Submitting a Research Project e-Library For more pages, click the Navigation Menu above Our areas of expertise include: Clinical Trials Studio Building Strong Translational Research Skills & Teams Training and mentoring the clinical trials workforce Identifying collaborators Enhancing grant applications Completing Regulatory Requirements Creating informed consent forms Assistance with IRB applications Applying for INDs and IDEs Registering in ClinicalTrials.gov Utilizing NCATS, UT System, & ITS Resources NCATS's Trial Innovation Network - A collaborative initiative aiming to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies. The network focuses on operational innovation, operational excellence and collaboration while leveraging the expertise, diversity and broad reach of the CTSA Program. Its features include: a single institutional review board system, master contracting agreements, quality-by-design approaches, and a focus on evidence-based strategies to recruitment and patient engagement. UT System's Clinical Trial Express - An initiative established to provide an efficient and scalable centralized operating model for launching and conducting multi-site clinical trials. ITS's Clinical Research Center - A physical facility on the UTMB campus that provides comprehensive clinical research services and expertise, an optimal setting for controlled studies by translational and clinical investigators, and cost-effective state-of-the-art laboratory equipment and instruments Creating & Managing Clinical Trials Designing rigorous studies Developing biostatistics Designing research protocols Utilizing biomedical informatics Forming recruitment and retention plans Conducting multi-site clinical trials Adhering to research ethics Integrating special populations Engaging communities Communicating results Clinical Trials ToolkitProject Design ToolsClinical Research FormsEthics PamphletIND Application to FDA TemplateIDE GuidanceIDE Application to FDA TemplateProject Development ToolsClinicalTrials.gov InformationUTMB Protocol TemplateNIH Protocol TemplateNIH/FDA e-Clinical Writing ToolRegulatory Submission ToolsIRB Application GuidanceUTMB IRB Informed Consent Form TemplateDSMP TemplateBudgeting ToolsCDAs/Contracts/FinancialsClinCardStudy Recruitment and Retention ToolsResearch MatchSpecial Populations Coordinating Center