Skip Menu Navigate: Select to Navigate... - Research Integrity & Regulatory Affairs - ClinicalTrials.gov Info - Regulatory Affairs Guidance and Services - Investigational New Drug Application - Investigational Device Exemption Application - Regulatory Affairs Resources - DATA Safety Monitoring Board -- Overview -- DSMB Charter -- Submission Process -- Study Information Form Research Integrity & Regulatory Affairs ClinicalTrials.gov Info Regulatory Affairs Guidance and Services Investigational New Drug Application Investigational Device Exemption Application Regulatory Affairs Resources DATA Safety Monitoring Board Overview DSMB Charter Submission Process Study Information Form Regulatory Affairs Resources Template Documents and FormsThese template documents are meant to serve as a guide. We recommend that you reference the regulations and applicable guidance documents as you prepare your submissions. Please contact our team at vsrosemo@utmb.edu with any questions or suggestions.IND TemplatesGeneral Mailing Instructions & FDA AddressInitial IND Application IND Process GuideIND Exempt Decision TreeIND Exemption LetterIDE TemplatesIDE ApplicationIDE Process Guide and InstructionsIDE Investigator AgreementSNR/NSR Information SheetReport TemplatesAnnual Report TemplateFinancial DisclosureGuide to Financial DisclosureFDA FormsForm 1571 - IND Application Cover FormForm 1572 - Investigator’s StatementForm 3674 - Investigator CertificationForm 3454 or 3455- Financial Disclosure