UTMB Home Research Resources Research Services Office of Clinical Research Clinical Research Regulatory Guidance Clinical Research Regulatory Guidance Office of Clinical ResearchThe Office of Clinical Research (OCR) provides regulatory guidance to Principal Investigators and their research personnel. Guidance is available for a host of regulatory concerns including: IND/IDE requirements Informed consent document requirements IRB and FDA submission requirementsAdverse event and unanticipated problem reporting requirementsRegulatory binder maintenance requirementsCT.Gov Database Access and guidanceRequest a new CT.gov account by contacting Lori Simon. You will affiliate with UTexasGalveston as the organization. Federal Regulatory Guidance Federal Regulatory Guidance CLINICALTRIALS.GOV CLINICALTRIALS.GOV FDA CLINICAL RESEARCH GUIDANCE DOCUMENTS FDA CLINICAL RESEARCH GUIDANCE DOCUMENTS INVESTIGATIONAL NEW DRUG APPLICATION TEMPLATE INVESTIGATIONAL NEW DRUG APPLICATION TEMPLATE INVESTIGATIONAL NEW DRUG ANNUAL REPORT TEMPLATE INVESTIGATIONAL NEW DRUG ANNUAL REPORT TEMPLATE INVESTIGATIONAL DEVICE GUIDANCE INVESTIGATIONAL DEVICE GUIDANCE Institutional Regulatory Guidance Institutional Regulatory Guidance CRC SUBMISSION GUIDANCE IRB SUBMISSION IHOP POLICY ON CONDUCT OF A CLINICAL INVESTIGATION Records Retention Guidelines OCR Email Addresses CDA / NDA processing requests CTA / budget / protocol Amendments OCR Finance General inquiries / questions OCR nav-bar OCR Home CDAs/Contracts/Financials Clinical Research Forms ClinCard Information Recruitment Regulatory FAQs ClinicalTrials.gov Information ClinicalTrials.gov Resources ClinicalTrials.gov Definitions Investigator andGrants Administrator ToolsGrants Management ResourcesEducational Resources & PresentationsPreAward ToolkitPostAward ToolkitFormsResearch Blog Save