Research Navigation and Regulatory Assistance

get started on your research journey

Need help navigating the complex landscape of research regulations?

Whether you are a research team aiming to navigate the intricate UF research landscape or seeking guidance in the regulatory and compliance environment, the CTSI Service Center offers a comprehensive range of services to support your endeavors. From IRB support to ethics consulting and quality assurance, the CTSI can support all stages of research.

CTSI connect

How can we help?

The CTSI Service Center provides a range of services that help research teams navigate the UF research landscape and the regulatory and compliance environment, including:

IND, IDE, IRB, FDA, CLINICALTRIALS.GOV

Regulatory Assistance

Our research project navigators collaborate with our Regulatory Knowledge and Support program, providing comprehensive assistance for researchers in meeting regulatory and compliance requirements, from IND and IDE submissions to UF Institutional Review Boards and ClinicalTrials.gov. Our tiered support services streamline the preparation of submissions, offer toolkits for FDA inspections, and furnish templates for high-quality clinical research studies.

Quality Assurance

CTSI quality assurance experts offer guidance in Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Lab Practice (GLP) through consultation, quality audits, standard operation procedures (SOP) development, batch releases, and training. Our systematic approach ensures compliance and quality standards for investigators, covering various aspects of projects, services, and facilities.

Ethics Consulting

Our experts can also consult on ethical issues in biomedical research design and conduct. Services cover a wide range of issues, including protocol design, participant selection, informed consent, conflicts of interest, privacy, genetics research, and more, ensuring ethical considerations throughout the research process.

Multisite Study Support

As a catalytic hub for clinical research, we connect investigators throughout the UF+FSU CTSA hub to several resources available to support and participate in multisite studies, including the Trial Innovation Network’s SMART IRB, and the OneFlorida Clinical Research Consortium.

Participant Advocacy

Do you need assistance planning for the protection of the validity and integrity of your research data? Want training for your staff or research participants about applicable ethical principles, regulations, and guidelines? Are you a research participant who has questions? Whether you’re an investigator, study staff, or participant, we provide assistance in planning for data protection, offer training on ethical principles, regulations, and guidelines, and pursue risk reduction and health enhancement for volunteers.

ClinicalTrials.gov Header

Ensure compliance and enhance visibility with ClinicalTrials.gov

ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The purpose of ClinicalTrials.gov is to provide information about clinical research studies to the public, researchers, and health care professionals.

Get started with our team

Get started with CTSI Connect

CTSI Connect is your gateway to seamless research excellence! Connect is the all-in-one front door to the myriad research services offered at the UF Clinical and Translational Science Institute. Streamlining access, fostering collaboration, and enhancing efficiency, this innovative service ensures a unified and comprehensive approach to elevate your research endeavors