Miami CTSI

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CTSI Research Services

The Miami Clinical and Translational Science Institute (CTSI) offers extensive research-related services to support investigators on all UM campuses who are conducting research that has the potential to improve the health of our diverse community.
In cases where costs are associated, the Miami CTSI can help through service credits.

Ask a Research Navigator
Not sure where to start? The Miami CTSI Research Navigator advises investigators on available resources and helps them navigate research-related processes. To contact the Research Navigator click here.

Clinical / Translational Cores

Biostatistics Collaboration and Consulting Core
Support and consultation on research design, biostatistics and novel analytical methods development. Learn more.

Consultation Services and Support

Research Writing Support
A range of writing services is available to help Miller School of Medicine faculty researchers, post-doctoral fellows and graduate students get more grants, publish more peer-reviewed articles and make compelling presentations. Learn more

Novel Translational Methods, Technologies, and Resources
For consultations in the commercialization of technology, intellectual property, starting a company, confidential disclosure agreements, material transfer agreements (MTA) and data transfer agreements (DTA), and Small Business Innovation Research (SBIR)/ Small Business Technology Transfer (STTR) training, contact the UInnovation Office at 305-243-5689.

Data Storage
The Center for Computational Science (CCS) offers data storage for non-PHI data to investigators for research purposes. To make a request, visit http://ccs.miami.edu/ctsi/

De-identification Services
The University Office of Privacy & Data Security, in conjunction with UHealth IT, provides services that can de-identify clinical data sets. All direct identifiers such as name, social security number, medical record number, email address etc. must still be removed or masked.

OneFlorida Front Door
The Miami CTSI is a member of the OneFlorida Research Consortium, which allows its investigators to utilize the OneFlorida Data Trust and research infrastructure and services through its access point called Front Door. From here, researchers can submit a prep-to-research data query, which helps researchers formulate hypotheses and identify trends within targeted populations, or apply to utilize the consortium’s practice-based research network, central IRB and more. Learn More

Regulatory Knowledge and Support
For consultation on how to improve the quality of regulatory adherence in clinical research protocols and assure participant safety through data and safety monitoring planning and implementation, particularly at the time of study development. Learn more.

Research Ethics
For consultations on ethical considerations. Learn more.

Community Engagement and Cultural Diversity
For consultations on conceptual, methodological and analytic issues with research involving racial/ethnic minorities; strategies for recruiting research participants; establishing community research partnerships; disseminating findings to relevant stakeholders, contact Brendaly Rodriguez at 305-243-8433 or BRodriguez@med.miami.edu

Research Compliance and Quality Assurance

  • Study Start-Up Review: These reviews are recommended for inter-departmental/translational research studies, as well as for investigators/research teams who are new to research. We will review the study teams’ processes, forms, etc. prior to enrollment of the first subject and provide you with hands-on guidance. These reviews are intended for studies that are not internally or externally monitored.

  • Study Review: This type of review may be requested for studies already in progress with at least one subject enrolled. We will conduct a review of the conduct of the study and associated documentation. These reviews are intended for studies that are not internally or externally monitored.
  • Mock FDA Audit: An Investigator may request a Mock FDA Audit, where RCQA will conduct the audit to mimic an FDA inspection. Mock FDA Audits are recommended for studies that might be inspected by the FDA.

No more than one review should be requested per department/unit/center at this time. Please contact Helen Miletic ( hmiletic@med.miami.edu /305-243-4306) or myself ( jstamates@med.miami.edu /305-243-4215) if you are interested in any of the above mentioned reviews or if you have any questions.

Need Help?

Email us with a request at CTSIservices@med.miami.edu

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