Miami CTSI

Clinical Research Roadmaps

Guidance for Clinical Research Professionals to navigate through Grant Initiation, Implementation and Close-Out.

The roadmaps are intended to be used as guides. The duration of each process may vary with the complexity of the studies, the requirements of the funding agencies, the experience of the study teams, and the availability of the engaged parties. The roadmaps are accessible on mobile devices. Compatible with most major browsers except for IE8 and below. We welcome your feedback. Please use the "Feedback" button within each window to report inaccuracies or provide information.
Thank You.

Initiating Sponsored Research (Pre-Award) Implementing Sponsored Research (Post-Award)

Directory

Name Contact
Centers for Medicare and Medicaid Services (CMS) http://www.cms.gov/medicare/coverage/IDE/index.html
Clinical and Translational Research Site (CTRS)
formerly Clinical Research Center (CRC)
http://research.med.miami.edu/clinical-research/ctrs(305) 243-5012
Clinical Research Operations and Support (CRORS) See under Executive Dean for Research (EDR)
Clinical Trials Search Tool (CTST) http://uhealthsystem.com/clinical-trials For more information, call the Clinical Trial Information Center 1-800-545-2292
ClinicalTrials.gov https://clinicaltrials.gov/ct2/home
Collaborative Institutional Training Initiative (CITI) www.citiprogram.org/
Congressionally Directed Medical Research Programs (CDMRP) http://cdmrp.army.mil/default
Data Broker Group (Office of Privacy & Data Security) http://privacyoffice.med.miami.edu/data-broker-services/ (305) 243-5000
databroker@miami.edu
Department of Defense (DoD)- Human Research Protection Office (HRPO) http://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.hrpo
Disclosures & Relationship Management (DRM) uresearch.miami.edu/uresearch-services/coi/index.html UDisclose Helpline: (305) 243-0877
Electronic Biomedical Research Application Portal (eBRAP) https://ebrap.org/eBRAP/public/index.htm(305) 243-9109
Executive Dean for Research (EDR) Research Development and Support (RDS) http://research.med.miami.edu/pre-post-award/rds-staff (305) 243-6381
Clinical Research Operations & Regulatory Support (CRORS) http://research.med.miami.edu/clinical-research/crors (305) 243-6381
Food and Drug Administration (FDA) https://www.fda.gov
Grants.gov https://www.grants.gov/
Human Subjects Research Office (HSRO) – University of Miami http://hsro.med.miami.edu (305) 243-3195
InfoEd https://infoed.med.miami.edu
International Conference on Harmonization- Good Clinical Practices (ICH-GCP) http://www.ich.org/products/guidelines.html
Jackson Health System (JHS) – Office of Research www.jacksonhealth.org/clinical-contact.asp(305) 585-7226
JHS Application and Study Calendar:https://jacksonhealth.org/clinical/submission/
JHS Data Requests:https://jhs.perflogic.com/forms/jhs/birt_request.html
JHS Research Policies:https://jetportal.um-jmh.org/sites/clinicaltrials/JHS%20Research%20Policies/Forms/AllItems.aspx
Miami Veteran Affairs Healthcare System (VA) - Research Service - Human Subjects Subcommittee Office Miami Veteran Affairs Research (305) 575-7000 Ext: 3179
Miller Office of Research, Research Education and Innovative Medicine (RIM) http://research.med.miami.edu(305) 243-9614
National Institutes of Health (NIH) http://grants.nih.gov
National Institutes of Health (NIH) eRA Commons https://public.era.nih.gov/commons
Office of Privacy & Data Security Health Insurance Portability and Accountability Act (HIPAA) http://privacyoffice.med.miami.edu/contact Email: privacy@med.miami.edu (305) 243-5000
Toll Free: (866) 366-HUSH (4874)
Fax: (305) 243-7487.
Office of Research Administration (ORA)
Research Compliance and Quality Assurance (RCQA)
Research Electronic Data Capture (REDCap) https://cas.it.miami.edu/research-it/redcap/index.html Email: redcapadmin@med.miami.edu
Research Information Technology (RIT)
Research Pharmacy (305) 243-5185
University Research Informatics Data Environment (URIDE) Email: uride@miami.eduhttp://miamictsi.org/researchers/research-tools/uride
VELOS eResearch http://velos.med.miami.edu (recommended browser Internet Explorer and make sure to disable pop-up blockers)
UDisclose System https://www.uresearch.miami.edu/uresearch-services/udisclose/index.html UDisclose Helpline: (305) 243-0877
Workday http://workday.miami.edu/UDisclose Helpline: (305) 243-0877