Clinical Research Center
Our Research Process
Conducting a clinical research study can be complex. Here you will find a detailed outline of the UH clinical research process that walks you step-by-step through our process from concept development to study closure.
UH Research Roadmap
Navigate the research process in detail with directions to specific regulations, policies, forms, tools, templates, contact points, education and training. Use the roadmap as a checklist for every study to make sure that all of your bases are covered as you move through the research process.
- 1. Getting Started
- 2. Required Reviews & Approvals
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- When is IRB Required?
- PHI for Research & Data Security
- Conflicts of Interest
- Contracts & Agreements
- Department Review & Additional Required Reviews
- Coverage Analysis
- Submit to the FDA
- Submit to the IRB
- 3. Study Start-Up
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- Source Documents
- Regulatory Binder
- Site Initiation
- Grant Account Set-up & Award Management
- Research Billing
- 4. Study Conduct
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- ClinicalTrials.gov Registration & Result Reporting
- Investigator Responsibilities & Oversight
- Protocol Compliance
- Protocol & Consent changes
- Adverse Events, Unanticipated Problems & Protocol Deviations
- Quality Assurance & Monitoring
- IRB Continuing Review & Other Annual Reports
- 5. Study Close