Clinical Research Guidelines and Process Roadmap
Text version
| Design and Planning |
Start-Up |
Conduct & Monitoring | Analysis & Reporting | Closeout |
|---|---|---|---|---|
| Step 1 | Step 2 | Step 3 | Step 4 | Step 5 |
|
Activities Include: Protocol Development Feasibility Budget Development Medicare Coverage Analysis Establish Data Management |
Activities Include: Clinical Trial Agreement Insurance/Indemnity Clinical Trial Registration Site Initiation* Maintenance of Regulatory Files* Delegation of Authority* Completion of 1572 (FDA)* |
Activities Include: Recruitment of Research Participants* Enrollment of Participants* Financial Management Monitoring Quality Assurance |
Activities Include: Data Analysis Results & Data Sharing Sponsor Reporting Clinical Trial Reporting |
Activities Include: Study Closeout* Site Closure Archive Regulatory Files |