Project Lifecycle
1. Development
- Concept/Feasibility
- Study Design
- Budget Development
- Oversight Plan
- Vendor Selection & Vendor Audits
- Recruitment Plan
2. Submission Process
- FDA Submission of IND/IDE
- IRB Initial Submission
- Site-specific Review Committees
- Overall Submission Timeframe
3. Study Start-Up
- System Development & Validation
- Investigational Product
- Clinicaltrials.gov Registration
- Site Activation
- Site Qualications
- Site Level Agreements
- Site Initiation
4. Study Conduct
Sponsor
- FDA Reporting
- Data Management
- Drug Accountability
- Pharmacovigilance
- Trial Master File
- Financial Management/Contracts
- DSMP & DSMB, Monitoring
- Auditing/Inspections
- Clinicaltrials.gov
- Biospecimen Management
Site
- Non-compliance
- Under performing Sites
- Site Termination
5. Closeout
- FDA Reporting
- Site Closeouts
- Investigational Products
- Results: Clinicaltrials.gov
- Publications
- Fiscal
- Database Locks/Statistical Closeout
- Specimens
- Study Report
- Ongoing Sponsor
- Responsibilities/Archiving