Protocol/IB Review
- Rationale
- Study Objectives
- Study Design
- Study Procedures and Assessment Schedule
- Endpoints
- Inclusion/Exclusion Criteria
- Temporary Treatment
- Discontinuation
- Definitive Treatment Discontinuation
- Investigational Product Information
- Concomitant Medication
- Study committees
- Special assessments
- AE/SAE Definition and Reporting
- Protocol Deviations
Site File
- Investigator Study Files
- Study Logs
- IP Label Pre-op Dose Memo
Investigator Obligations
- Informed Consent
- Patient Recruitment & Retention
- Investigator Study File
Study supplies & External Vendors
- eCRFs, e-learning module
- Diagnostic Certification and Adjudication process
- Laboratory Requirements
- Treatment Supply (Aptuit)
- IVRS
Study Monitoring
- Site Management
- Source Documentation
- Site Personnel responsibilities
- Questions & Recommendations
Facility Capabilities
- Laboratory
- Imaging
- Hospital Services
- Infusion Centers
