Translating research discoveries into new drugs, diagnostics, and therapies is one of the primary goals of WMRAD. Access to advanced technologies is crucial for biomedical research to succeed, and WMRAD has developed an impressive array of technical cores that support research in molecular imaging, early phase clinical research capabilities, and pharmacokinetics and genomics, to name but a few. Additionally, the administrative departments and service cores of WMRAD assist investigators in submitting and managing regulatory affairs and contracts, filing patents, credentialing, and clinical trial recruiting and monitoring.
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
Study Monitoring
- Site Management
- Source Documentation
- Site Personnel responsibilities
- Questions & Recommendations
Facility Capabilities
- Laboratory
- Imaging
- Hospital Services
- Infusion Centers
Investigator Obligations
- Informed Consent
- Patient Recruitment & Retention
- Investigator Study File
Clinical Trial Management Software
- Protocol Compliance
- Subject Management
- IRB Reviews Management
- Financial Reporting
Study supplies & External Vendors
- eCRFs, e-learning module
- Diagnostic Certification and Adjudication process
- Laboratory Requirements
- Treatment Supply
- IVRS
Site File
- Investigator Study Files
- Study Logs
