Facility
Site Requirements:
- Dedicated exam rooms.
- Dedicated office for UACR staff and study related files.
- Locked and limited access drug and supply storage facilities.
- Basic lab and equipment facilities for specimen and diagnostic collection. All lab and equipment facilities must be calibrated and certified as required by law.
- Refrigeration and freezer capabilities or accessibility specific to the needs of the study drug.
- Dedicated area for storage of study binders that has limited access and is secure.
- Dedicated area for Sponsor monitoring visits that is well lit, comfortable and appropriate for monitoring staff.
- Assign/ dedicated staff person trained as the Study Coordinator.
- Assign/ dedicated technician/coordinator to conduct study related lab requirements for all assigned studies
- Maintain a system for quickly identifying patients by diagnosis or condition (preferable a dedicated staff member who could conduct chart reviews during pre-screening/screening process for qualified patients).
Site Management:
UACR provides the following:
- Assignment of a dedicated Clinical Research Project Manager/ Director to oversee the clinical operations.
- Marketing and business development of UACR and its capabilities for all upcoming research trials and opportunities
- Complete Study feasibility questionnaires
- Budget Negotiations with Sponsor/CROs
- Incorporating UACR specific Standard Operating Procedures (SOP’s) and/ or incorporating/ utilizing only, Sponsor’s SOPs
- Study start-up activities to include collecting and processing regulatory documentation.
- Subject recruitment strategies
- CRF Completion and Query Management
- Conducting on-site independent QA protocol audits for QA, sponsors and FDA inspection preparation and training purposes