17 Feasibility & Site Selection
17.1 Goal
Identify sites capable of conducting the trial effectively and in compliance with protocol requirements.
17.2 Feasibility Assessment Domains
- Patient population
- Investigator experience
- Staff availability
- Facilities and equipment
- Competing trials
- Recruitment timelines
17.3 CRA Role
- Review feasibility questionnaires
- Participate in site qualification visits (as applicable)
- Identify potential risks or capacity gaps
NoteOncology-Specific Considerations
- Access to eligible patient population by tumor type/stage
- Availability of imaging and central lab workflows
- Experience with complex protocols and amendments
NoteVaccine Trial Considerations
- Access to large eligible populations to support rapid enrollment targets.
- Demonstrated ability to recruit healthy volunteers or target populations efficiently.
- Capacity to manage high visit volume and protocol-driven vaccination schedules.
- Experience with vaccine storage, handling, and cold-chain requirements where applicable.