Site selection is a rigorous process in conducting clinical trials.
Factors that should influence investigator site selection include:
- Site experience (clinical research and therapeutic area)
- Site personnel skills and abilities
- Site staffing, resources, workload and time commitments
- Access to targeted population with the required eligibility criteria
- Subject diversity requirements
- Technical facilities and equipment
- Ethical review committee policies and procedures
- Institutional legal procedures
- Site training and standard operating procedures
- GCP compliance
- Site source document and data collection procedures
- Site security and storage facilities
- Site selection decision making process
- Role and accountability of CRA in managing site and subject enrollment