A thorough study site selection, preparation and infrastructure development are integral components of conducting successful clinical research. Site assessments include visits to a potential study site to ensure that the local Principal Investigator (PI) and study team have everything in place to conduct the study according to good clinical practices and applicable laws and regulations. This includes, among others, qualifications and skills of study personnel; facilities and equipment including laboratories and computer systems; record keeping systems; data collection, data entry, and data management capabilities; data analysis capabilities; and information technology systems such as availability and reliability of Internet connections.
To facilitate on-site evaluations, GlaxoSmithKline (GSK) Biologicals requested assistance from AMP to develop a Site Assessment Tool (SATool) to ensure that the data collected during site visits are complete and comparable across sites.
As such, AMP has designed and developed a tool allowing 1) a comprehensive multilevel questionnaire (central level, demographic site level, hospital level, health centers level, community level) and 2) the direct comparison of several study sites based on pre-defined requirements and risks. As part of the SATool, all operational, scientific/technological, economic and cultural issues and policies have been considered that might have an impact on site performance, and this for each level assessed.
The SATool has been initially designed to help with the comparison between potential sites for vaccine introduction studies, including sites evaluating safety and effectiveness.