What are the criteria for selecting and qualifying research sites?
The criteria for selecting and qualifying research sites are one of the key elements in the planning and successful conduct of any clinical or observational study. Research sites are responsible for direct contact with study participants, conducting procedures in accordance with the protocol, and ensuring the quality and completeness of data. Therefore, proper site selection has a direct impact on recruitment timelines, patient safety, and the reliability of study results. The site qualification process should be strategically planned and based on both formal and operational criteria.
The primary criterion for site selection is its experience in conducting clinical or observational studies, preferably within the relevant therapeutic area. This includes reviewing previous projects, the number of studies conducted, familiarity with ICH GCP principles, and the experience of the research team—particularly the Principal Investigator. The professional qualifications of the entire study team are crucial, including valid medical licenses, clinical experience, and participation in GCP and protocol-specific training. The site should have a stable team, including study coordinators, research nurses, and adequate administrative support to ensure efficient project execution.
Another key area of assessment is the site’s recruitment potential. The sponsor evaluates the patient population treated at the site, the availability of participants meeting inclusion and exclusion criteria, and historical recruitment performance in similar studies. The quality of medical documentation and the IT systems supporting patient identification and tracking are also important. A realistic assessment of recruitment capabilities helps prevent delays and the need to activate additional sites at a later stage.
Infrastructure and access to appropriate technical facilities are also critical qualification elements. This includes the availability of examination rooms, procedure rooms, diagnostic equipment, laboratories, and appropriate storage conditions for the investigational medicinal product, including compliance with temperature and security requirements. The site must be capable of performing all protocol-required procedures without placing excessive strain on routine medical care.
Formal and regulatory aspects are equally important. The site should have experience working with ethics committees and regulatory authorities, as well as the ability to prepare required documentation in a timely manner. Compliance with data protection regulations, internal quality procedures, and readiness for audits and inspections are also assessed. In clinical trials, the site’s ability to operate in accordance with GCP principles and maintain complete source documentation is essential.
The site qualification process often includes a site qualification visit (SQV) or feasibility visit, during which the Sponsor or CRO verifies the site’s declared capabilities in practice. This allows for assessment not only of formal compliance, but also of team engagement, communication, and organizational readiness to initiate the study.
A well-executed process for selecting and qualifying research sites significantly increases the likelihood of smooth study conduct, high data quality, and participant safety. It is a strategic decision that pays off at every stage of the project—from the enrollment of the first patient to the final study report. If you want to be confident that selected sites truly meet the needs of your study, consider consulting our experts—we can help select and verify sites in a safe, efficient, and regulator-compliant manner.
