Sponsors and CROs employ CRAs to monitor clinical study sites. Because most site monitoring is done in the field, it is challenging for study managers to know and understand if CRAs/monitors are conducting their duties effectively and efficiently. Study managers have even less contact with home-based, regional CRAs.
Study managers can measure CRA performance by the volume of CRF pages reviewed, data query rates, visit reports, and feedback from site and project staff. However, these measures provide only ‘indirect data’ on how CRAs actually conduct study visits. Many study sponsors therefore employ co-monitoring/oversight visits to directly evaluate CRA performance and facilitate training.
The following process can help to achieve successful co-monitoring/oversight visits: