Observations
Overall observations revealed a high performing CRF with good collaborative leadership on site, and a clear focus on safety for participants and staff involved in clinical trials. Observations of general work activities in OxCRF revealed the following facilitators to safe practice:
The three tasks observed involved variable numbers of study staff at different times of day:
Latent safety threats were identified in three broad areas: rule breaking and normalisation of deviance, standardisation (including use of checklists), and work system design.