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:
- Physical spaces in the centre were clean and free from clutter/noise
- The environment was secure, with swipe card access to key areas
- OxCRF has the benefit of being outside the main hospital but within
easy reach in case of emergency
- Workplace culture was supportive, collaborative and friendly
- Teamworking skills were well developed
- Communication between COV-CHIM study team members and study
participants was clear and respectful
- Inter-team communication between COV-CHIM study team members and OxCRF
staff was unambiguous and well-structured
The three tasks observed involved variable numbers of study staff at
different times of day:
- Inoculation (time observed: 12:00), six study team members involved:
two study nurses collected the virus, two study nurses and 1 study
doctor undertook the task and one study nurse acted as a runner and
stayed in the ante-room adjacent to the participant’s room.
- Throat and nose swab (time observed: 14:00): three team members were
involved: one study nurse in the room to undertake the procedure and
two study nurses to check and store the samples
- Transfer to CT scan (time simulated: 14:30): two study nurses
accompany participants to the scanner. The simulation involved another
nurse acting as the participant. The route took 11 minutes to walk, 20
people were passed at less than the contemporaneous recommended safe
distance for COVID (2 metres) for less than ten seconds (i.e.
extremely low risk encounters). The simulation was conducted much
earlier in the day than study transfers would usually occur (scans are
routinely done in the early evening), and all staff reported that
there were far fewer encounters with bystanders after normal working
hours.
Latent safety threats were identified in three broad areas: rule
breaking and normalisation of deviance, standardisation (including use
of checklists), and work system design.