Under the trial, staff are offered contracts in line with the average hours per week they work.
About 90% of the trial staff were from Guinea, a country where no clinical research had been carried out before.
These include the trial staff, clinical trial staff, chronic lateness, rudeness or indifference by some staff.
Footage of the kits was captured by trial staff.
We could not assess whether trial staff adhered to protocol instructions, which may have impacted PRO compliance rates.
It is therefore concerning that recent evidence indicates trial staff perceive PRO data collection guidance to be inadequate [14].
There is no substitute for high PRO completion rates, and trial staff should routinely be reminded of this as a quality assurance measure.
Between May 2008 and May 2014, more than 32,000 people were involved in various activities held by Scottish Beaver Trial staff.
For supervised interventions (n = 42), this information was routinely collected by program or trial staff based on attendance, while unsupervised interventions (n = 4) relied on self-reported participant exercise logs, or data collected via the phone each week.
The trial was double-blinded, so neither trial staff nor participants knew to which gel group participants were allocated.
The reports systematically documented anonymous information that trial staff were either told or overheard at the clinics or in the community.
