Poster Presentations Details

Poster Presenter

Rebecca Hummel

Quality Manager
CNS Healthcare
United States

Redundant training continues to be a significant and unnecessary burden for the research sites that are otherwise most efficient and proven to be highly successful at conducting clinical trials, specifically those with years of experience in clinical trials.

CNS Healthcare Orlando, Jacksonville, Memphis. Initial rater training required by a protocol and performed during 2015 at these sites.

Chart 1 shows total number of raters across the three sites who received initial rater training for a protocol in 2015. There were 28 total raters. Of those 28, 16 were required to do repeat training on rating scales during the year. Chart 2 shows the number of times (greater than one) a rater had to complete training for the same scale. Forty three different times a rater completed training on the same scale twice, and twenty three times a rater completed training on the same scale three times. This goes all the way up to three different people who completed training on the same scale ten different times. In total, repeat training was done 210 times across 16 individuals. And this data is for the year 2015 only – the same process repeats itself continuously throughout each year. Chart 3 provides an example of one rater, the scales this rater was required to repeat training on, and the number of times the repeat training was required. This particular rater repeated training on 13 different scales, some multiple times, for a total of 35 repeats. Again, this is one individual rater for one calendar year. As seen in Charts 4 and 5, the Columbia Suicide Severity Rating Scale© (C-SSRS) is an example where progress has been made, although accidentally. Because there is only one rater certification available, and one certificate given (that lasts for a period of two years), sponsors sometimes accept a rater’s current certificate instead of requiring the rater to repeat the training ad infinitum. For eight protocols, new C-SSRS training was required – once for 3 individuals, twice for 3 individuals, three times for 5 individuals, four times for 2 individuals, and five times for one individual. However, the sites participated in an additional 12 protocols during this time that required other initial training but the C-SSRS training was not required if the rater had a current certificate.

Repeat training was done a total of 210 times at these three sites over the course of one calendar year. If we assume an average training time of 30 minutes (and it is very often more – some of the scales require web-based modules and then recorded live interviews to be assessed by the rater certification company), that is 105 hours (or over 13 days) taken from activities such as recruitment, completing subject visits, entering EDC data. These are hours added on to the time it takes to complete the lifecycle of a clinical trial.

T 36: Reduce Training Redundancies to Improve Clinical Trial Efficiency

Poster Presenter

Rebecca Hummel

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