In order to mitigate risks without having to make costly site visits, clinical trial sponsors require oversight capabilities that proactively identify site training needs. This is even more important as clinical trials become increasingly complex, especially since the average number of investigative sites per trial grows year after year.
Effective Rater Training Drives High Data Quality
Progressive, consistent delivery of study-specific rater training reinforces learning, especially when flexible options ― including interactive web-based remote training, on-device training, investigator meetings, and onsite proficiency learning / enforcement ― are made available.
Such reinforcement is particularly important for studies that require collection of clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) data, as inconsistent ClinRO and PRO measurements result in poor data quality and missing data, which may compromise interpretation of study outcome data.
Implementing standardized assessments electronically mitigates the risk of missing data and data errors. But effective rater training in clinical trials is warranted to ensure data quality and enrollment of the appropriate patients into studies.
Effective rater and subject training is a key contributor to demonstrating therapeutic efficacy and safety as it ensures that each electronic Clinical Outcome Assessment (eCOA) is consistently administered across sites. By coupling rater training to the eCOA interface, raters are trained by the study FPI and training certification is insured before completion of the first study visit where critical screening and/or baseline data is collected.
On-Device, On-Demand Rater Training Helps Sites Succeed
On-demand, interactive modular training is vital, especially in overcoming the time lapse that often occurs between investigator meetings and first patient in as well as site staff turnover issues. Rater training deployed on the study device or web can be accessed on-demand, and gating can be used to restrict assess such that only trained raters or subjects can complete eCOA assessments.
Linking rater and subject training on the same data capture platform enables:
- Improved training quality
- Ease of use
- Cross-talk between eCOA and rater environments
- Single sign-on for all functions
In addition, utilization of electronic media for qualification of raters enables a fully automated means for raters who are beginners to receive full training versus raters who are more experienced to receive a more abbreviated form of training. This eases the burden on the sites, while accomplishing the goal of training assurance study-wide
Automated quizzing and/or gold score testing for rater certifications and training should be provided, including real-time rater reporting with certified, trained, remediated and failed raters as well as training expiration dates. Since electronic rater training can be integrated into the standard site workflow with minimal disruption, staff can focus on maintaining efficient and consistent trial operations.
Sponsors who develop and implement effective rater training strategies not only help investigative sites succeed, they recognize significant benefits in standardizing and improving clinical trial data quality to support important safety and efficacy endpoints.
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Up next in the Clinical Site Optimization series, we look at accelerating trial enrollment and optimizing compliance by improving the patient experience. Be sure to read Part 1 of the series for details on how to “Identify the Most Historically-Productive Sites.”
Susan M. Dallabrida, PhD is the Vice President of Clinical Science and Consulting Services at ERT
- Treweek, S. ‘Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial,’ Trials. 2013; 14: 436. Published online 2013 Dec 18. doi: 10.1186/1745-6215-14-436