Rater Training Guidance
Individuals with a wide range of skill and training routinely administer rating
scales used in clinical neuroscience research studies. The training and certification
methodologies used in clinical trials vary in their level of rigor. There is currently
no accepted standard for the clinical research industry to follow when selecting
and training raters to administer rating scales. Such scales are used as primary
and secondary outcome measures contributing to the registration of investigational
drugs and/or for empirical studies published in peer-reviewed journal articles.Studies
such as these would be better served by an industry-wide guideline.
The purpose of the Rater Training and Certification Recommendations document is
to define terminology and to propose general process recommendations for training,
qualification and certification of raters on clinician-rated scales commonly used
in neuroscience clinical research. These recommendations are intended to provide
a common framework for clinical trial investigators, pharmaceutical companies, contract
research organizations, and other entities to follow, providing a standardized baseline
approach for selecting, training and evaluating raters.