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.