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Data Quality Monitoring in Clinical Trials

This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. Case examples of current data quality methodology are presented and discussed. Perspectives of pharmaceutical companies and trial sites regarding data quality monitoring are presented. Potential future developments in CNS data quality monitoring are described. Increased utilization of biomarkers as objective outcomes and for patient selection is considered to be the most impactful development in data quality monitoring over the next 10 years. Additional future outcome measures and patient selection approaches are discussed.

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.