Training and certification of raters is not enough; there needs to be close surveillance of the data to ensure accuracy and monitor for rater drift and other inaccuracies in the administration or scoring of a clinical assessment. The CAT group can employ a variety of surveillance solution in a risk-based monitoring approach to ensure the highest quality of data coming from clinical assessments.
- Source document review: For key inclusionary or efficacy scales, our clinicians will obtain the source documents from the sites and review the documents for assessment or calculation errors, sufficient clinical notes to warrant the scoring, and other checks that point to variability or inaccuracies in the assessment.
- Audio or video surveillance of the assessments: The CAT group can deploy audio or video devices to sites to record the key inclusionary and/or efficacy assessments with the subjects. Our centrally calibrated clinicians can then perform an independent or confirmatory review of the assessment to ensure that scoring/administrative conventions were followed and ensure proper interview techniques were employed. This ongoing surveillance of the assessments is the most comprehensive and effective method to reduced variability in the data.
- Subject eligibility review: In addition the surveillance techniques above, the CAT clinicians can partner with Medical Monitoring to do a comprehensive and holistic review of patient eligibility. This approach can combine automatic EDC data flags, source document review, and audio/video surveillance with specialized patient eligibility forms and other tools that will aid in the holistic review of patient eligibility, leading to assurances that the appropriate patients are enrolled in your clinical study.
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