SYSTEM AND METHOD FOR ENSURING INTEGRITY OF CLINICAL TRIAL RESULTS

摘要

The system and method utilize the inter-relationship of items in a psychological instrument or instruments and have been demonstrated empirically to detect problematic conceptualizations of constructs. Scores from the instruments are submitted for review. The scores are analyzed by a computer program that compares item level scores with expected values based on the item inter-relationships. If inconsistencies are discovered a flag is generated. If inconsistencies are deemed actionable then remedial action or contact is scheduled with the site-based clinician or “rater” who conducted the patient assessment using the instrument or instruments. The site-based clinician is contacted and an information exchange about the case occurs in which the site-based clinician provides an overview of symptom presentation. This symptom presentation is then matched to the item level scores on the instrument to determine if it was scored in a manner consistent with the conceptual basis for the items.