Problem: Investigators Unresponsive to Standard Remediation Procedures Mid-Study

Data-monitoring during Study Z identified several investigators that did not appear to be responsive to standard training and remediation. The issue was in relation to the assessment of symptoms by non-standardized clinical assessments in opposition to what is required in global clinical trials - adherence to a structured clinical interview guide and the use of standardized rating criteria in a systematic way for each patient assessed. The issues were detected and confirmed using proprietary data-monitoring algorithms. The intervention for this case involved the immediate discontinuation of recruitment at the sites and enhanced one-to-one training with ProPhase and CROnos expert rater training staff.

Result: Data-integrity was maintained for the study and data quality at the site was maintained.