During a Phase III schizophrenia study our algorithms detected a logical inconsistency in the data. In this instance Cronos contacted the site and following an in-depth discussion determined that it was very unlikely that the scores submitted were related to the actual patient presentation discussed. In addition to the rater having a seemingly limited understanding of the scale, there were insufficient details provided about the actual patient.
The Sponsor was notified immediately and a CRA was sent to the site to conduct a more thorough investigation. Through this investigation it was determined that there were significant protocol violations and documentary irregularities occurring at the site and the investigation led to the closure of the site. While one site may not result in the failure of a trial, the potential risk to the overall data validity of the study is compromised.