Quality control and quality assurance of cognitive data in dementia clinical studies and trials

Ryoko Ihara

Department of Neurology, Tokyo Metropolitan Geriatric Hospital

Recently, the number of clinical studies and trials that focus on preclinical and prodromal Alzheimer’s disease in which the rate of cognitive change is small is increasing.　The importance of quality control and quality assurance (QC/QA) of cognitive data is also increasing.　QC/QA of cognitive data consists of providing comprehensive procedures manual and training before study visits, and audio review and feedback of cognitive testing during the study besides general QC/QA procedures.　In Japan, since only a few clinical sites continuously conduct cohort studies, many clinical sites have only one or a few psychometricians who work mainly for clinical practice, and sometimes even some sites ask for the dispatch of temporary examiners from a site management organization company at the start of the study.　Thus, internal QA process and education for psychometricians often do not work well within a site.　In such a situation, audio review in multicenter studies and trials serves as not only QC/QA but also education for psychometricians.　In expectation of consistent and better performance of early career psychometricians, central audio review is incorporated also into academic cohort studies on a trial basis.

Address correspondence to Dr. Ryoko Ihara, Department of Neurology, Tokyo Metropolitan Geriatric Hospital (35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan)