Abstract
Electronic data capture of case report forms, demographic, neuropsychiatric, or clinical assessments, can vary from scanning hand-written forms into databases to fully electronic systems. Web-based forms can be extremely useful for self-assessment; however, in the case of neuropsychiatric assessments, self-assessment is often not an option. The clinician often must be the person either summarizing or making their best judgment about the subject’s response in order to complete an assessment, and having the clinician turn away to type into a web browser may be disruptive to the flow of the interview. The Mind Research Network has developed a prototype for a software tool for the real-time acquisition and validation of clinical assessments in remote environments. We have developed the clinical assessment and remote administration tablet on a Microsoft Windows PC tablet system, which has been adapted to interact with various data models already in use in several large-scale databases of neuroimaging studies in clinical populations. The tablet has been used successfully to collect and administer clinical assessments in several large-scale studies, so that the correct clinical measures are integrated with the correct imaging and other data. It has proven to be incredibly valuable in confirming that data collection across multiple research groups is performed similarly, quickly, and with accountability for incomplete datasets. We present the overall architecture and an evaluation of its use.
Highlights
Mental health research conducted on human subjects involves a rich set of clinical, neuropsychological, and sociodemographic assessments
Clinical trials organizations implement continuing oversight processes with regular audits of the paper forms, to ensure that data are being collected correctly; effective, source data verification (SDV) creates an incredible cost in personnel time both on the part of the local research team and the study as a whole
The Mind Research Network (MRN) has developed a software tool for the real-time acquisition and validation of clinical assessments in remote environments: The clinical assessment and remote administration tablet (CARAT). We have developed this tool on a Microsoft Windows PC tablet system, and it has been used successfully to collect and administer clinical assessments in several large-scale studies
Summary
Mental health research conducted on human subjects involves a rich set of clinical, neuropsychological, and sociodemographic assessments. 5. Generic engine useful for any assessment and arbitrary visitbased groupings of assessments: The CRF metadata, including the questions, possible answers, data validation and required field information, and identifiers for upload to the database, had to be understood and expandable.
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