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The Buffalo Neuroimaging Analysis Center (BNAC) has created an enterprise software system, developed and validated accord to the Food and Drug Administration (FDZ) guidelines. This system encapsulates most study-related standard operating procedures (SOP) and protocols into software rules and is closely coupled with a central transactional relational database. The system automates as much as possible, including verification of shipment completeness and corrections, verification of protocol adherence, and database updates (with supervision of trained operators).
 

This software automates most data collection performed by including domain-knowledge of analysis procedures and files, thus removing the possibility of human data entry error. Furthermore, the system includes a number of fail-safes and consistency checks – automated range/consistency checks are performed routinely and manual operator checks can be enforced by the software at appropriate points (based on analysis-specific or study specific policy).
 

The system also provides a variety of methods for data export and automated reporting and is capable of exporting in most standard formats (SAS, SPSS, Excel, SQL, and CSV). This can be easily extended to support other formats as well. Reports/exports can be set to occur at regular intervals and/or at given milestones (e.g., baseline completion, study completion).