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Data management using DMSys is easy and intuitive. DMSys gives you the flexibility to manage your clinical data according to your needs.

Data entry can be performed in single-form mode or cross-form mode. Single-form mode allows you to enter data for multiple patients for the same Form. Cross-form mode allows you to enter data for multiple patients for different Forms. Data entry can also be performed with interactive range checks that inform the data entry operator when a value entered is outside a preset set of ranges. Second data entry can be performed non-interactively ("blinded") or with interactive verification that informs the second data entry operator when a value entered is inconsistent with the value entered by the first data entry operator.

DMSys maintains a full 21 CFR Part 11 compliant audit trail. The audit trail also includes data entry performance metrics providing a valuable management tool.

DMSys stores any errors found when you run range and logic checks. The error management facility allows you to browse the errors, create queries, track resolution of errors, and make corrections, directly from a single screen. Errors that are queried or corrected are automatically flagged as such.

In addition to creating queries through the error management facility, DMSys' query management function allows you to create independent, stand-alone queries. All queries are managed through the query management function. You can browse existing queries, track their status, and enter corrections, all from a single screen. When printing queries in either a paper or electronic format you have the ability to select queries on numerous criteria, providing almost infinite flexibility. The criteria include investigator site, patient number, the user who created the query, the creation date(s), and query number. Queries can be output to a DMSys report, with the options of one or multiple queries per page, or to a Microsoft Excel file or a customizable Microsoft Word document.

When entering a correction, DMSys displays the current value and you enter the new value and a reason for the correction. If you are making multiple corrections, the Form, record ID, variable and reason for the correction can be carried over from one correction to the next. As with data entry and verification, DMSys maintains a full audit trail for corrections.





 

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