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TrialMaster Export Utility
Submission-Ready Data in Less Time
The data captured in a data management system, whether via EDC, or external system imports (e.g. ePRO, labs etc.), once cleaned and monitored, will ultimately be exported to datasets for analysis and/or submission. Statisticians and programmers devote a large amount of time and effort to map and transform clinical data from a data model optimized for data entry, cleaning and monitoring to the domains required for data analysis and reporting. The TrialMaster™ data export utility is a drag and drop tool allowing you to define export data domains, map and transform the data collection data model to the export domains, and map to industry standards such as CDISC SDTM. Your exports are configured using the fully integrated validated mapping utility for repeatable exports. Mapping can be performed once the data collection model has been defined, and before the final data has been collected. Once data is locked your exports will be ready to run immediately. Providing efficiencies at the data export definition provides the end users with timely exports of the data. The exports can be run on a schedule, or the TrialMaster™ end users can select the exports to run on demand.
Key Features |
Key Benefits |
The TrialMaster™ Data Export Utility is fully integrated into the standard TrialMaster™ eClinical software for ASCII, SAS and CDISC SDTM exports. |
Additional tools are not required to build or run the clinical data exports. Updates to the export utility and standards are included with TrialMaster™ updates. |
Data can be exported on demand by the end user, or by scheduling a tasks to run on the server at a predetermined time and frequency. |
Scheduling data exports ensures that the system performance is not compromised, and that data is available when it is required by the user on network drives, ftp/sftp sites etc. |
Standard and custom data exports are created as part of the TrialMaster™ validated environment, and can be reused on additional studies. |
All data exports, including custom templates are validated and repeatable for data listings, SAS extracts, subject profiles, CDISC SDTM exports for submission, etc. |
Standard templates are available for all SDTM domains and can be created by default by the mapping utility, and included in the SDTM define.XML file. |
Adding the SDTM domains by default, reduces the time required for definition & validation. Early definition of the exports allows for less lag time at the end of the study. |
Data can be exported in standard ASCII, SAS and CDISC SDTM format data is available for the study, site, patient, visit, form, group, item and codelists, in addition to the clinical data, and data management information. |
Standard analyses tools can be used to import and view and import the data. Data can be displayed in Excel, or in SAS or as an SDTM export including the define.XML file. |