The data captured in a data management system, whether via Electronic Data Capture 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 the domains required for data analysis and reporting.
The TrialMaster Custom 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 is defined and before the final data is collected. Once data is locked, your exports are 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 by the system, or the TrialMaster end users can select the exports to run on demand.
The TrialMaster Custom Data Export Utility is fully integrated into the standard TrialMaster Suite of eClinical software for ASCII, SAS and CDISC SDTM exports.
Data can be exported on demand by the end user or by scheduling tasks to run on the server at a predetermined time and frequency.
Standard and custom data exports are created as part of TrialMaster's validated environment and can be reused on additional studies.
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.
Data can be exported in standard ASCII and SAS. 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.
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.
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.
All data exports, including custom templates, are validated and repeatable for data listings, SAS extracts, subject profiles, CDISC SDTM exports for submission, etc.
Adding the SDTM domains by default, reduces the time required for definition and validation. Early definition of the exports allows for less lag time at the end of the study.
Standard analyses tools can be used to import and view the data. Data can be displayed in Excel, or in SAS or as an SDTM export including the define.XML file.