Clinical trial sponsors in the pharmaceutical and biotechnology industries planning to send study data to the U. S. Food and Drug Administration (FDA) during their drug development programs, must prepare and submit their datasets in FDA-supported formats.
The FDA Data Standards Catalog requires the implementation of CDISC standards, namely SDTM, SEND, ADaM and Define-XML, in addition to Controlled Terminology.
CDISC standards specify a predefined manner to collect, process, and submit clinical trial data. These standards help sponsors tabulate and manage study data in a consistent way, avoiding undesired variability. At the same time, with CDSIC the FDA can receive and review submissions more efficiently.
Specifically, SDTM (Study Data Tabulation Model) is one of the required standards for data submission of study information to the FDA.
By using OmniComm’s TrialMaster® Electronic Data Capture (EDC) solution, Sofpromed CRO provides streamlined SDTM data preparation for FDA submissions.
The clinical data collected in the TrialMaster EDC, once cleaned and verified, will be automatically exported to datasets for statistical analysis, and subsequent regulatory submission.
The TrialMaster software has a powerful Custom Data Export Utility; a drag-and-drop tool allowing the definition of export data domains, in order to map data to CDISC SDTM.
The clinical data exports are arranged using the integrated mapping tool for repeatable exports. Mapping can be done once the data collection model has been defined.
Once data entry has ended at sites and the clinical database has been locked, the exports are ready to run right away.
The exports can be performed on a predefined schedule by the system, or data managers can select the exports to be executed when needed.
In the following lines the main TrialMaster’s export capabilities and advantages are described in more detail.
TrialMaster’s Custom Data Export Utility
The TrialMaster Custom Data Export Utility is fully incorporated into the TrialMaster Suite for American Standard Code for Information Interchange (ASCII), SAS and CDISC SDTM data exports. Data managers do not need additional elements to design or run the clinical data transfers.
On Demand or Scheduled Data Exports
The study data can be exported on demand by data managers or by scheduling tasks to run at prescheduled frequencies. Planning data exports in advance ensures that the system performance is not compromised and that data is timely available when required.
Clinical Data Export Reusability
Data exports are easily created as part of TrialMaster’s validated environment and can be reused in other clinical trials. All data exports, including custom templates, can be reproduced for data listings, SAS extracts, patient profiles, or CDISC SDTM exports for submission to the FDA.
Standard Templates for CDISC SDTM Domains
Standard templates are available for all CDISC 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 and validation. The early definition of the export structures (before the study begins) avoids delays in the interim and final analyses.
Data Displayed in Excel, SAS, or SDTM
The study data can be exported in standard ASCII and SAS. CDISC SDTM format data can be obtained for the trial, hospital, subject, visit, form, and codelists. Standard analyses tools can be used to import and view the data. Data can be made available in Excel, or in SAS or as an SDTM export including the define.XML file.
For additional information about SDTM and data submissions to the FDA, please contact us at +34 607 939 266 or firstname.lastname@example.org.