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Bringing SDTM alive for monitoring and review

CDISC Preclarus

As clinical trials require more robust and user-friendly systems to review and monitor data and conduct effective risk-based monitoring, the use of industry data standards can greatly drive efficiencies and reduce variations in data.

One example of industry data standards that has opened up a large number of beneficial opportunities in clinical trials is the increasingly wide acceptance of CDISC SDTM (Study Data Tabulation Model) standards for submission, to regulatory authorities, of the patient data we collect on our clinical trials.

SDTM standards can be leveraged to create a user-friendly, highly visual and interactive environment, in which any clinical trial team that has SDTM data can quickly access and efficiently review their patient data while the study is progressing. This includes, but is not limited to, safety review, identifying data issues, supporting dose escalation and identifying trends.

Creating a comprehensive solution in which data is presented from CDISC standards is scalable and can greatly increase efficiencies as the same processes can be deployed across many studies, as long as those studies provide their data in CDISC SDTM format. Using a solution like this also saves time, as the data environment is developed in advance of trial data being collected. It is particularly rewarding to see how quickly new studies can load their data and provide answers back to the study team.

Through a deep dive into CDISC SDTM data and studying its suitability for use in an operational setting, PPD developed the Preclarus® Patient Data Dashboard, which has been deployed on more than 70 studies. The dashboard allows study teams to efficiently monitor patient safety throughout the course of a trial, with features that include the ability to drill down to subject level data and view therapeutic area specific visualizations.

CDISC SDTM has become a standard with a much greater application than its original remit of regulatory submission. PPD’s Preclarus Patient Data Dashboard is proof of that. We bring CDISC SDTM alive for clinical trial monitoring and review, to positively impact the quality of our trials.

Philip Bartle is an associate director in clinical innovation.

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