The Clinical Data Interchange Standards Consortium (CDISC) created standards designed to streamline clinical research data and essentially enable reviewers to more fully assess the efficacy and safety of a product. In 2014, the FDA mandated that study data be submitted in conformance with CDISC standards. While research organizations are evolving this data from their electronic data capture (EDC) databases and reporting systems to CDISC standards before submitting the results to the agency, many are doing so after the completion of the clinical trial—with some companies even waiting until the confirmation that their study will be submitted.
However, by integrating CDISC standards at the beginning of the clinical trial, researchers can put their data to work quickly by using the interactive data analytics embedded within the CDISC standards to generate reports for risk-based monitoring, data quality and fraud detection, program validation, and more—as soon as the study begins. Here are four key benefits of integrating CDISC standards from the get-go.
1. Detecting Site Problems Quickly
Data collected in an EDC system can be periodically exported and automatically migrated to CDISC standards. This strategy allows the analytics to go to work immediately, providing insight into any unusual areas or flaws, such as a site where patient report outcomes aren’t in line with other sites. As such, researchers are able to address problems immediately.
2. Detecting Unusual Data
The data analytics reports can facilitate risk-based monitoring by tagging the sites where the reporting data is questionable or outside of the norm. Like the ability to identify site flaws, finding data problems early leads to a quick resolution.
3. Increasing Safety Monitoring
Standardization of the data provides streamlined safety analysis reports for safety and pharmacovigilance teams, sponsors, and project managers. For example, in the case of a reported serious adverse event (SAE), the incident falls under the category of defined regulatory guidance. This standardization enables the team to immediately evaluate the severity of the information, determine possible causality related to the product, and process related reports. Further, standardization enables the safety team to develop a profile related to the product in the study.
Standardization also helps to streamline the data by weeding out unnecessary data and false assumptions, ensuring regulatory timelines are met, as well as enabling early review and analysis. These advantages lead to lower costs for sponsors and boost efficiencies for regulatory reviewers.
4. Reducing Incidences of Fraud
The data analytics capabilities within the CDISC standards can immediately identify incidences of fraud, eliminating them from the equation before the integrity of the clinical trial is irreversibly compromised.
From general study progress reports to on-demand analysis reports for demographics, findings, events, and more, leveraging the power of these analytics tools within the CDISC standards enables faster reporting, faster submission-ready data, and higher quality output.
For more on this topic, download the full report, “Putting CDISC Standards to Work.”
