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The Clinical Data Interchange Standards Consortium (CDISC) and electronic data capture (EDC) are two acronyms that hardly need an introduction. EDC is a widely accepted alternative for paper trials, and has numerous advantages such as immediate access to both trial data and trial status reports via the web, improved data quality by auto-queries that are fired by the EDC system as soon as data is entered, full control over the time point that trial changes are activated within an adaptive trial design, and so on. CDISC provides a set of standards that support the acquisition, exchange, submission and archive of clinical research data and metadata. Submission Data Tabulation Model (SDTM), Analysis Data Model (ADaM) and define.xml are the CDISC models that are used when creating submission packages for the FDA.
CDISC AND EDC: SHAKING HANDS
Both CDISC and EDC have offered process efficiency to the industry with the goal of reducing time to market and limiting the cost of new drugs. The EDC vendors have contributed to this efficient process by bringing in the tools that make the complete clinical trial more transparent to all of the parties involved. Increased data visibility not only allows faster query resolution, but also enables project managers to respond quickly to any trend in the trial (such as inaccurate completion of case report form (CRF) pages) which, in the end, leads to a faster database lock. CDISC has contributed to trial efficiency by offering a number of standards that are all vendor-neutral and platform-independent. These standards allow the FDA to run their review-tools on the submitted data, leading to far fewer questions about the data structure and therefore shorter review cycles with faster approval. In addition, data standards simplify the transfer between providers (Lab, ECG, IVRS) and receivers (data management and statistics teams), while the trial is ongoing. |
