Representing Pandemic Impacts in Clinical Trial Data and Outputs
Abstract: The COVID-19 pandemic disrupted clinical trial conduct through missed or modified visits, site and travel restrictions, changes in laboratory procedures, protocol deviations, treatment interruptions, and participant-level infection or related events. These impacts can appear across multiple collection sources and are difficult to summarize consistently when teams identify them independently. This paper describes a standards-oriented implementation framework for tracing pandemic-related information from collected data through SDTM, ADaM, and selected tables, figures, and listings (TFLs). The approach begins with a source inventory and a controlled impact taxonomy. It then links relevant records across source domains, represents visit modifications and other impacts in the appropriate standardized structures, derives subject- and event-level analysis indicators, and produces outputs from validated analysis data. Free-text classification can help locate candidate records, but requires review against the source text and related records. A focused reconciliation process is essential when operational, adverse-event, and visit data do not agree. The framework is intended as a reusable implementation aid, not as a report of study outcomes or a replacement for current CDISC and regulatory guidance. It can help programming and data standards teams improve traceability, consistency, and reviewability while preserving the distinction between pandemic-related disruption and disease-specific clinical events.
Keywords: COVID-19 Clinical Trial Disruptions, CDISC Data Standards, SDTM and ADaM Implementation, Clinical Data Traceability, Pandemic-Related Protocol Deviations
How to Cite?: Jyoti (Jo) Agarwal, Sushil Tripathi, "Representing Pandemic Impacts in Clinical Trial Data and Outputs", Volume 12 Issue 3, March 2023, International Journal of Science and Research (IJSR), Pages: 1883-1885, https://www.ijsr.net/getabstract.php?paperid=SR230329113038, DOI: https://dx.doi.org/10.21275/SR230329113038