In its initial position paper and risk-based monitoring (RBM) update, TransCelerate introduced an important distinction between source data verification (SDV) and source data review (SDR).
SDR, according to the consortium, “is not a comparison of source data against CRF (case report form) data,” but rather, “a review of source documentation to check quality of source, review protocol compliance and ensure critical processes and source documentation are adequate.” SDV, on the other hand, is defined as “the process by which data within the CRF or other data collection systems are compared to the original source of information (and vice versa).”
While this distinction provides a welcome framework with which to guide site monitoring attention more effectively, confusion regarding the scope of SDV and SDR persists. Indeed, SDV’s primary purpose is to verify the information transcribed in the eCRF is complete and consistent with source records. However, SDV also helps to ensure eCRF and source records together meet various protocol and clinical expectations. This overlaps to some degree with TransCelerate’s definition of SDR, but the overlap is complementary.
Similarly, SDR should not completely exclude eCRF review. An example is a potential adverse event identified in a laboratory report, observed when reviewing the site’s process for timely review of labs by a physician. This SDR observation rightly would compel the site monitor to confirm whether the adverse event also had been recorded accurately in the eCRF.
So SDV and SDR should not be thought of as mutually exclusive processes but, instead, as complementary ones. It is most important to understand which activities contribute the most to ensuring overall site and data quality. A consistent understanding of each also will be key to enabling clinical teams to implement more effective RBM programs.
Written by Guest Writer Kyle Given. Given is strategic consulting services principal at Medidata, responsible for the Risk-Based Monitoring consulting practice. With over 20 years in clinical research, he is a recognized expert in operational efficiency models including RBM. Previously, he was executive vice president at Research Pharmaceutical Services (RPS), designing, implementing and enhancing global site management and monitoring organizations through processes, technologies and advanced business analytics. He also led the U.S. clinical research operational team at Sanofi. www.mdsol.com
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