Source data verification (SDV) has been reported to account for up to 25% of the budget in clinical trials (CT) and cost‐benefit of SDV has been questioned. Guidelines for risk‐based… Click to show full abstract
Source data verification (SDV) has been reported to account for up to 25% of the budget in clinical trials (CT) and cost‐benefit of SDV has been questioned. Guidelines for risk‐based monitoring (RBM) were published in 2013 by agencies and in 2016, ICH‐GCP‐E6‐(R2) added a requirement for risk‐based approaches. This report will perform a comparison of the impact of RBM vs classic monitoring (CM) on data quality (defined as accuracy of data reporting from source data to final trial data) and expected impact on costs of CTs.
Keywords:
approaches data;
clinical trials;
impact monitoring;
data quality;
monitoring approaches
Journal Title: British Journal of Clinical Pharmacology
Year Published: 2022
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Journal Title: British Journal of Clinical Pharmacology
Year Published: 2022
Link to full text (if available)
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recommendations!