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Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials.
Nicole Sheetz1, Brett Wilson2, Joanne Benedict3
11 Clinical Development Innovation, Eli Lilly and Company, Indianapolis, IN, USA.
Therapeutic Innovation & Regulatory Science
|September 20, 2018
Summary
Risk-based monitoring enhances clinical trial quality and safety by focusing on critical study aspects, moving beyond traditional source data verification (SDV). This approach proves more effective than generalized SDV.
Area of Science:
- Clinical trial operations
- Drug development quality assurance
- Regulatory compliance in research
Background:
- Traditional clinical trial monitoring heavily relies on source data verification (SDV).
- Emerging evidence suggests risk-based monitoring (RBM) may yield superior outcomes.
- TransCelerate BioPharma Inc. developed a novel RBM methodology.
Purpose of the Study:
- To assess the value of source data verification (SDV) in clinical trial monitoring.
- To evaluate the effectiveness of TransCelerate's risk-based monitoring (RBM) approach.
- To compare RBM strategies against conventional SDV-driven models.
Main Methods:
- Literature review on SDV's role in clinical trial monitoring.
- Retrospective analysis of data from multiple clinical trials.
- Assessment of internal audit findings from TransCelerate member companies.
Main Results:
- Generalized SDV demonstrates limited value as a primary quality control measure.
- Risk-based monitoring activities provide significant value in ensuring data quality and subject safety.
- RBM, incorporating risk assessment and adaptive monitoring, is more effective than SDV-centric models.
Conclusions:
- The study supports the hypothesis that generalized SDV has limited value.
- Risk-based monitoring activities are more effective in ensuring clinical trial quality and subject safety.
- Transitioning from SDV to RBM is recommended for improved clinical trial oversight.
Keywords:
data integrityquality controlrisk-based monitoringsource data reviewsource data verificationMore Related Videos
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