Data & Quality
Source Data Verification (SDV)
Source Data Verification (SDV) is the process of comparing data entered into the case report form against the original source documents (medical records, lab reports, imaging) to confirm that the recorded data are accurate, complete, and verifiable.
Historically, sponsors performed 100% SDV at every monitoring visit. ICH E6(R3) and FDA's Risk-Based Monitoring guidance endorse targeted SDV; verifying critical data fields and high-risk patients only, supplemented by centralized statistical monitoring.
Targeted SDV reduces monitoring costs by 30; 50% without measurable loss of data quality, per TransCelerate's RBM evidence base.
Related terms
Clinical Trial Monitoring
Clinical trial monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Case Report Form (CRF)
A Case Report Form (CRF) is the printed, optical, or electronic document designed to record all protocol-required information about each clinical trial participant, supporting regulatory submission and statistical analysis.
Good Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
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