Assuming the data transfer, integration, and validation processes are properly controlled and compliant,electronic acquisitionof clinical data from medical devices is preferred because it allowsmore frequent and accurate data collection, leading to higher data resolution and integrity.
Per theGCDMP (Chapter: Technology and Data Integration), automated data collection minimizes manual transcription and reduces latency in data capture, ensuring both efficiency and completeness. While manual processes introduce human transcription errors and limit frequency, continuous electronic data capture can record thousands of accurate, time-stamped measurements, improving the study’s analytical power.
However,option Dslightly overstates the case — human error isreduced, not entirely eliminated, since setup, calibration, and integration still involve human oversight. Therefore,option Cis the best and most precise response, emphasizing the advantage of more robust and complete data capture.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Technology and Data Integration, Section 5.4 – Automated Data Acquisition and Validation
ICH E6(R2) GCP, Section 5.5.3 – Validation of Computerized Systems and Electronic Data Sources
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.3 – Direct Data Capture from Instruments and Devices
