When electronic patient-reported outcomes (ePRO) devices are used, data are captured directly by subjects through validated devices and transmitted electronically to the study database. To ensurereal-time data quality control,programmed edit checksshould be implementedat the point of data entry— that is, as subjects input data into the device.
According toGood Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning),front-end programmed edit checksare the optimal method to prevent entry of invalid or out-of-range values in ePRO systems. This helps maintain data accuracy at the source, minimizing downstream queries and data cleaning workload.
OptionsAandBinvolve post-submission or manual review, which is less efficient and not compliant with the principle offirst-pass data validation.Option C(visualization) is a valuable secondary QC method for trends, but not for immediate data validation.
Therefore,option Dis correct —programmed edit checks upon data entryensure immediate validation and higher data integrity.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 5.3 – Automated Edit Checks and Front-End Validation
ICH E6(R2) GCP, Section 5.5.3 – Computerized System Controls and Validation
FDA Guidance for Industry: Electronic Source Data in Clinical Investigations (2013), Section 6 – Real-Time Data Quality Control
