When a clinical study usesblood pressure (BP)as anefficacy endpoint, the most reliable and standardized method of data collection is throughstudy-provisioned equipment.
According to theGCDMP (Chapter: CRF Design and Data Collection), data collected for primary efficacy endpoints must beconsistent, accurate, and standardized across all investigative sites. Usingstudy-provided calibrated equipmentensures that measurements are taken under uniform conditions, eliminating inter-site variability due to differences in devices, calibration, or measurement methods.
Collecting BP data from medical records (option A) risks inconsistent timing and techniques. Using each site’s own equipment (option B) introduces variability, while patient self-reports (option D) lack reliability and objectivity.
Thus, thebest practiceis to provision and standardize all equipment used to collect endpoint-related physiological data, ensuring regulatory-quality results suitable for analysis.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 5.1 – Standardization of Clinical Measurements
ICH E6 (R2) GCP, Section 5.5.3 – Data Accuracy and Equipment Standardization
FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 – Data Capture and Standardization Requirements
