In studies where themedical record serves as the source document, theElectronic Data Capture (EDC)system users (typically study coordinators or site personnel) must have appropriatetraining on how to access and log into the medical record system. This competency ensures that data abstracted from the electronic medical record (EMR) are complete, accurate, and verifiable in compliance with Good Clinical Practice (GCP) andGood Clinical Data Management Practices (GCDMP).

According to theGCDMP (Chapter: EDC Systems and Data Capture)andICH E6(R2), all personnel involved in data entry and verification must be trained in both the EDC and the primary source systems (e.g., EMR). This ensures that the integrity of data flow—from source to EDC—is maintained, and that personnel understand system access controls, audit trails, and proper documentation of source verification.

Whileresolving discrepant data (C)andscreening subjects (A)are part of study operations, thecompetency directly related to EDC system use in EMR-based studiesis the ability to properly log into and navigate the medical records system to extract source data.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Electronic Data Capture (EDC), Section 5.1 – Source Data and System Access Requirements

ICH E6(R2) Good Clinical Practice, Section 4.9 – Source Documents and Data Handling

FDA Guidance: Use of Electronic Health Record Data in Clinical Investigations, Section 3 – Investigator Responsibilities