Which competency is necessary for EDC system use in a study using the medical record as the source?

When using an Electronic Data Capture (EDC) system with the medical record as the source, the primary task for site personnel is transcribing data from the source to the EDC. If the medical record is electronic (EMR/EHR), which is common, staff must first be able to access it. This requires specific training on the medical records system to ensure they can log in, navigate, and locate the correct data while adhering to institutional security and privacy policies (e.g., HIPAA). This competency is a fundamental prerequisite for performing the data entry task itself. Without the ability to access the source, no data can be entered into the EDC.

A. Screening study subjects is a clinical procedure that occurs before data entry and is not a competency related to the use of the EDC system.

B. Using ePRO (electronic Patient-Reported Outcome) devices is a separate data collection method; the question specifies the medical record as the source.

C. Resolving discrepant data is a standard data management activity in any study using EDC, not a competency uniquely necessary because the source is a medical record.

1. Society for Clinical Data Management. (2023). Good Clinical Data Management Practices (GCDMP). Section 4.3.2, "Training," specifies that site personnel must be trained on all electronic systems used in the conduct of a clinical trial. This includes both the EDC system and any electronic source data systems, such as an EMR/EHR.

2. U.S. Food and Drug Administration. (2018). Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry. Section IV.A, "Ensuring the Quality, Reliability, and Integrity of EHR Data," states that sponsors should ensure sites have "procedures to ensure that only authorized individuals can access, create, or modify EHRs," which necessitates training on system access.

3. Løvestam, E., et al. (2017). Sourcing clinical trial data from electronic health records: a qualitative study of the process and its implications. BMC Medical Informatics and Decision Making, 17(1), 14. https://doi.org/10.1186/s12911-017-0413-y. The study highlights that a key challenge is the "need for training and support for the research nurses in how to find the data in the EHR," confirming that system access and navigation is a critical competency.