Inpaper-based trials, site staff (e.g., study coordinators) record data manually on paper Case Report Forms (CRFs), which are later transcribed by data entry personnel into an electronic database.
However, inEDC-based studies, thesite coordinatoris directly responsible forentering data into the EDC system. This eliminates the need for centralized double data entry and shortens data cleaning timelines.
TheGCDMP (Chapter: Electronic Data Capture Systems)states that EDC systems shift certain tasks, includingdata entry, initial query response, and source verification preparation, to the site level. Yet,data entryremains the most significant additional responsibility compared to paper-based studies.
Option A (Query resolution)is performed in both EDC and paper-based systems.
Option C (Data curation)is typically a Data Management function.
Option D (Medical record abstraction)is part of source documentation, not specific to EDC.
Thus,option B (Data entry)is correct — it is the additional site coordinator duty unique to EDC environments.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.3 – Site Responsibilities and Workflow Changes
ICH E6(R2) GCP, Section 5.5.3 – Data Entry and Role Delegation in Computerized Systems
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.2 – Site-Level Data Entry Controls
