Although clerical staff can technically perform data entry,data entry in clinical research requires study-specific training, particularly in the use of theElectronic Data Capture (EDC) systemand understandingdata discrepancy resolutionprocedures.
According to theGood Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection)andICH E6 (R2), individuals responsible for data entry at clinical sites must bequalified by education, training, and experience. This includes understanding how to navigate the EDC system, enter data according to CRF Completion Guidelines, and appropriately respond to queries or system-generated edit checks.
Untrained clerical personnel may inadvertently introduce errors, violate Good Clinical Practice (GCP) standards, or fail to recognize protocol-relevant data. Therefore, theData Managermust ensure that site users receivestudy-specific and system trainingbefore gaining access to the EDC environment.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 5.2 – Investigator Site Training and Data Entry Requirements
ICH E6 (R2) Good Clinical Practice, Section 4.1.5 – Qualified Personnel and Training Requirements
FDA 21 CFR Part 11 – User Access and Training Provisions for Electronic Records
