Site data entry is not a simple clerical task. GCP requires the investigator to delegate the work only to personnel who are qualified by education, training, and experience; in most studies this is a study nurse/coordinator with clinical knowledge (B, D). In addition, every person performing data entry must receive study-specific and system-specific EDC training so they can enter data correctly and respond to queries (C). Therefore these three points are key considerations when deciding who should perform site data entry.

A. Assumes data entry “requires little training,” contradicting GCP and GCDMP requirements for qualified, trained personnel; reducing burden alone is not an adequate justification.

1. Society for Clinical Data Management. Good Clinical Data Management Practices (GCDMP), “Investigator Site Data Entry,” Rev-2021, §3.2 Training Requirements, pp. 6-7.

2. ICH E6(R2) Good Clinical Practice, §4.1.1 & §4.1.5: Investigator may delegate tasks only to qualified, trained staff.

3. Johns Hopkins Medicine, Clinical Research Coordinator Training Manual (university courseware), Ch. 2 “Coordinator Qualifications,” pp. 9-11.

4. Simon, C. & Cody, M. “Defining the Role of the Clinical Research Coordinator.” Journal of Clinical Research Best Practices, 2013;9(3):1-7. doi:10.13140/RG.2.1.4140.0168.