In the EDC database, which factors are considered when defining user roles?

InElectronic Data Capture (EDC) systems, user roles are defined based on thefunctions and permissionsrequired for specific study tasks. The most fundamental and universally applicable roles areData Entry(performed by site staff) andData Review(performed by monitors or data managers).

According to theGCDMP (Chapter: Technology and Electronic Data Capture Systems), defining user roles involves:

Assigningfunctional access levels(e.g., entry, review, query resolution).

Ensuringrole-based securityto protect data integrity.

Complying with21 CFR Part 11andICH E6(R2)access control standards.

OptionsB,C, andDinclude functions (protocol review, analysis programming) not directly controlled within an EDC system.

Thus,option A (Data Entry and Data Review)correctly represents the two core factors considered when defining user roles.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Technology and Electronic Data Capture Systems, Section 4.3 – User Access, Roles, and Permissions

ICH E6(R2) GCP, Section 5.5.3 – System Access and Security Controls

FDA 21 CFR Part 11 – Access Control and Audit Trail Requirements