In Electronic Data Capture (EDC) studies, proper user training and access management are essential for maintaining data integrity, security, and regulatory compliance. According to the Good Clinical Data Management Practices (GCDMP) and FDA 21 CFR Part 11, EDC systems must ensure that only qualified and trained personnel can access study data, and that all access rights reflect current study responsibilities.
User training and access must therefore be reviewed and updated whenever:
Site staff leave the study (access revocation is required),
New site staff are added (training and credentialing are required), and Study team members change roles (access levels must be modified accordingly).
However, if a software upgrade occurs that does not impact the functional roles, user permissions, or data handling processes, retraining or reauthorization is not required. This is because such updates do not alter compliance-critical workflows or user interactions.
Therefore, the exception is C - when a software upgrade does not affect users.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture Systems, Section 7.1 - User Access and Training Controls FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures, Section 11.10(i) & (k) ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - System Security and User Training