For clinical investigational sites on an EDC trial, which of the following archival options allows...

Regulatory agencies such as theFDAandICHrequire thatelectronic data be retained in a format that preserves audit trails and traceability.

While PDF images (option C) provide a static representation of data, they do not preserve theunderlying audit trail(i.e., who changed what, when, and why). TheASCII data files with corresponding audit trails(option D) provide complete transparency and comply with21 CFR Part 11andGCDMParchival standards.

Option A(storing computers) is unnecessary and impractical, andOption B(paper source documents) are site records, not system archives.

Hence,option Dis correct —ASCII data files with audit trailsmeet traceability and compliance standards.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Lock and Archiving, Section 5.4 – Archival Formats and Audit Trail Retention

ICH E6(R2) GCP, Section 5.5.3 – Data Integrity, Audit Trails, and Record Retention

FDA 21 CFR Part 11 – Electronic Records; Audit Trail and Retention Requirements