SCDM CCDM Exam - Topic 5 Question 15 Discussion

Maintaining traceability of external data imports (such as laboratory results) is a fundamental principle of clinical data management. According to the GCDMP (Chapter: External Data Transfers and Integration), Data Managers must retain an unaltered copy of the raw data exactly as received from the vendor.

This archived version serves as a reference for:

Data provenance verification,

Audit trail review, and

Discrepancy resolution between vendor and study database.

Since the central lab maintains its own audit trail, the Data Manager's responsibility is to preserve the original data transmission file before applying transformations, merges, or validations.

Options A, C, and D describe procedural safeguards but do not meet the regulatory requirement of traceable data lineage. Only option B (Maintaining a copy of the data as received) ensures compliance with ICH E6(R2) and FDA 21 CFR Part 11 standards for data traceability and integrity.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: External Data Transfers and Integration, Section 5.2 -- Data Traceability and Version Control

ICH E6(R2) GCP, Section 5.5.3 -- Data Integrity and Source Data Verification

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 -- Source Data Traceability and Archiving