In the context ofdatabase design and external data management, atest data transfer(or trial data load) is performed to ensure the proper configuration, structure, and integrity of data imported from an external vendor or system. Thesecond test transferis specifically useful to confirm thatdata structures and formatsare consistently aligned between the sending and receiving systems after initial adjustments have been made from the first test.

According to theGood Clinical Data Management Practices (GCDMP), thefile format— including variables, data types, field lengths, delimiters, and encoding — must be validated during test transfers to confirm compatibility and ensure accurate loading into the target database. Once the initial test identifies and corrects errors (e.g., mismatched variable names or data types), the second transfer verifies that the corrections have been implemented correctly and that the file structure functions as intended.

Testing change management (A) involves procedural controls, not data transfers. Thetransfer method (C)andtransfer frequency (D)are validated during initial process setup, not during subsequent test transfers.

Therefore,option B (File format)is correct, as the second test transfer verifies the technical integrity of the file structure before live production transfers begin.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: External Data Transfers and Data Integration, Section 5.2 – Test Transfers and File Validation

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.3 – Data Import and Validation Controls