AData Transfer Agreement (DTA)defines the operational and technical details for transferring data between a sponsor and an external vendor (e.g., central lab, ECG vendor). It is a formalized, controlled document specifyingwhat data will be sent, when transfers will occur, the transfer method, file structure, encryption or security protocols, and the recipients of the data.
The DTA is developed jointly by the sponsor and vendor before production data transfers begin. According to theGCDMP, Chapter on External Data Transfers, this agreement ensures both parties share a clear understanding of timing, responsibility, and data content to minimize errors and ensure regulatory compliance.
TheData Management Plan (DMP)outlines general data handling processes but does not capture the technical specifics of vendor data transfer logistics. TheProject Plan (A)andCommunication Plan (B)are broader operational tools and not specific to data transfer protocols.
Hence,option C (Data Transfer Agreement)is the correct answer, as it precisely governs the procedural and technical framework of vendor data exchange.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: External Data Transfers, Section 4.1 – Data Transfer Agreements and Specifications
ICH E6(R2) Good Clinical Practice, Section 5.5 – Trial Management, Data Handling, and Record Keeping
