A Data Manager is importing data from an external facility. Which is commonly checked first?

The first and most fundamental step when importing external data is to verify that the incoming files are conformant to the pre-agreed Data Transfer Specification (DTS) or Data Transfer Agreement (DTA). This structural check ensures the file format, naming convention, column headers, data types, and overall layout are correct. If a file fails this initial validation, it cannot be processed correctly, rendering subsequent checks on its content (such as record counts or data consistency) meaningless. This step acts as a gateway for all further data validation and integration activities.

A. Incoming files have the expected number of records: This is a content validity check that occurs only after the file's structure has been successfully verified and parsed.

C. Data in incoming files are consistent with existing data in the study database: This reconciliation step happens much later in the process, after the incoming file has passed both structural and internal validation checks.

D. Data in the incoming files are internally consistent: Running internal edit checks requires the system to first successfully read and understand the file, which is only possible if it conforms to the specification.

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1. Society for Clinical Data Management. (2023). Good Clinical Data Management Practices (GCDMP). Section 7.4, "Data Transfer." This section emphasizes that a DTS must be established and that upon receipt, data files are checked for conformity to this specification as an initial step.

2. Prokscha, L. A. K. (2011). Practical Guide to Clinical Data Management. CRC Press. In Chapter 11, "Managing Laboratory Data," the process for handling external data is described as beginning with a check to ensure the received file "meets the specifications for file format and content" before it is loaded for further validation (p. 169).

3. Krishnankutty, B., Bellary, S., Kumar, N. B. R., & Moodahadu, L. S. (2012). Data management in clinical research: An overview. Indian journal of pharmacology, 44(2), 168–172. The article describes the data validation process, which logically begins with verifying the structure and format of data sources before proceeding to content-level checks. https://doi.org/10.4103/0253-7613.93842 (See section on "Data Validation").