A Data Manager is importing lab data for a study. The lab data and the associated audit trail is kept at the central lab. What is necessary to…

Maintaining an unaltered copy of the data as it was received from the central lab is the foundational step for ensuring traceability. This "as-received" file serves as the authoritative source against which all subsequent actions—such as loading, transformations, and cleaning—can be compared and verified. This practice creates a clear and auditable trail from the point of data receipt, which is essential for data integrity and regulatory compliance, as the original audit trail resides with the data provider.

A. Making changes only after data have been imported: This describes the timing of an action but does not, by itself, create a traceable record of what the data looked like before the changes were made.

C. Making changes only for exceptions: This is a data cleaning or validation rule, not a mechanism for ensuring traceability of the data's history.

D. Making changes only on the copy of the received data: While this is a correct procedure, it is incomplete. The core principle of traceability relies on first preserving the original file (Option B) to serve as a baseline for comparison.

1. Society for Clinical Data Management (SCDM). (2018). Good Clinical Data Management Practices (GCDMP), Version 2.0.

Section 6.5, External Data: This section explicitly states, "The original electronic file as received from the external data provider should be retained, unaltered, in a secure location. All data handling steps (e.g., loading, transformations, cleaning) should be documented to provide a clear audit trail from the point of receipt to the final database." This directly supports retaining an original copy for traceability.

2. Prokscha, S. (2011). Practical Guide to Clinical Data Management (3rd ed.). CRC Press.

Chapter 11, External Data Handling, Section 11.4, Data Transfer: This chapter emphasizes the importance of archiving the original data files received from external vendors. It notes that "The original data file as received from the vendor must be archived in its original format... This is the source document for the loaded data and must be available for quality control checks and audits."

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.

DOI: https://doi.org/10.4103/0253-7613.93842

Page 170, Section: Data Processing: The article discusses the need for a complete audit trail for all data handling procedures. It states, "All data handling procedures must be documented... to allow a step-by-step retrospective assessment of the data quality and study performance." Retaining the original transferred file is the first step in this documentation process.