1. Society for Clinical Data Management (SCDM). (2023). Good Clinical Data Management Practices (GCDMP).
Section 6.4.2, Data Review: This section describes data review activities that go beyond simple programmed checks. It states, "Data review is the process of reviewing data for errors, omissions, and inconsistencies... This review may be manual or computer-assisted." The example in option B, a cross-form consistency check requiring clinical context, is a classic example of the type of inconsistency identified during manual data review, as opposed to the simple, single-field checks described in options A, C, and D, which are covered under Section 6.4.1, Edit Check Programs.
2. 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. https://doi.org/10.4103/0253-7613.93842
Page 170, "Data validation" section: The article distinguishes between computerized checks and manual checks. It describes manual checks as a "manual review of the data for any inconsistencies, which are not covered in the computerized checks." The cross-check between adverse events and concomitant medications (Option B) is a typical example of a logical inconsistency that often requires manual review, whereas checks for valid values (A), missing data (C), and ranges (D) are standard computerized validations.
3. Lopienski, K., & Turek, P. (2017). Data Management in Large-Scale Research. Springer International Publishing.
Chapter 3, Section 3.2.2, "Validation Rules": This chapter details different types of data validation. It categorizes checks like missing values (C), value lists (A), and range checks (D) as basic, automatable validation rules. It contrasts these with more complex consistency checks that "verify logical dependencies between different data items," which often require manual review or sophisticated programming. The relationship between an AE and a ConMed (B) is a prime example of such a logical dependency.