Astandardized data collection elementhas well-defined metadata, consistent naming conventions, and controlled terminology to ensure uniform data collection and interoperability across studies.
Key attributes, as perGCDMPandCDISC standards, include:
Aclear definitionof meaning (A)
Acontrolled set of response values(C)
Metadata specificationslike variable names, formats, and data types (D)
However, thephysical positioningof a data element on a case report form (B) is a matter ofform layout design, not a characteristic of data standardization. While consistent form structure aids usability, it is not part of data standardization or metadata management principles.
Hence,option Bis correct —form positioning is not a standardized data element attribute.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Standards and Data Integration, Section 4.1 – Data Element Standardization
CDISC CDASH Implementation Guide, Section 3.2 – Standardized Data Collection Elements and Metadata
ICH E6(R2) GCP, Section 5.5.3 – Data Handling and Standardization