The scope of the metadata for the CDASHIG PE domain is limited to general physical examinations as part of overall safety-data collection. The data collection fields defined in the CDASHIG Metadata Tables may not fit the needs of targeted body system evaluations as part of therapeutic area-specific assessments.
Please refer to CDASHIG v2.1 section 8.3.11 scenario 1 best practice. This example follows the best practice recommendation to map the data to PR, rather than PE.
Package(s)
PE eCRF Package
PE eCRF Package