How should I represent whether a physical exam was performed in SDTM?

The CDASHIG section "PE - Physical Examination" describes a best practice for collecting physical examination data. Basically, any abnormalities would be recorded as medical history or adverse events, depending on timing whether an exam was performed would be recorded by treating the exam as a procedure. The example CRF is clearly annotated and shows that the performance of the physical exam would be recorded in a field annotated as PROCCUR where PRTRT = "PHYSICAL EXAMINATION".

SDTMIG v3.4 describes this CDASH best practice and includes the statement "When following this approach, the PE domain is not used in SDTM."

Users implementing earlier versions of the SDTMIG who are dealing with data collected according to the CDASH best practice for physical examinations may not be familiar with the CDASHIG. Some users have tried to represent whether a physical examination was performed in the PE domain rather than the PR domain, in a record with PETESTCD = "PEALL" and PEORRES = "PERFORMED" or "NOT PERFORMED". This is not the way the PE domain is intended to be used; PEORRES was to be populated with the name of an abnormality or with "NORMAL". If the CDASH best practice for physical examination is followed, there should be no SDTM PE dataset; whether a physical examination was performed should be represented in the PR domain as follows:

Example 1

In the study in this example, physical examinations were scheduled at visit numbered "1" and "2". The example shows data on whether a physical examination was performed on a particular subject at each of the two visits.

Row 1: A physical examination was performed at VISITNUM "1".

Row 2: A physical examination was not performed at VISITNUM "2". This study did not record reasons why physical examinations were not performed. If such reasons were collected, they would be represented in PRREASOC, Reason for Occur Value.