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RP vs PE for Gyn Exam.
RP vs PE for Gyn Exam.
Although this is not a Pinnacle21 question (I recomment the "SDTM experts" LinkedIn formum at https://www.linkedin.com/groups/2758697), I can provide some hints:
- PE typically has PEORRES=NORMAL or when the finding is abnormal, the abnormality is described in PEORRES, e.g. PEORRES=ENLARGED
- Have a look whether RPTESTCD/RPTEST is an extensible codelist. If it is, you are allowed to add additional test codes/names. In that case, you must describe that by adding them in the corresponding define.xml CodeList with an extra attribute def:ExtendedValue=Yes.
And remember: examples are examples, nothing more than that. They cannot replace the specification.
RP vs PE
CDISC plans to release a statement with the proposal to decommission the Physical Examination domain in SDTMIG v3.3, as the PE domain is redundant with the body system-based physiology/morphology domains that CDISC has been moving to. I believe it would be acceptable to continue to use the PE domain for current submissions, however the recommendation would be to move in the direction that CDISC is moving, which is to stop using the PE domain, and instead use body-system-based domains for body-system findings, collect abnormalities on either medical history forms (baseline) or adverse events forms (post-baseline), and if needed, use the PR domain to capture an occurrence of a physical examination.
I am wondering if findings related to Gynecological Examination, Vaginal Examination, Vaginal Cell Maturation Index, Endometrial Biopsy and PAP Smear should go into the Reproductive System Findings (RP) or the Physical Examination (PE) domain. SDTMIG 3.2 does mention that the RP domain should capture all Reproductive information related to a subject but I find that these types of findings do not directly relate to “birth” as most examples provided in the SDTMIG 3.2 do. I also find that there are no Reproductive System Findings Test Name related to these findings currently available in the extensible RPTEST Controlled Terminology for the required variable RPTEST.
If I put these findings in the PE domain, I find that the Body System (PEBODSYS) with which these findings should be associated is “Reproductive System” which brings me back to the SDTMIG 3.2 claim that the RP domain should capture all Reproductive information related to a subject.