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QSDTC mapping
Hi Olga, Even though this…
Hi Olga,
Even though this is not an oncology trial, it sounds like the Mayo score is being determined by a clinician so it is a clinical classification. Beginning in SDTMIG v3.3, both oncology disease response (e.g. RECIST) as well as clinician-determined assessments should be mapped to the RS domain.
From the SDTMIG v3.3 regarding Clinical Classifications in the RS section:
'Clinical Classifications are named measures whose output is an ordinal or categorical score that serves as a
surrogate for, or ranking of, disease status, symptoms, or other physiological or biological status. Clinical
classifications may be based solely on objective data from clinical records, or they may involve a clinical
judgment or interpretation of the directly observable signs, behaviors, or other physical manifestations related to
a condition or subject status. These physical manifestations may be findings that are typically represented in
other SDTM domains such as labs, vital signs, or clinical events.'
I would recommend that these scores/assessments be mapped to RS rather than QS in this case. In response to your question of whether the --DTC should be populated with the date of the procedure vs the assessment, I would recommend that the date of assessment be populated in RSDTC. The date of procedure is already populated in PRSTDTC. The two records in PR and RS can then be related via RELREC.
Hope this helps. Please let me know if you have further questions.
Thanks,
Kristin
QSDTC mapping
Another good answer to this question can be found on LinkedIn: https://www.linkedin.com/groups/2758697/
Hello CDISC/FDA/PMDA Experts!
I have question about date of procedure vs date of assessment. I’ve been chasing my tail and my head stopped working. I apologize if there is a clear cut SDTM IG about this and I missed it.
Date of assessment might not be same as date of procedure/sample collection.
For example, to determine the extent of inflammation in colon for patients with Ulcerative Colitis, endoscopy procedure occurred on 2022-02-20. Mayo Endo Score was determined by PI during patient’s visit. After that, endoscopy video was sent to another evaluator, somewhere around our globe (different time zone) to get a second opinion. Video is processed, second evaluator reviewed video remotely, and if score doesn't match with what local PI determined at the site during patient's visit, then adjudication will be required. After adjudication, final Mayo score is determined. It can take up to three days after the endoscopy was performed – 2022-02-23.
We mapped endoscopy date to PR.PRSDTC=2022-02-20. That’s clear.
Now to my question: for SDTM QS.QSDTC, where QSCAT=CENTRAL READ (second evaluator), for the subscore of endoscopic inflammation, do we pick date of endoscopy procedure (2022-02-20) or date of final score determination (date of central reader assessment=2022-02-23)?
Please note, I’m not using RS (Disease Response and Clin Classification) domain, because this is not oncology trial.
Any suggestions are appreciated.