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.
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