Apologies for the late reply. The concentration data does go into the PC domain and the parameters in the PK domain.
You would pick the unit from the PK Units of Measure codelist from the SDTM Controlled Terminology list. Whether gDNA is grams of DNA or genomic DNA (assuming latter), the closed controlled term would be DNA copies/ug tissue. Since that is incorrect, you would want to submit a request to CDISC for a new preferred term at this link: Term Suggestion
You would pick "multiple" for the CDISC codelist dropdown because you would be likely requesting for both nonclinical (SEND) and clinical (SDTM). Since your PK scientist also likely needs additional terms, you can request all of the terms at the same time.
The good news is that you don't need to be a terminology expert. Make a suggestion for the term, put as much text into the description section that you want, and a CDISC terminology team will review your request. If they accept, reject, or use a different terminology preferred due to naming rules, you will be notified of their decision.
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Joleen White Ph.D.
AAPS 2024 Global Health Community Chair
Bioanalytical 101 Course Development
Senior Bioassay Development Lead
Gates Medical Research Institute
Cambridge MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 10-15-2024 20:49
From: Anonymous Member
Subject: CDISC SDTM for PK for CAR T therapies measure as vector copies/gDNA
This message was posted by a user wishing to remain anonymous
Hi Community
I am new to CDISC SDTM domains. I am wondering which domains can be used for PK that uses vector copies number/gDNA to measure cellular kinetics in CAR T cells. Would this go under PC domain?
Thank you in advance!