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ClinicalTrialOntology / CTO

CTO: Core Ontology of Clinical Trials
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change "investigational molecular entity" to "investigational substance" #38

Open linikujp opened 3 years ago

linikujp commented 3 years ago

The substance is wider than the molecular entity, for example, a Ginseng mixture under investigation is not a molecular entity, but a molecular entity aggregate. We incline to use a term "substance" instead of "molecular entity aggregate", which is defined in ISO 11238 standard by FDA, related with the GRSR (https://gsrs.ncats.nih.gov/). We need to check where the substance will be in BFO, comparing to the molecular entity aggregate. [Discussed by Asiyah Lin and Leon Li on CTO call 6/10/2021]

linikujp commented 3 years ago

Discussed on 07/07/2021 NCIt term substance : _Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical. -> this is the same definition as the ISO 11238 definition. substance vs. drug. drug is a product, and substance can be anything - chemical, additives, dietary ingredient.

However, this investigational substance does not cover investigational device. The device has part substance. The term used in Europe " investigational medicinal product" maybe a class covers both substance and device. This is for another issue.

Conclusion drawn by the group discussion: All members agree to use "investigational substance."