Score | Concept ID | Concept Name | Concept Group | Dataset | Expression |
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This website provides you with Biomedical Concepts represented in CDISC SDTM variables and values to help your mapping from raw data to SDTM. You can list, search and download Biomedical Concepts on this website.
Biomedical Concept on this website is an observation (intervention, event, or finding) represented in a combination of CDISC SDTM variable-value pairs. For example, a biomedical concept of Height(cm) is represented as below:
The Public Biomedical Concept Repository working group in CDISC Japan User Group SDTM (CJUG SDTM) creates Biomedical Concepts for therapeutic areas based on their understanding of Therapeutic Area User Guides (TAUGs) published by CDISC, and those for SDTM Findings and DS domains from SDTM Controlled Terminology. Fujitsu hosts this website on their tsClinical Metadata platform that supplies a repository and search capability.
You can either search or list Biomedical Concepts.
To search Biomedical Concepts, enter a search query (word or sentence) into the search field and click on the icon. The search retrieves Biomedical Concepts that match the given word/sentence using Natural Language Processing technology and returns with search score ranging from 50% to 100% (i.e. those below 50% are not displayed). The search query can be in either English or Japanese. If the query is in Japanese, then the query is automatically translated into English using Google Translate and used for the search.
To list Biomedical Concepts, click on the [+ List by Therapeutic Area], and select a therapeutic area or a SDTM domain.
You can download search results or listed Biomedical Concepts in the Excel (.xlsx) format by clicking the icon.
Therapeutic Area User Guides (TAUGs) are guidance documents and do not always define how an observation should be represented in SDTM variables and values. Therefore, the working group created Biomedical Concepts based on its understanding of descriptions and examples in the TAUGs.
Column Name | Explanation |
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Concept ID | ID that uniquely identifies each Biomedical Concept and matches the following naming convention; "CJUG" + 5 digit number with leading zeroes (e.g. CJUG00001) |
Concept Name | Name of an observation that briefly explains the Biomedical Concept |
Concept Group | Name of a group that groups similar Biomedical Concepts, usually named after the section label of the TAUG. |
Biomedical Concepts for Findings domains and the DS domain have been created from the latest SDTM Controlled Terminology (SDTM-CT 2021-06-25 as of September 2021).
SDTM Controlled Terminology has codelists for Test Codes. For QRS domains, submission values of those codelists are [QRSCAT] + "TC" where [QRSCAT] is a CDISC Synonym of --CAT codelist items. Biomedical Concepts for QRS domains have been created for those Test Codes, corresponding Test Names and Category.
For non-QRS Findings domains, codelists for Test Codes end with "TESTCD" or "TSCD". Biomedical Concepts have been created for those test codes, corresponding test names and optionally for --CAT, --ORRES, --ORRESU, --STRESC, --SPEC and --METHOD if they are available.
For the DS domain, Biomedical Concepts have been created for DSCAT and DSDECOD from the DSCAT, NCOMPLT, PROTMLST and OTHEVENT codelists.
Column Name | Explanation |
---|---|
Concept ID | ID that uniquely identifies each Biomedical Concept and matches the following naming convention; Findings Domains: "CT" + Submission Value of Codelist + "_" + Test Code + Sequence Number (e.g. CTVSTESTCD_HEIGHT1) DS Domain: "CTDS" + 5 digit number with leading zeroes (e.g. CTDS00001) |
Concept Name | Findings Domains: Derived from Test Name and also from other values of the Biomedical Concept if Test Name does not uniquely describe the Biomedical Concept. DS Domain: Submission Value of DSDECOD |
Concept Group | Domain Label |