Structured, unstructured, semi-structured data. Where do CDISC publications fall?

Mainstream definition for unstructured data is data that do not contain descriptive information about the data themselves. An email body is unstructured. A newspaper op-ed is unstructured; definition further goes to describe structured data to have a rigid schema requirement. Semi-structured data are the middle category, where meaning of data is, for example, self-explanatory using markup tags.

Below are examples to illustrate these three kinds of data.

{
    "$id": "http://example.com/example.json",
    "type": "object",
    "title": "The Root Schema",
    "description": "My root schema.",
    "required": [
        "animals"
    ],
    "properties": {
        "animals": {
            "$id": "#/properties/animals",
            "type": "array",
            "title": "The Animals Schema",
            "description": "Pet animals data.",
            "default": [],
            "items": {
                "$id": "#/properties/animals/items",
                "type": "object",
                "title": "The Items Schema",
                "description": "One record per pet animal",
                "default": {},
                "required": [
                    "name",
                    "species",
                    "birthdate",
                    "dateFormat",
                ],
                "properties": {
                    "name": {
                        "$id": "#/properties/animals/items/properties/name",
                        "type": "string",
                        "title": "The Name Schema",
                        "description": "Pet animal's given name"
                    },
                    "species": {
                        "$id": "#/properties/animals/items/properties/species",
                        "type": "string",
                        "enum": [
                            "canine",
                            "feline"
                        ]
                        "title": "The Species Schema",
                        "description": "Pet animal's species"
                    },
                    "birthdate": {
                        "$id": "#/properties/animals/items/properties/birthdate",
                        "type": "string",
                        "title": "The Birthdate Schema",
                        "description": "Pet animal's date of birth"
                    },
                    "dateFormat": {
                        "$id": "#/properties/animals/items/properties/dateFormat",
                        "type": "string",
                        "title": "The Dateformat Schema",
                        "description": "Date format used in birth date",
                        "default": "dd/mm/yyyy"
                    }
                }
            }
        }
    }
}

{
    "animals": [
        {
            "name": "Taylor",
            "species": "canine",
            "birthdate": "3/12/2008",
            "dateFormat": "mm/dd/yyyy"
        },
        {
            "name": "Carter",
            "species": "feline",
            "birthdate": "12/12/2018"
        }
    ]
}

Only with the structured data example would you realize Taylor is about a dog and a cat for Carter. The schema serves an important function: gives context and rules to the data. This schema also contains information about defaults, optionality, and valid values. Because of the schema, machine would be able to process the pet animal data much more efficiently. Predictability is key.

I would like to continue with setting aside the classification of normative versus informative content in a CDISC publication. Two reasons. Firstly, no publications have them clearly delineated. More importantly, the degree of structuredness does not make content any more or less normative.

Controlled Terminology, on the other hand, has publication in PDF format rendered directly from raw data. The raw data is highly structured. NCI EVS maintains all codelist and terms in Protégé, an ontology tool. EVS extends Protégé with OWL, a web semantic layer.[1] Data serialization happens at each quarterly publication to produce formats available for download, such as CSV, Excel spreadsheet, and PDF. This structured data approach enables many scenarios of reusability. Define-XML, codelists & terms in implementation guides, and CDISC 360's biomedical concepts, just to name a few. Controlled Terminology reaps the benefit of repeatability by virtue of its highly structured nature. CDISC publishes Controlled Terminology four times per year, with a maximum of six packages each time. With this level of frequency and quantity, a repeatable process is a must.

Technology plays a significant role when working with various structuredness of data. An overall data architecture is a strategy that must be very well articulated. This impacts storage, analytics, accessibility, and discoverability. Computing evolves at rapid pace. Especially with cloud computing, it has created many choices in the marketplace for different kinds of data: RDBMS, graph database, document store, multi-model database. Long gone is the era where all data would go in to one single enterprise data store. Database-as-a-service has become a hot commodity, offering unprecedented flexibility, scalability, and modularity. Implementers today can choose to put their data in a right container for the right purpose.

In conclusion, today's CDISC products mostly fall into the semi-structured and unstructured categories. Data strategy with stakeholders about accessibility and usability should heavily influence the degree of structuredness in the kinds of data being managed, especially with novel contents. Decision makers need to factor in the strengths and weaknesses of each technology offering. Trade-offs may be inevitable, e.g., sacrifice end-to-end interoperability for a simplified data store? Prefer repeatability over schema flexibility? Immediate access or deferred availability? None of these questions have one answer for all the varying degrees of data structuredness.

[1] NCI Thesaurus Downloads: https://evs.nci.nih.gov/evs-download/thesaurus-downloads