Study JSON v4
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The current (version 4) form of the JSON schema for the Study file is shown below.
This version was created in September 2020.
{
$schema": "http://json-schema.org/draft-07/schema#",
"$id": "http://ecrin.org/json_schemas/mdrstudy/v4.json",
"title": "XDC Study definition",
"description": "ECRIN Metadata Repository for clinical research objects, Study JSON definition, version 4 September 2020",
"type": "object",
"required": ["id", "display_title"],
"additionalProperties": false,
"properties": {
"file_type": {
"type": "string",
"description": "always 'study'"
},
"id": {
"type": "integer",
"description": "Internal accession number of the study within MDR database"
},
"display_title": {
"type": "object",
"properties": {
"title": {
"type": "string",
"description": "By default the public or brief study title. If that is missing then the full scientific title, as used on the protocol document"
},
"lang_code": {
"$ref": "#/definitions/lang_code"
}
}
},
"brief_description": {
"type": "string",
"description": "Brief description, usually a few lines, of the study"
},
"bd_contains_html": {
"type": "boolean",
"default": false,
"description": "Indicates if there are embedded html tags in the description text, as an aid to display management"
},
"data_sharing_statement": {
"type": "string",
"description": "A statement from the sponsor and / or study leads about their intentions for IPD sharing"
},
"dss_contains_html": {
"type": "boolean",
"default": false,
"description": "Indicates if there are embedded html tags in the data sharing text, as an aid to display management"
},
"study_type": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the study_types enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the study_types enumeration, e.g. 'Interventional', or 'Observational'"
}
}
},
"study_status": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the study_statuses enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the study_statuses enumeration, e.g. 'Active, not recruiting', or 'Completed'"
}
}
},
"study_enrolment": {
"type": "integer",
"description": "The anticipated or actual total number of participants in the clinical study."
},
"study_gender_elig" {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the gender_eligibility_types enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the gender_eligibility_types enumeration, e.g. 'All', or 'Female'"
}
}
},
"min_age": {
"type": "integer",
"description": "The numerical value, if any, for the minimum age a potential participant must meet to be eligible for the study, plus a unit of time (e.g. Years, Days)."
},
"min_age_units": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the time_units enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the time_units enumeration, e.g. 'Months', or 'Years'"
}
}
},
"max_age": {
"type": "integer",
"description": "The numerical value, if any, for the maximum age a potential participant must meet to be eligible for the study, plus a unit of time (e.g. Years, Days)."
},
"max_age_units": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the time_units enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the time_units enumeration, e.g. 'Months', or 'Years'"
}
}
},
"study_identifiers": {
"type": "array",
"items": {
"type": "object",
"description": "A composite object that indicates the value and type of the identifier, and optionally its date and organisation of origin",
"required": ["id", "value", "type"],
"properties": {
"id": {
"type": "integer",
"description": "Study identifier record primary key, generated automatically in database"
},
"identifier_value": {
"type": "string",
"description": "The identifier value, in a standardised format (for each identifier type)"
},
"identifier_type": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the identifier_types enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the identifier_types enumeration, e.g. 'Trial Registry ID', or 'Sponsor ID'"
}
}
},
"identifier_date": {
"type": "string",
"description": "The date the identifier was allocated, if known, in a string 'yyyy MMM dd' format, e.g. '2015 Dec 12'"
},
"identifier_link": {
"type": "string",
"description": "URL associated with the identifier"
},
"identifier_org": {
"$ref": "#/definitions/organisation"
}
}
}
},
"study_titles": {
"type": "array",
"items": {
"type": "object",
"description": "A composite object that indicates the type and value of any study title",
"required": ["id", "title_type", "title_text"],
"properties": {
"id": {
"type": "integer",
"description": "study title record primary key, generated automatically in database"
},
"title_type": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the title_types enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the title_types enumeration, e.g. 'Abbreviation or Acronym', or 'Translated Title'"
}
}
},
"title_text": {
"type": "string"
},
"lang_code": {
"$ref": "#/definitions/lang_code"
},
"contains_html": {
"type": "boolean"
"description": "Whether the title text has any embedded html tags, e.g. for super or subscripts"
},
"comments": {
"type": "string"
}
}
}
},
"study_features": {
"type": "array",
"items": {
"type": "object",
"description": "A composite object that indicates the type and value of any study feature - usually a design feature, often used for filtering",
"required": ["id"],
"properties": {
"id": {
"type": "integer",
"description": "Study feature record primary key, generated automatically in database"
},
"feature_type": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the study_feature_types enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the study_feature_types enumeration, e.g. 'Phase', or 'Masking'"
}
}
},
"feature_value": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the study_feature_categories enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the study_feature_categories enumeration, e.g. 'Phase 3', or 'Double'"
}
}
},
}
}
},
"study_topics": {
"type": "array",
"items": {
"type": "object",
"description": "A composite object that indicates the topic name or keyword, and - if applicable - how it was classified in the source data, the controlled terminology system used, and the code for the topic in that system",
"required": ["id", "value"],
"properties": {
"id": {
"type": "integer",
"description": "Study topic record primary key, generated automatically in database"
},
"topic_value": {
"type": "string",
"description": "The topic or keyword value or name, as provided in the source data"
},
"topic_source_type": {
"type": "object",
"description": "How the topic was categorised in the source data, (or by using the controlled terminology, or using a category matching service)",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the topic_source_types enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the topic_source_types enumeration, e.g. 'Condition', or 'Organism'"
}
}
},
"topic_ct": {
"type": "object",
"description": "If applicable, the controlled terminology system from which the topic name was taken",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the topic_controlled_terminologies enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the topic_controlled_terminologies enumeration, e.g. 'MESH', or 'Cochrane PICO terminology'"
}
}
},
"topic_ct_code": {
"type": "string",
"description": "The code for the topic within the designated controlled terminology scheme"
}
}
}
},
"related_studies": {
"type": "array",
"items": {
"type": "object",
"description": "A composite object that indicates any related study and the nature of the relationship",
"required": ["id", "relationship_type", "target_study_id"],
"properties": {
"id": {
"type": "integer",
"description": "Study relationships record primary key, generated automatically in database"
},
"relationship_type": {
"type": "object",
"properties": {
"id": {
"type": "integer",
"description": "An integer referencing the relevant record in the study_relationship_types enumeration / lookup table"
},
"name": {
"type": "string",
"description": "One of the allowed types, from the study_relationship_types enumeration, e.g. 'Is a sub-study of', or 'has an expanded access version'"
}
}
},
"target_id": {
"type": "integer",
"description": "The id, i.e. internal accession number, of the related study"
}
}
}
},
"linked_data_objects": {
"type": "array",
"items": {
"type": "integer",
"description": "The id, i.e. internal accession number, of the linked data object"
}
},
"provenance_data": {
"type": "string",
"description": "A listing of the source or sources (usually a trial registry) from which the data for the study has been drawn, and the date-time(s) when the data was last downloaded"
},
},
"definitions": {
"lang_code": {
"type": "string",
"minLength": 2,
"maxLength": 2,
"description": "A two letter ISO 369-1 code indicating the language of the study",
"default": "en"
},
"organisation": {
"type": "object",
"required": ["name"],
"properties": {
"id": {
"type": "integer",
"description": "The id of the organisation within the ECRIN contextual database, if that id exists"
},
"name": {
"type": "array",
"description": "Either the name of the organisation as supplied by the source data, or the names (may be multiple) of the organisation within the ECRIN contextual database",
"minItems": 1,
"items": {
"type": "string"
}
}
}
}
}
}
