Study JSON v5
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Version 5 of the JSON schema for the Study file is shown below.
This version was created in October 2020.
{
"$schema": "http://json-schema.org/draft-07/schema#",
"$id": "http://ecrin.org/json_schemas/mdrstudy/v5.json",
"title": "XDC Study definition",
"description": "ECRIN Metadata Repository for clinical research objects, Study JSON definition, version 5 October 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 the MDR database"
},
"display_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"
},
"brief_description": {
"type": "object",
"description": "Brief description, usually a few lines, of the study",
"properties": {
"text": {
"type": "string",
"description": "Text of the description. For some sources may need to be derived from key study features"
},
"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": "object",
"description": "A statement from the sponsor and / or study leads about their intentions for IPD sharing",
"properties": {
"text": {
"type": "string",
"description": "Text of the statement (may be structured in some sources)"
},
"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",
"description": "Categorisation of study type, e.g. 'Interventional', or 'Observational'",
"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 types listed in the study_types enumeration"
}
}
},
"study_status": {
"type": "object",
"description": "Categorisation of study status, e.g. 'Active, not recruiting', or 'Completed'",
"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 statuses listed in the study_statuses enumeration"
}
}
},
"study_enrolment": {
"type": "integer",
"description": "The anticipated or actual total number of participants in the clinical study."
},
"study_gender_elig": {
"type": "object",
"description": "Whether the study is open to all genders, or just male or female",
"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 types from the gender_eligibility_types enumeration"
}
}
},
"min_age": {
"type": "object",
"description": "The minimum age, if any, for a study participant",
"properties": {
"value": {
"type": "integer",
"description": "The numerical value of the age"
},
"unit_id": {
"type": "integer",
"description": "An integer referencing the relevant record in the time_units enumeration / lookup table"
},
"unit_name": {
"type": "string",
"description": "One of the allowed types, from the time_units enumeration, e.g. 'Months', or 'Years'"
}
}
},
"max_age": {
"type": "object",
"description": "The maximum age, if any, for a study participant",
"properties": {
"value": {
"type": "integer",
"description": "The numerical value of the age"
},
"unit_id": {
"type": "integer",
"description": "An integer referencing the relevant record in the time_units enumeration / lookup table"
},
"unit_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",
"description": "The category of the identifier, e.g. 'Trial Registry ID', or 'Sponsor ID'",
"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 types in the identifier_types enumeration."
}
}
},
"identifier_org": {
"type": "object",
"description": "The organisation providing the identifier",
"properties": {
"id": {
"type": "integer",
"description": "The id of the organisation within the ECRIN context database, if that id exists"
},
"name": {
"type": "string",
"description": "The default name of the organisation within the ECRIN context database, if it exists, or the name of the organisation as supplied by the source data"
}
}
},
"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": "Any URL associated with the identifier"
}
}
}
},
"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",
"description": "Type of the title, e.g. 'Abbreviation or Acronym', or 'Translated Title'",
"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 types listed in the title_types enumeration"
}
}
},
"title_text": {
"type": "string",
"description": "The text of the title, verbatim"
},
"lang_code": {
"type": "string",
"description": "A two letter ISO 369-1 code indicating the language of the title"
},
"comments": {
"type": "string",
"description": "Any additional comments regaring the souce or derivation of the title"
}
}
}
},
"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",
"description": "The type of study feature, e.g. 'Phase', or 'Masking'",
"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 features listed in the study_feature_types enumeration"
}
}
},
"feature_value": {
"type": "object",
"description": "The value of the feature, as taken from a pre-defined list, e.g. 'Phase 3', or 'Double'",
"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 values listed in the relevant part of the study_feature_categories enumeration"
}
}
}
}
}
},
"study_topics": {
"type": "array",
"items": {
"type": "object",
"description": "A composite object that indicates the topic name or keyword, and - where available - the MESH coding for that term",
"required": ["id", "value"],
"properties": {
"id": {
"type": "integer",
"description": "Study topic record primary key, generated automatically in database"
},
"topic_type": {
"type": "object",
"description": "How the topic was categorised in the source data, e.g. 'Condition', or 'Organism'",
"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 listed in the topic_source_types enumeration"
}
}
},
"mesh_coded": {
"type": "boolean",
"description": "Whether or not the topic has been MESH coded"
},
"topic_code": {
"type": "string",
"description": "The MESH code for the topic if one exists"
},
"topic_value": {
"type": "string",
"description": "The topic or keyword value or name, as a MESH term if coded, otherwise as provided in the source data"
},
"topic_qualcode": {
"type": "string",
"description": "Any MESH qualifier code, if one has been applied"
},
"topic_qualvalue": {
"type": "string",
"description": "Any MESH qualifier term, if one has been applied"
},
"original_value": {
"type": "string",
"description": "The original value of the term, whether coded or not"
}
}
}
},
"study_relationships": {
"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",
"description": "The nature of the relationship, e.g. 'Is a sub-study of', or 'has an expanded access version",
"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"
}
}
},
"target_study_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_string": {
"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"
}
}
}
