JSON Schema for Studies
Jump to navigation
Jump to search
The current (version 5) form 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"
}
}
}
