Difference between revisions of "Study JSON v4"
Jump to navigation
Jump to search
(Created page with "The current (version 4) form of the JSON schema for the Study file is shown below. <br> This version was created in March 2020. <br><br> <div style="font-family: monospace;...") |
|||
| (6 intermediate revisions by the same user not shown) | |||
| Line 1: | Line 1: | ||
The current (version 4) form of the JSON schema for the Study file is shown below. | The current (version 4) form of the JSON schema for the Study file is shown below. | ||
<br> | <br> | ||
| − | This version was created in | + | This version was created in September 2020. |
<br><br> | <br><br> | ||
<div style="font-family: monospace; font-size: 13px" > | <div style="font-family: monospace; font-size: 13px" > | ||
| Line 7: | Line 7: | ||
{ | { | ||
$schema": "http://json-schema.org/draft-07/schema#", | $schema": "http://json-schema.org/draft-07/schema#", | ||
| − | "$id": "http://ecrin.org/json_schemas/mdrstudy/ | + | "$id": "http://ecrin.org/json_schemas/mdrstudy/v4.json", |
"title": "XDC Study definition", | "title": "XDC Study definition", | ||
| − | "description": "ECRIN Metadata Repository for clinical research objects, Study JSON definition, version 4 | + | "description": "ECRIN Metadata Repository for clinical research objects, Study JSON definition, version 4 September 2020", |
| − | |||
"type": "object", | "type": "object", | ||
"required": ["id", "display_title"], | "required": ["id", "display_title"], | ||
| Line 39: | Line 38: | ||
}, | }, | ||
| − | + | "brief_description": { | |
"type": "string", | "type": "string", | ||
"description": "Brief description, usually a few lines, of the study" | "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" | ||
}, | }, | ||
| Line 48: | Line 53: | ||
"description": "A statement from the sponsor and / or study leads about their intentions for IPD sharing" | "description": "A statement from the sponsor and / or study leads about their intentions for IPD sharing" | ||
}, | }, | ||
| − | + | ||
| − | "study_type": { | + | "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", | "type": "object", | ||
"properties": { | "properties": { | ||
| Line 77: | Line 88: | ||
}, | }, | ||
| − | + | "study_enrolment": { | |
"type": "integer", | "type": "integer", | ||
"description": "The anticipated or actual total number of participants in the clinical study." | "description": "The anticipated or actual total number of participants in the clinical study." | ||
}, | }, | ||
| − | + | "study_gender_elig" { | |
"type": "object", | "type": "object", | ||
"properties": { | "properties": { | ||
| Line 96: | Line 107: | ||
}, | }, | ||
| − | + | "min_age": { | |
"type": "integer", | "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)." | "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", | "type": "object", | ||
"properties": { | "properties": { | ||
| Line 120: | Line 131: | ||
}, | }, | ||
| − | + | "max_age_units": { | |
"type": "object", | "type": "object", | ||
"properties": { | "properties": { | ||
| Line 216: | Line 227: | ||
"$ref": "#/definitions/lang_code" | "$ref": "#/definitions/lang_code" | ||
}, | }, | ||
| − | + | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
"comments": { | "comments": { | ||
"type": "string" | "type": "string" | ||
| Line 242: | Line 248: | ||
}, | }, | ||
| − | + | "feature_type": { | |
"type": "object", | "type": "object", | ||
"properties": { | "properties": { | ||
| Line 348: | Line 354: | ||
} | } | ||
}, | }, | ||
| − | " | + | "target_id": { |
"type": "integer", | "type": "integer", | ||
"description": "The id, i.e. internal accession number, of the related study" | "description": "The id, i.e. internal accession number, of the related study" | ||
| Line 362: | Line 368: | ||
"description": "The id, i.e. internal accession number, of the linked data object" | "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" | ||
| + | }, | ||
}, | }, | ||
Latest revision as of 08:54, 14 September 2020
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"
},
"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"
}
}
}
}
}
}
