{ "$id": "https://schema.aireadi.org/v0.1.0/study_description.json", "$schema": "http://json-schema.org/draft-07/schema", "title": "Study Description", "description": "This is the schema for the study_description.json metadata file from the Clinical Multimodal Data Structure (CMDS). It is based on the ClinicalTrials.gov study protocol registration schema, unless specified otherwise in $comment. The keys are based on the the Clinicaltrials.gov JSON study record (https://classic.clinicaltrials.gov/api/info/study_structure?fmt=JSON) where we kept only the keys relevant to the study protocol registration as per the Clinicaltrials.gov Data Elements (https://prsinfo.clinicaltrials.gov/definitions.html). The descriptions, requirements, and controlled lists are based on the Clinicaltrials.gov Data Elements (https://prsinfo.clinicaltrials.gov/definitions.html) and extended with the ClinicalTrials.gov XML schema descriptor (https://prsinfo.clinicaltrials.gov/ProtocolRecordSchema.xsd) when necessary. Character limits have been removed unless otherwise specified. Note that the 'BriefTitle', 'OutcomesModule', 'IPDSharingStatementModule', and 'ReferencesModule' properties from ClinicalTrials.gov are not included as they were not deemed relevant for the use case in the CMDS. Some keys, values in controlled lists, etc. are from the the ECRIN Metadata Schema for study v6.0. We have also introduced some modifications as necessary for tailoring the schema to clinical research datasets. All keys are camelCase.", "type": "object", "additionalProperties": false, "properties": { "schema": { "description": "Link to the schema to be included so that users of the resulting JSON file can find the related schema easily", "type": "string", "const": "https://schema.aireadi.org/v0.1.0/study_description.json" }, "identificationModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#identification", "type": "object", "additionalProperties": false, "properties": { "officialTitle": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "type": "string", "description": "The title of the clinical study" }, "acronym": { "type": "string", "description": "An acronym or abbreviation used publicly to identify the clinical study, if any" }, "orgStudyIdInfo": { "type": "object", "additionalProperties": false, "properties": { "orgStudyId": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "type": "string", "description": "Main unique identifier assigned to the study.", "minLength": 1 }, "orgStudyIdType": { "$comment": "Description has been added here (based on SecondaryIdType) since this property is included in the ClinicalTrials.gov JSON study record but not in the Data Elements", "$ref": "#/definitions/studyIdType", "description": "A description of the type of main ID." }, "orgStudyIdDomain": { "$comment": "Description has been added here (based on SecondaryIdDomain) since this property is included in the ClinicalTrials.gov JSON study record but not in the Data Elements", "type": "string", "description": "If an ID Type of 'Other Grant/Funding Number', 'Registry Identifier', or 'Other Identifier' is selected, provide the name of the funding organization, clinical trial registry, or organization that issued the identifier", "minLength": 1 }, "orgStudyIdLink": { "$comment": "Description has been added here (based on SecondaryIdLink) since this property is included in the ClinicalTrials.gov JSON study record but not in the Data Elements", "type": "string", "description": "If the ID has a resolvable link, optionally provide the full link here. For instance, if ID is 'K01HL147713' then the ID link is 'https://reporter.nih.gov/quickSearch/K01HL147713'", "format": "uri", "minLength": 1 } }, "required": ["orgStudyId", "orgStudyIdType"], "if": { "properties": { "orgStudyIdType": { "enum": [ "Other Grant/Funding Number", "Registry Identifier", "Other Identifier" ] } } }, "then": { "required": ["orgStudyIdDomain"] } }, "secondaryIdInfoList": { "type": "array", "items": { "type": "object", "additionalProperties": false, "properties": { "secondaryId": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "type": "string", "description": "An identifier, if any, other than the main identifier.", "minLength": 1 }, "secondaryIdType": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "$ref": "#/definitions/studyIdType", "description": "A description of the type of secondary ID." }, "secondaryIdDomain": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "type": "string", "description": "If an ID Type of 'Other Grant/Funding Number,' 'Registry Identifier,' or 'Other Identifier' is selected, provide the name of the funding organization, clinical trial registry, or organization that issued the identifier.", "minLength": 1 }, "secondaryIdLink": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "type": "string", "format": "uri", "description": "If the ID has a resolvable link, optionally provide the full link here. For instance, if ID is 'K01HL147713' then the ID link is 'https://reporter.nih.gov/quickSearch/K01HL147713'", "minLength": 1 } }, "required": ["secondaryId", "secondaryIdType"], "if": { "properties": { "secondaryIdType": { "enum": [ "Other Grant/Funding Number", "Registry Identifier", "Other Identifier" ] } } }, "then": { "required": ["secondaryIdDomain"] } }, "minItems": 1, "uniqueItems": true } }, "required": ["orgStudyIdInfo"] }, "statusModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#status", "type": "object", "additionalProperties": false, "properties": { "overallStatus": { "$ref": "#/definitions/statusOptions", "description": "The recruitment status for the clinical study as a whole, based upon the status of the individual sites. If at least one facility in a multi-site clinical study has an Individual Site Status of 'Recruiting', then the Overall Recruitment Status for the study must be 'Recruiting'." }, "whyStopped": { "type": "string", "description": "A brief explanation of the reason(s) why such clinical study was stopped (for a clinical study that is 'Suspended', 'Terminated', or 'Withdrawn' prior to its planned completion as anticipated by the protocol)", "minLength": 1 }, "startDateStruct": { "type": "object", "additionalProperties": false, "description": "The estimated date on which the clinical study will be open for recruitment of participants, or the actual date on which the first participant was enrolled. Note: 'Enrolled' means a participant's, or their legally authorized representative's, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol.", "properties": { "startDate": { "$comment": "The date format is from the XML schema descriptor. This has been added here in the description.", "type": "string", "description": "Format must be 'YYYY-MM'", "format": "date", "minLength": 1 }, "startDateType": { "$comment": "Description added here", "description": "Specify if the start date is actual or anticipated", "type": "string", "enum": ["Actual", "Anticipated"] } }, "required": ["startDate", "startDateType"] }, "completionDateStruct": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "type": "object", "additionalProperties": false, "description": "The date the final participant was examined or received an intervention for purposes of final collection of data (for example, last participant's last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated. If the study is not completed yet, an anticipated date can be provided.", "properties": { "completionDate": { "$comment": "The date format is from the XML schema descriptor. This has been added here in the description.", "type": "string", "description": "Format must be 'YYYY-MM'", "format": "date", "minLength": 1 }, "completionDateType": { "$comment": "Description added here", "description": "Specify if the start date is actual or anticipated", "type": "string", "enum": ["Actual", "Anticipated"] } }, "required": ["completionDate", "completionDateType"] } }, "required": ["overallStatus", "startDateStruct", "completionDateStruct"] }, "sponsorCollaboratorsModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#sponsors", "type": "object", "additionalProperties": false, "properties": { "leadSponsor": { "type": "object", "additionalProperties": false, "properties": { "leadSponsorName": { "type": "string", "description": "The name of the entity or the individual who is the sponsor of the clinical study. Note: When a clinical study is conducted under an investigational new drug application (IND) or investigational device exemption (IDE), the IND or IDE holder is considered the sponsor. When a clinical study is not conducted under an IND or IDE, the single person or entity who initiates the study, by preparing and/or planning the study, and who has authority and control over the study, is considered the sponsor.", "minLength": 1 }, "leadSponsorIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify sponsor and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "object", "additionalProperties": false, "properties": { "leadSponsorIdentifierValue": { "type": "string", "description": "Uniquely identifies sponsor, according to various schemes.", "minLength": 1, "examples": ["https://ror.org/04aj4c18"] }, "leadSponsorIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the identifier scheme.", "examples": ["ROR"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the name identifier scheme.", "examples": ["https://ror.org"] } }, "required": [ "leadSponsorIdentifierValue", "leadSponsorIdentifierScheme" ] } }, "required": ["leadSponsorName"] }, "responsibleParty": { "type": "object", "additionalProperties": false, "properties": { "responsiblePartyType": { "description": "An indication of whether the responsible party is the sponsor, the sponsor-investigator, or a principal investigator designated by the sponsor to be the responsible party. The sponsor may designate a principal investigator as the responsible party if such principal investigator meets all of the following requirements: is responsible for conducting the study; has access to and control over the data from the study; has the right to publish the results of the study; and has the ability to meet all of the requirements for submitting and updating clinical study information.", "type": "string", "oneOf": [ { "const": "Sponsor", "description": "The entity (for example, corporation or agency) that initiates the study." }, { "const": "Principal Investigator", "description": "The individual designated as a responsible party by the sponsor." }, { "const": "Sponsor-Investigator", "description": "The individual who both initiates and conducts the study." } ] }, "responsiblePartyInvestigatorFirstName": { "$comment": "Name split into first and last here", "type": "string", "description": "First name of the investigator. Required if ResponsiblePartyType is 'Principal Investigator' or 'Sponsor-Investigator'", "minLength": 1, "examples": ["James"] }, "responsiblePartyInvestigatorLastName": { "$comment": "Name split into first and last here", "type": "string", "description": "Last name of the investigator. Required if ResponsiblePartyType is 'Principal Investigator' or 'Sponsor-Investigator'", "minLength": 1, "examples": ["Smith"] }, "responsiblePartyInvestigatorTitle": { "type": "string", "description": "The official title of the investigator at the primary organizational affiliation (required if ResponsiblePartyType is 'Principal Investigator' or 'Sponsor-Investigator')", "minLength": 1, "examples": ["Professor of Medicine"] }, "responsiblePartyInvestigatorIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify the investigator and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "array", "description": "Uniquely identifies an investigator, according to various schemes.", "items": { "type": "object", "additionalProperties": false, "properties": { "responsiblePartyInvestigatorIdentifierValue": { "type": "string", "minLength": 1, "description": "Uniquely identifies an investigator.", "examples": ["https://orcid.org/0000-0001-5727-2427"] }, "responsiblePartyInvestigatorIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the name identifier scheme.", "examples": ["ORCID"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the name identifier scheme.", "examples": ["https://orcid.org"] } }, "required": [ "responsiblePartyInvestigatorIdentifierValue", "responsiblePartyInvestigatorIdentifierScheme" ] }, "uniqueItems": true }, "responsiblePartyInvestigatorAffiliation": { "$comment": "Made into an object. Description is based on the ClinicalTrials.gov Data Elements but modified for clarity ('investigator' used instead of 'individual')", "description": "Primary organizational affiliation of the investigator (required if ResponsiblePartyType is 'Principal Investigator' or 'Sponsor-Investigator')", "type": "object", "additionalProperties": false, "properties": { "responsiblePartyInvestigatorAffiliationName": { "$comment": "Key added to fit the name in the object", "type": "string", "description": "The name of the affiliation of the investigator", "minLength": 1, "examples": ["University of California, San Diego"] }, "responsiblePartyInvestigatorAffiliationIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify sponsor and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "object", "additionalProperties": false, "properties": { "responsiblePartyInvestigatorAffiliationIdentifierValue": { "type": "string", "description": "Uniquely identifies affiliation, according to various schemes.", "minLength": 1, "examples": ["https://ror.org/04aj4c18"] }, "responsiblePartyInvestigatorAffiliationIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the identifier scheme.", "examples": ["ROR"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the name identifier scheme.", "examples": ["https://ror.org"] } }, "required": [ "responsiblePartyInvestigatorAffiliationIdentifierValue", "responsiblePartyInvestigatorAffiliationIdentifierScheme" ] } }, "required": ["responsiblePartyInvestigatorAffiliationName"] } }, "required": ["responsiblePartyType"], "if": { "properties": { "responsiblePartyType": { "enum": ["Principal Investigator", "Sponsor-Investigator"] } } }, "then": { "required": [ "responsiblePartyInvestigatorFirstName", "responsiblePartyInvestigatorLastName", "responsiblePartyInvestigatorTitle", "responsiblePartyInvestigatorAffiliation" ] } }, "collaboratorList": { "type": "array", "description": "Other organizations (if any) providing support. Support may include funding, design, implementation, data analysis or reporting. The responsible party is responsible for confirming all collaborators before listing them.", "items": { "type": "object", "additionalProperties": false, "properties": { "collaboratorName": { "$comment": "Description added here since the ClinicalTrials.gov Data Elements document only provide a high-level description of the collaborators", "type": "string", "description": "The name of the collaborating organization" }, "collaboratorNameIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify collaborator and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "object", "additionalProperties": false, "properties": { "collaboratorNameIdentifierValue": { "type": "string", "description": "Uniquely identifies the collaborating organization, according to various schemes.", "minLength": 1, "examples": ["https://ror.org/04aj4c18"] }, "collaboratorNameIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the identifier scheme.", "examples": ["ROR"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the name identifier scheme.", "examples": ["https://ror.org"] } }, "required": [ "collaboratorNameIdentifierValue", "collaboratorNameIdentifierScheme" ] } }, "required": ["collaboratorName"] }, "minItems": 1, "uniqueItems": true } }, "required": ["leadSponsor", "responsibleParty"] }, "oversightModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#oversight. 'Device Product Not Approved or Cleared by U.S. FDA', 'Post Prior to U.S. FDA Approval or Clearance', 'Pediatric Postmarket Surveillance of a Device Product', 'Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) Information' (and subitems), and 'Product Manufactured in and Exported from the U.S.' Data Elements were not kept here as they were deemed not relevant for datasets. ", "type": "object", "additionalProperties": false, "properties": { "isFDARegulatedDrug": { "type": "string", "description": "Indication that a clinical study is studying a drug product (including a biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of the Public Health Service Act.", "enum": ["Yes", "No"] }, "isFDARegulatedDevice": { "type": "string", "description": "Indication that a clinical study is studying a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act.", "enum": ["Yes", "No"] }, "humanSubjectReviewStatus": { "$comment": "This key is not in the ClinicalTrials.gov JSON study record but it has been added here to match the corresponding the Data Elements. 'Board Approval Number', 'Board Name', 'Board Affiliation', and 'Board Contact' Data Elements were not kept here as they were deemed not relevant for datasets.", "description": "Indicate whether a clinical study has been reviewed and approved by at least one human subjects protection review board or such review is not required per applicable law (for example, 21 CFR Part 56, 45 CFR Part 46, or other applicable regulation)", "$ref": "#/definitions/humanSubjectReviewStatus" }, "oversightHasDMC": { "type": "string", "description": "Indicate whether a data monitoring committee has been appointed for this study. The data monitoring committee (board) is a group of independent scientists who are appointed to monitor the safety and scientific integrity of a human research intervention, and to make recommendations to the sponsor regarding the stopping of the trial for efficacy, for harms or for futility. The composition of the committee is dependent upon the scientific skills and knowledge required for monitoring the particular study.", "enum": ["Yes", "No"] } }, "required": ["humanSubjectReviewStatus"] }, "descriptionModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#description", "type": "object", "additionalProperties": false, "properties": { "briefSummary": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets. Character limit has been kept here to ensure the summary is brief.", "type": "string", "description": "A short description of the clinical study, written in language intended for the lay public. Limit: 5000 characters", "minLength": 1, "maxLength": 5000 }, "detailedDescription": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "type": "string", "description": "Extended description of the study, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures.", "minLength": 1 } }, "required": ["briefSummary"] }, "conditionsModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#Conditions", "type": "object", "additionalProperties": false, "properties": { "conditionList": { "$comment": "Besides 'conditionName' all keys have been added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely map condition names to controlled vocabulary and make schema more FAIR. Descriptions and examples are based on the dataset_description schema but modified to suit here.", "type": "array", "description": "The name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT), that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus.", "items": { "type": "object", "additionalProperties": false, "properties": { "conditionName": { "type": "string", "description": "Name of the condition", "minLength": 1, "examples": ["Diabetes mellitus"] }, "conditionIdentifier": { "type": "object", "additionalProperties": false, "properties": { "conditionClassificationCode": { "type": "string", "minLength": 1, "description": "The classification code used for the condition name in the scheme", "examples": ["45636-8"] }, "conditionScheme": { "type": "string", "minLength": 1, "description": "The name of the scheme or classification code or authority if one is used (e.g., name of ontology) for the condition name", "examples": [ "Logical Observation Identifier Names and Codes (LOINC)" ] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the condition identifier scheme", "examples": ["https://loinc.org/"] }, "conditionURI": { "type": "string", "minLength": 1, "description": "The URI of the condition name in the scheme", "examples": ["https://loinc.org/45636-8"] } }, "required": ["conditionClassificationCode", "conditionScheme"] } }, "required": ["conditionName"] }, "minItems": 1, "uniqueItems": true }, "keywordList": { "type": "array", "description": "Words or phrases that best describe the study. Use NLM's Medical Subject Heading (MeSH)-controlled vocabulary terms or terms from another vocabulary where appropriate. Be as specific and precise as possible. Avoid acronyms and abbreviations.", "items": { "type": "object", "additionalProperties": false, "properties": { "keywordValue": { "type": "string", "description": "Keyword or phrase", "minLength": 1, "examples": ["Artificial intelligence"] }, "keywordIdentifier": { "$comment": "Added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely map condition keywords to controlled vocabulary and make schema more FAIR. Descriptions and examples are based on the dataset_description schema but modified to suit here. Description has been modified to allow terms from another vocabulary than MeSH", "type": "object", "additionalProperties": false, "properties": { "keywordClassificationCode": { "type": "string", "minLength": 1, "description": "The classification code used for the keyword in the scheme", "examples": ["D001185"] }, "keywordScheme": { "type": "string", "minLength": 1, "description": "The name of the scheme or classification code or authority if one is used (e.g., name of ontology) for the keyword", "examples": ["Medical Subject Headings (MeSH)"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the keyword identifier scheme", "examples": ["https://meshb.nlm.nih.gov/"] }, "keywordURI": { "type": "string", "minLength": 1, "description": "The URI of the keyword in the scheme", "examples": [ "https://meshb.nlm.nih.gov/record/ui?ui=D001185" ] } }, "required": ["keywordClassificationCode", "keywordScheme"] } }, "required": ["keywordValue"] }, "minItems": 1, "uniqueItems": true } }, "required": ["conditionList"] }, "designModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#StudyDesign", "type": "object", "required": ["studyType"], "properties": { "studyType": { "$comment": "Maps to https://prsinfo.clinicaltrials.gov/definitions.html#StudyType", "type": "string", "description": "The nature of the investigation", "oneOf": [ { "const": "Interventional", "description": "A clinical trial. Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes." }, { "const": "Observational", "description": "Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention." }, { "$comment": "Description changed to suit dataset", "const": "Expanded Access", "description": "An investigational drug product (including biological product) available through expanded access for patients who do not qualify for enrollment in a clinical trial. Expanded Access includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including emergency use; (2) for intermediate-size patient populations; and (3) under a treatment IND or treatment protocol." } ] } }, "allOf": [ { "if": { "properties": { "studyType": { "const": "Interventional" } } }, "then": { "properties": { "designInfo": { "type": "object", "description": "A description of the manner in which the clinical trial will be conducted.", "additionalProperties": false, "properties": { "designAllocation": { "type": "string", "description": "The process by which participants are assigned to a clinical study. Types of allocation include randomized and nonrandomized. Interventions in a nonrandomized study are not assigned randomly.", "oneOf": [ { "const": "N/A", "description": "For a single-arm trial" }, { "const": "Randomized", "description": "Participants are assigned to intervention groups by chance." }, { "const": "Non-randomized", "description": "Participants are expressly assigned to intervention groups through a non-random method, such as physician choice." } ] }, "designInterventionModel": { "type": "string", "description": "The strategy for assigning interventions to participants.", "oneOf": [ { "const": "Treatment", "description": "One or more interventions are being evaluated for treating a disease, syndrome, or condition." }, { "const": "Prevention", "description": "One or more interventions are being assessed for preventing the development of a specific disease or health condition." }, { "const": "Diagnostic", "description": "One or more interventions are being evaluated for identifying a disease or health condition." }, { "const": "Supportive Care", "description": "One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function." }, { "const": "Screening", "description": "One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor." }, { "const": "Health Services Research", "description": "One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare." }, { "const": "Basic Science", "description": "One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention)." }, { "const": "Device Feasibility", "description": "An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product, or a clinical trial to test a prototype device for feasibility and not health outcomes." } ] }, "designInterventionModelDescription": { "type": "string", "description": "Provide details about the Interventional Study Model", "minLength": 1 }, "designPrimaryPurpose": { "type": "string", "description": "The main objective of the intervention(s) being evaluated by the clinical trial.", "oneOf": [ { "const": "Single Group Assignment", "description": "Clinical trials with a single arm." }, { "const": "Parallel Assignment", "description": "Participants are assigned to one of two or more groups in parallel for the duration of the study." }, { "const": "Crossover Assignment", "description": "Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study." }, { "const": "Factorial Assignment", "description": "Two or more interventions, each alone and in combination, are evaluated in parallel against a control group." }, { "const": "Sequential Assignment", "description": "Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies." } ] }, "designMaskingInfo": { "type": "object", "description": "The party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.", "additionalProperties": false, "properties": { "designMasking": { "type": "string", "oneOf": [ { "const": "None (open label)" }, { "const": "Blinded (no details)", "description": "From a statement that says the study was blinded, but where the degree of blinding was not provided" }, { "const": "Single" }, { "const": "Double" }, { "const": "Triple" }, { "const": "Quadruple" }, { "const": "N/A", "description": "Explicitly labeled as not applicable - usually because the study is non-interventional" } ] }, "designWhoMaskedList": { "type": "array", "items": { "type": "string", "oneOf": [ { "const": "Participant" }, { "const": "Care Provider" }, { "const": "Investigator" }, { "const": "Outcomes Assessor", "description": "The individual who evaluates the outcome(s) of interest" } ] }, "minItems": 1, "uniqueItems": true }, "designMaskingDescription": { "type": "string", "description": "Provide information about other parties who may be masked in the clinical trial, if any.", "minLength": 1 } }, "required": ["designMasking", "designWhoMaskedList"] } }, "required": [ "designAllocation", "designInterventionModel", "designPrimaryPurpose", "designMaskingInfo" ] }, "phaseList": { "type": "array", "description": "For a clinical trial of a drug product (including a biological product), the numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21 and in 21 CFR 312.85 for phase 4 studies. Select only one.", "items": { "type": "string", "oneOf": [ { "const": "N/A", "description": "Trials without phases (for example, studies of devices or behavioural interventions)." }, { "const": "Early Phase 1", "description": "Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies)." }, { "const": "Phase 1", "description": "Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, side effects, and to gain early evidence of effectiveness; may include healthy participants and/or patients." }, { "const": "Phase 1/2", "description": "Trials that are a combination of phases 1 and 2." }, { "const": "Phase 2", "description": "Controlled clinical studies conducted to evaluate the effectiveness of the intervention for a particular indication in participants with the disease or condition under study, and to determine the common short-term side effects and risks." }, { "const": "Phase 2/3", "description": "Trials that are a combination of phases 2 and 3." }, { "const": "Phase 3", "description": "Trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug." }, { "const": "Phase 4", "description": "Studies of approved drugs to delineate additional information including the drug's risks, benefits, and optimal use." } ] }, "minItems": 1, "maxItems": 1, "uniqueItems": true }, "enrollmentInfo": { "$ref": "#/definitions/enrollmentInfo" }, "numberArms": { "$comment": "This key is not in the ClinicalTrials.gov JSON study record but it has been added here to match the corresponding the Data Elements", "type": "string", "pattern": "^[0-9]+$", "minLength": 1, "description": "The number of arms in the clinical trial. For a trial with multiple periods or phases that have different numbers of arms, the maximum number of arms during all periods or phases. Note: 'Arm' means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol. The minimum value is '1'" } }, "required": [ "designInfo", "phaseList", "enrollmentInfo", "numberArms" ] } }, { "if": { "properties": { "studyType": { "const": "Observational" } } }, "then": { "properties": { "isPatientRegistry": { "$comment": "This key is not in the ClinicalTrials.gov JSON study record but it has been added here to specify if an observational study is a Patient Registry.", "type": "string", "description": "Indicate if the observational study is a Patient Registry, i.e., an observational study that is also considered to be a Patient Registry. Note: The Agency for Healthcare Research and Quality (AHRQ) defines a Patient Registry as including an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, healthcare services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or on-going data collection programs that address one or more questions.", "enum": ["Yes", "No"] }, "designInfo": { "$comment": "Description has been added here since none was provided in the ClinicalTrials.gov Data Elements", "type": "object", "description": "A description of the manner in which the observational study will be conducted", "additionalProperties": false, "properties": { "designObservationalModelList": { "type": "array", "description": "Primary strategy for participant identification and follow-up.", "items": { "type": "string", "oneOf": [ { "const": "Cohort", "description": "Group of individuals, initially defined and composed, with common characteristics (for example, condition, birth year), who are examined or traced over a given time period." }, { "const": "Case-Control", "description": "Group of individuals with specific characteristics (for example, conditions or exposures) compared to group(s) with different characteristics, but otherwise similar." }, { "const": "Case-Only", "description": "Single group of individuals with specific characteristics." }, { "const": "Case-Crossover", "description": "Characteristics of a case immediately prior to disease onset (sometimes called the hazard period) compared to characteristics of the same case at a prior time (that is, control period)." }, { "const": "Ecologic or Community", "description": "Geographically defined populations, such as countries or regions within a country, compared on a variety of environmental (for example, air pollution intensity, hours of sunlight) and/or global measures not reducible to individual-level characteristics (for example, healthcare system, laws or policies median income, average fat intake, disease rate)." }, { "const": "Family-Based", "description": "Studies conducted among family members, such as genetic studies within families or twin studies and studies of a family environment." }, { "const": "Other", "description": "Explain in Detailed Description." } ] }, "minItems": 1, "uniqueItems": true }, "designTimePerspectiveList": { "type": "array", "description": "Temporal relationship of the observation period to the time of participant enrollment.", "items": { "type": "string", "oneOf": [ { "const": "Retrospective", "description": "Look back using observations collected predominantly prior to subject selection and enrollment." }, { "const": "Prospective", "description": "Look forward using periodic observations collected predominantly following subject enrollment." }, { "const": "Cross-sectional", "description": "Observations or measurements made at a single point in time, usually at subject enrollment." }, { "const": "Other", "description": "Explain in Detailed Description." } ] }, "minItems": 1, "uniqueItems": true } }, "required": [ "designObservationalModelList", "designTimePerspectiveList" ] }, "bioSpec": { "$comment": "Made mandatory here", "type": "object", "additionalProperties": false, "properties": { "bioSpecRetention": { "type": "string", "description": "Indicate whether samples of material from research participants are retained in a biorepository.", "oneOf": [ { "const": "None Retained", "description": "No samples retained" }, { "const": "Samples With DNA", "description": "Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (e.g., frozen tissue, whole blood)" }, { "const": "Samples Without DNA", "description": "Samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)" } ] }, "bioSpecDescription": { "type": "string", "description": "Specify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue).", "minLength": 1 } }, "required": ["bioSpecRetention", "bioSpecDescription"] }, "enrollmentInfo": { "$ref": "#/definitions/enrollmentInfo" }, "targetDuration": { "type": "string", "description": "For Patient Registries, the anticipated time period over which each participant is to be followed.", "minLength": 1, "pattern": "^[0-9]+(\\.[0-9]+)?\\s*(Years|Months|Weeks|Days|Hours)?$" } }, "required": [ "isPatientRegistry", "designInfo", "bioSpec", "enrollmentInfo" ], "if": { "properties": { "isPatientRegistry": { "const": "Yes" } } }, "then": { "required": ["targetDuration"] } } } ] }, "armsInterventionsModule": { "$comment": "https://prsinfo.clinicaltrials.gov/definitions.html#ArmsGroupsInterventions", "type": "object", "additionalProperties": false, "properties": { "armGroupList": { "type": "array", "items": { "type": "object", "description": "If the study is interventional: A description of each arm of the clinical trial that indicates its role in the clinical trial; provides an informative title; and, if necessary, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. || If the study is observational: Specify the predefined participant groups (cohorts) to be studied, corresponding to Number of Groups specified under Study Design (for single-group studies, the following data elements are optional). Do not use this section to specify strata (Detailed Description can be used for that purpose, if desired).", "additionalProperties": false, "properties": { "armGroupLabel": { "description": "If the study is interventional: The short name used to identify the arm. || If the study is observational: The short name used to identify the group.", "type": "string", "minLength": 1 }, "armGroupType": { "type": "string", "description": "Required only if study type is interventional", "enum": [ "Experimental", "Active Comparator", "Placebo Comparator", "Sham Comparator", "No Intervention", "Other" ] }, "armGroupDescription": { "$comment": "Made mandatory here since otherwise it would not be possible to understand the labels", "description": "If the study is interventional: If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. || Explanation of the nature of the study group (for example, those with a condition and those without a condition; those with an exposure and those without an exposure).", "type": "string", "minLength": 1 }, "armGroupInterventionList": { "type": "array", "description": "Indicate which Interventions (from the intervention list) are in this Arm/Group (must match with interventionName)", "items": { "type": "string", "minLength": 1 }, "minItems": 1, "uniqueItems": true } }, "required": ["armGroupLabel", "armGroupDescription"] }, "minItems": 1, "uniqueItems": true }, "interventionList": { "$comment": "'interventionArmGroupLabelList' has been removed here since it the cross-connection information between interventions and arms/groups is already captured in 'armGroupInterventionList'", "type": "array", "description": "Specify the intervention(s) associated with each arm or group; at least one intervention must be specified for interventional studies. For observational studies, specify the intervention(s)/exposure(s) of interest, if any. If the same intervention is associated with more than one arm or group, provide the information once and use the Arm or Group/Intervention Cross-Reference to associate it with more than one arm or group.", "items": { "type": "object", "additionalProperties": false, "properties": { "interventionType": { "type": "string", "description": "For each intervention studied in the clinical study, the general type of intervention. Select one.", "oneOf": [ { "const": "Drug", "description": "Including placebo" }, { "const": "Device", "description": "Including sham" }, { "const": "Biological/Vaccine", "description": "" }, { "const": "Procedure/Surgery", "description": "" }, { "const": "Radiation", "description": "" }, { "const": "Behavioral", "description": "For example, psychotherapy, lifestyle counseling" }, { "const": "Genetic", "description": "Including gene transfer, stem cell and recombinant DNA" }, { "const": "Dietary Supplement", "description": "For example, vitamins, minerals" }, { "const": "Combination Product", "description": "Combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and device" }, { "const": "Diagnostic Test", "description": "For example, imaging, in-vitro" }, { "const": "Other", "description": "" } ] }, "interventionName": { "type": "string", "description": "A brief descriptive name used to refer to the intervention(s) studied in each arm of the clinical study. A non-proprietary name of the intervention must be used, if available. If a non-proprietary name is not available, a brief descriptive name or identifier must be used.", "minLength": 1 }, "interventionDescription": { "type": "string", "description": "Details that can be made public about the intervention, other than the Intervention Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention from other, similar interventions studied in the same or another clinical study. For example, interventions involving drugs may include dosage form, dosage, frequency, and duration", "minLength": 1 }, "interventionOtherNameList": { "type": "array", "description": "Other current and former name(s) or alias(es), if any, different from the Intervention Name(s), that the sponsor has used publicly to identify the intervention(s), including, but not limited to, past or present names such as brand name(s), or serial numbers.", "items": { "type": "string", "minLength": 1 }, "minItems": 1, "uniqueItems": true } }, "required": [ "interventionType", "interventionName", "interventionDescription" ] }, "minItems": 1, "uniqueItems": true } }, "required": ["armGroupList", "interventionList"] }, "eligibilityModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#Eligibility", "type": "object", "additionalProperties": false, "properties": { "sex": { "type": "string", "description": "The sex and, if applicable, gender of the participants eligible to participate in the clinical study. The sex of the participants eligible to participate in the clinical study. Note: 'Sex' means a person's classification as male or female based on biological distinctions.", "oneOf": [ { "const": "All", "description": "Indicates no limit on eligibility based on the sex of participants" }, { "const": "Female", "description": "Indicates that only female participants are being studied" }, { "const": "Male", "description": "Indicates that only male participants are being studied" } ] }, "genderBased": { "type": "string", "description": "If applicable, indicate whether participant eligibility is based on gender. Note: 'Gender' means a person's self-representation of gender identity.", "enum": ["Yes", "No"] }, "genderDescription": { "type": "string", "description": "If eligibility is based on gender, provide descriptive information about Gender criteria." }, "minimumAge": { "type": "string", "description": "The numerical value, if any, for the minimum age a potential participant must meet to be eligible for the clinical study. Include a whole number followed by units, if no limit use 'N/A' - see controlled values for units", "pattern": "^[0-9]+(\\.[0-9]+)?\\s*(Years|Months|Weeks|Days|Hours|N/A)?$", "minLength": 1 }, "maximumAge": { "type": "string", "description": "The numerical value, if any, for the maximum age a potential participant must meet to be eligible for the clinical study. Include a whole number followed by units, if no limit use 'N/A' - see controlled values for units", "pattern": "^[0-9]+(\\.[0-9]+)?\\s*(Years|Months|Weeks|Days|Hours|N/A)?$", "minLength": 1 }, "healthyVolunteers": { "$comment": "Made mandatory for both interventional and observational studies", "type": "string", "description": "Indication that participants who do not have a disease or condition, or related conditions or symptoms, under study in the clinical study are permitted to participate in the clinical study.", "enum": ["Yes", "No"] }, "eligibilityCriteria": { "$comment": "This is a string in the ClinicalTrials.gov JSON study record but made an object here to better separate inclusion and exclusion criteria. Description has been modified to suit datasets.", "type": "object", "description": "A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria.", "properties": { "eligibilityCriteriaInclusion": { "type": "array", "items": { "type": "string", "description": "An inclusion criterion", "minLength": 1 }, "minItems": 1, "uniqueItems": true }, "eligibilityCriteriaExclusion": { "items": { "type": "string", "description": "An exclusion criterion", "minLength": 1 }, "minItems": 1, "uniqueItems": true } }, "required": [ "eligibilityCriteriaInclusion", "eligibilityCriteriaExclusion" ] }, "studyPopulation": { "type": "string", "description": "A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town). Required for observational studies only.", "minLength": 1 }, "samplingMethod": { "type": "string", "description": "The method used to select participants to be studied. Required for observational studies only.", "oneOf": [ { "const": "Probability Sample", "description": "Exclusively random process to guarantee that each participant or population has specified chance of selection, such as simple random sampling, systematic sampling, stratified random sampling, cluster sampling, and consecutive participant sampling" }, { "const": "Non-Probability Sample", "description": "Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer" } ] } }, "required": [ "sex", "genderBased", "minimumAge", "maximumAge", "healthyVolunteers", "eligibilityCriteria" ] }, "contactsLocationsModule": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#Locations", "type": "object", "additionalProperties": false, "properties": { "centralContactList": { "$comment": "Description is based on the ClinicalTrials.gov Data Elements but modified to suit datasets", "type": "array", "description": "The contact of a person to whom questions about the study can be addressed.", "items": { "type": "object", "additionalProperties": false, "properties": { "centralContactFirstName": { "$comment": "Added in lieu of centralContactName", "type": "string", "minLength": 1 }, "centralContactLastName": { "$comment": "Added in lieu of centralContactName", "type": "string", "minLength": 1 }, "centralContactDegree": { "$comment": "Added here", "type": "string", "minLength": 1 }, "centralContactIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify the central contact and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "array", "description": "Uniquely identifies a central contract, according to various schemes.", "items": { "type": "object", "additionalProperties": false, "properties": { "centralContactIdentifierValue": { "type": "string", "minLength": 1, "description": "Uniquely identifies an central contact.", "examples": ["https://orcid.org/0000-0001-5727-2427"] }, "centralContactIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the central contact identifier scheme.", "examples": ["ORCID"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the central contact identifier scheme.", "examples": ["https://orcid.org"] } }, "required": [ "centralContactIdentifierValue", "centralContactIdentifierScheme" ] }, "uniqueItems": true }, "centralContactAffiliation": { "type": "object", "additionalProperties": false, "properties": { "centralContactAffiliationName": { "type": "string", "description": "The name of the affiliation of the central contact", "minLength": 1 }, "centralContactAffiliationIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify central contact affiliation and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "object", "additionalProperties": false, "properties": { "centralContactAffiliationIdentifierValue": { "type": "string", "description": "Uniquely identifies central contact affiliation, according to various schemes.", "minLength": 1, "examples": ["https://ror.org/04aj4c18"] }, "centralContactAffiliationIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the identifier scheme.", "examples": ["ROR"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the name identifier scheme.", "examples": ["https://ror.org"] } }, "required": [ "centralContactAffiliationIdentifierValue", "centralContactAffiliationIdentifierScheme" ] } }, "required": ["centralContactAffiliationName"] }, "centralContactPhone": { "type": "string", "description": "Toll-free phone number of the Central Contact Person. Use the format 800-555-5555 within the United States and Canada. If outside the United States and Canada, provide the full phone number, including the country code. 30 characters", "minLength": 1, "maxLength": 30 }, "centralContactPhoneExt": { "type": "string", "description": "phone extension, if needed.", "minLength": 1 }, "centralContactEMail": { "type": "string", "description": "Email address of the Central Contact Person", "minLength": 1 } }, "required": [ "centralContactFirstName", "centralContactLastName", "centralContactAffiliation", "centralContactEMail" ] }, "minItems": 1, "uniqueItems": true }, "overallOfficialList": { "type": "array", "description": "Person(s) responsible for the overall scientific leadership of the protocol, including study principal investigator.", "items": { "type": "object", "additionalProperties": false, "properties": { "overallOfficialFirstName": { "type": "string", "minLength": 1 }, "overallOfficialLastName": { "type": "string", "minLength": 1 }, "overallOfficialDegree": { "type": "string", "minLength": 1 }, "overallOfficialIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify the official and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "array", "description": "Uniquely identifies an official, according to various schemes.", "items": { "type": "object", "additionalProperties": false, "properties": { "overallOfficialIdentifierValue": { "type": "string", "minLength": 1, "description": "Uniquely identifies an official.", "examples": ["https://orcid.org/0000-0001-5727-2427"] }, "overallOfficialIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the official identifier scheme.", "examples": ["ORCID"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the official identifier scheme.", "examples": ["https://orcid.org"] } }, "required": [ "overallOfficialIdentifierValue", "overallOfficialIdentifierScheme" ] }, "uniqueItems": true }, "overallOfficialAffiliation": { "type": "object", "additionalProperties": false, "properties": { "overallOfficialAffiliationName": { "type": "string", "description": "Full name of the official's organization.", "minLength": 1 }, "overallOfficialAffiliationIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify official affiliation and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "object", "additionalProperties": false, "properties": { "overallOfficialAffiliationIdentifierValue": { "type": "string", "description": "Uniquely identifies official affiliation, according to various schemes.", "minLength": 1, "examples": ["https://ror.org/04aj4c18"] }, "overallOfficialAffiliationIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the identifier scheme.", "examples": ["ROR"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the name identifier scheme.", "examples": ["https://ror.org"] } }, "required": [ "overallOfficialAffiliationIdentifierValue", "overallOfficialAffiliationIdentifierScheme" ] } }, "required": ["overallOfficialAffiliationName"] }, "overallOfficialRole": { "type": "string", "description": "Position or function of the official.", "enum": [ "Study Chair", "Study Director", "Study Principal Investigator" ] } }, "required": [ "overallOfficialFirstName", "overallOfficialLastName", "overallOfficialAffiliation", "overallOfficialRole" ] }, "minItems": 1, "uniqueItems": true }, "locationList": { "type": "array", "items": { "type": "object", "additionalProperties": false, "properties": { "locationFacility": { "type": "string", "description": "Full name of the organization where the clinical study is being conducted.", "minLength": 1 }, "locationStatus": { "$ref": "#/definitions/statusOptions", "description": "The recruitment status of each participating facility in a clinical study." }, "locationCity": { "type": "string", "description": "City of the location of the clinical study.", "minLength": 1 }, "locationState": { "type": "string", "description": "State or province of the location of the clinical study. Required for U.S. locations (including territories of the United States)", "minLength": 1 }, "locationZip": { "type": "string", "description": "Zip or postal code of the location of the clinical study. Required for U.S. locations (including territories of the United States)", "minLength": 1 }, "locationCountry": { "type": "string", "description": "Country of the location of the clinical study.", "minLength": 1 }, "locationIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify location and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "object", "additionalProperties": false, "properties": { "locationIdentifierValue": { "type": "string", "description": "Uniquely identifies location, according to various schemes.", "minLength": 1, "examples": ["https://ror.org/04aj4c18"] }, "locationIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the identifier scheme.", "examples": ["ROR"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the name identifier scheme.", "examples": ["https://ror.org"] } }, "required": [ "locationIdentifierValue", "locationIdentifierScheme" ] }, "locationContactList": { "type": "array", "description": "Required if Central Contact is not provided", "items": { "type": "object", "description": "For each facility participating in a clinical study, including the name or title, telephone number, and email address of a person to whom questions concerning the study and enrollment at that site can be addressed. Include the following information.", "additionalProperties": false, "properties": { "locationContactFirstName": { "type": "string", "minLength": 1 }, "locationContactLastName": { "type": "string", "minLength": 1 }, "locationContactIdentifier": { "$comment": "Key added based on the dataset_description.json schema https://schema.aireadi.org/files/dataset_description.json (which is based on DataCite) to uniquely identify the location contact and make schema more FAIR. Description and examples are based on the dataset_description schema but modified to suit here.", "type": "array", "description": "Uniquely identifies a location contract, according to various schemes.", "items": { "type": "object", "additionalProperties": false, "properties": { "locationContactIdentifierValue": { "type": "string", "minLength": 1, "description": "Uniquely identifies a location contact.", "examples": [ "https://orcid.org/0000-0001-5727-2427" ] }, "locationContactIdentifierScheme": { "type": "string", "minLength": 1, "description": "The name of the location contact identifier scheme.", "examples": ["ORCID"] }, "schemeURI": { "type": "string", "minLength": 1, "description": "The URI of the location contact identifier scheme.", "examples": ["https://orcid.org"] } }, "required": [ "centralContactIdentifierValue", "locationContactIdentifierScheme" ] }, "uniqueItems": true }, "locationContactRole": { "type": "string", "description": "Position or function of the contact person.", "enum": ["Principal Investigator", "Sub-Investigator"] }, "locationContactPhone": { "type": "string", "description": "Office phone of the Facility Contact.", "minLength": 1 }, "locationContactPhoneExt": { "type": "string", "description": "phone extension, if needed.", "minLength": 1 }, "locationContactEMail": { "type": "string", "description": "Electronic mail address of the facility contact person", "minLength": 1 } }, "required": [ "locationContactFirstName", "locationContactLastName", "locationContactRole", "locationContactPhone", "locationContactEMail" ] }, "minItems": 1, "uniqueItems": true } }, "required": [ "locationFacility", "locationStatus", "locationCity", "locationCountry" ] }, "minItems": 1, "uniqueItems": true } }, "required": ["locationList"] } }, "required": [ "schema", "identificationModule", "statusModule", "sponsorCollaboratorsModule", "descriptionModule", "designModule", "armsInterventionsModule", "conditionsModule", "eligibilityModule", "contactsLocationsModule" ], "definitions": { "studyIdType": { "$comment": "Maps to controlled list in https://prsinfo.clinicaltrials.gov/definitions.html#SecondaryIdType. 'ClinicalTrials.gov' option has been introduced here. Descriptions have been modified to suit datasets. Could be extended in the future to include other identifier types used for clinical research studies", "type": "string", "oneOf": [ { "$comment": "Description based on https://classic.clinicaltrials.gov/ct2/about-studies/glossary#:~:text=A%20unique%20identification%20code%20given,called%20the%20ClinicalTrials.gov%20identifier.", "const": "ClinicalTrials.gov", "description": "A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is 'NCT' followed by an 8-digit number (for example, NCT00000419)." }, { "const": "U.S. National Institutes of Health (NIH) Grant/Contract Award Number", "description": "In the ID field, include activity code, institute code, and 6-digit serial number. Other components of the full award number (type code, support year, and suffix) are optional." }, { "const": "Other Grant/Funding Number", "description": "Identifier assigned by a funding organization other than the U.S. NIH; also required to enter the name of the funding organization in the ID domain field." }, { "const": "Registry Identifier", "description": "Number assigned by a clinical trial registry (for example, a registry that is part of the World Health Organization [WHO] Registry Network); also required to enter the name of the clinical trial registry in the ID domain field." }, { "const": "EudraCT Number", "description": "Identifier assigned by the European Medicines Agency Clinical Trials Database (EudraCT)." }, { "const": "Other Identifier", "description": "Also required to enter a brief description of the identifier (for example, the name of the organization that issued the identifier) in the ID domain field." } ] }, "statusOptions": { "$comment": "Maps to controlled list in https://prsinfo.clinicaltrials.gov/definitions.html#OverallStatus", "type": "string", "oneOf": [ { "const": "Withdrawn", "description": "Study halted prematurely, prior to enrolment of the first participant." }, { "const": "Recruiting", "description": "Participants are currently being recruited, whether or not any participants have yet been enrolled." }, { "const": "Active, not recruiting", "description": "Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled." }, { "const": "Not yet recruiting", "description": "Participants are not yet being recruited." }, { "const": "Suspended", "description": "Study halted prematurely but potentially will resume." }, { "const": "Enrolling by invitation", "description": "Participants are being (or will be) selected from a predetermined population." }, { "const": "Completed", "description": "The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant's last visit has occurred)." }, { "const": "Terminated", "description": "Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention." } ] }, "humanSubjectReviewStatus": { "$comment": "Maps to controlled list in https://prsinfo.clinicaltrials.gov/definitions.html#HumanSubject", "type": "string", "oneOf": [ { "const": "Request not yet submitted", "description": "Review board approval is required but has not yet been requested" }, { "const": "Submitted, pending", "description": "Review board approval has been requested but not yet granted" }, { "const": "Submitted, approved", "description": "Review board approval has been requested and obtained" }, { "const": "Exempt", "description": "An exemption in accord with applicable law and regulation has been granted" }, { "const": "Submitted, denied", "description": "Review board has denied the approval request" }, { "const": "Submission not required", "description": "Review board approval is not required because the study is not subject to laws, regulations, or applicable institutional policies requiring human subjects review" } ] }, "enrollmentInfo": { "$comment": "Maps to Data Elements in https://prsinfo.clinicaltrials.gov/definitions.html#IntEnrollment", "type": "object", "additionalProperties": false, "properties": { "enrollmentCount": { "type": "string", "pattern": "^[0-9]+$", "minLength": 1, "description": "The estimated total number of participants to be enrolled (target number) or the actual total number of participants that are enrolled in the clinical study. Note: 'Enrolled' means a participant's, or their legally authorized representative's, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for a study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol. The min value is '1'." }, "enrollmentType": { "type": "string", "enum": ["Anticipated", "Actual"] } }, "required": ["enrollmentCount", "enrollmentType"] } } }