{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$id": "https://artifacts.apis.io/amass-tech/json-schema/amass-tech-trial-core-record-schema.json",
  "title": "TrialCoreRecord",
  "x-generated": "2026-11-01",
  "x-method": "derived",
  "x-generator": "derive-json-schema.py",
  "x-source": "openapi/amass-tech-openapi.json#/components/schemas/TrialCoreRecord",
  "type": "object",
  "properties": {
    "amassId": {
      "type": "string"
    },
    "nctId": {
      "type": [
        "string",
        "null"
      ],
      "description": "ClinicalTrials.gov identifier (e.g., NCT01234567) — a unique ID assigned to each study registered on [ClinicalTrials.gov](https://clinicaltrials.gov/). Null for trials sourced from non-US registries (see registryId)."
    },
    "registryId": {
      "type": [
        "string",
        "null"
      ],
      "description": "Identifier assigned by the trial's source registry. For ClinicalTrials.gov trials this equals nctId; for trials sourced from the WHO ICTRP it is the native registry ID (e.g., EUCTR2013-000487-28-DE, ChiCTR2400080025, JPRN-UMIN000025287). Unlike nctId, this is populated for every record. EUCTR values always carry a country suffix, since EU trials register once per participating country."
    },
    "sourceRegistry": {
      "type": [
        "string",
        "null"
      ],
      "description": "Slug identifying which registry the record was sourced from: `clinicaltrials_gov` for US trials, or a WHO ICTRP member-registry slug for non-US trials (e.g., `euctr`, `ctis`, `chictr`, `isrctn`, `anzctr`, `jprn`, `ctri`, `drks`)."
    },
    "sourceUrl": {
      "type": [
        "string",
        "null"
      ],
      "description": "Link to the trial record on its source registry."
    },
    "url": {
      "type": [
        "string",
        "null"
      ],
      "description": "Link to the source of this record. The target may change over time; use the identifier fields to build links to specific external systems."
    },
    "briefTitle": {
      "type": [
        "string",
        "null"
      ]
    },
    "officialTitle": {
      "type": [
        "string",
        "null"
      ]
    },
    "briefSummary": {
      "type": [
        "string",
        "null"
      ]
    },
    "acronym": {
      "type": [
        "string",
        "null"
      ],
      "description": "Short study acronym or nickname, if assigned (e.g., \"KEYNOTE-189\", \"PACIFIC\")."
    },
    "phase": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "EARLY_PHASE1",
        "PHASE1",
        "PHASE1/PHASE2",
        "PHASE2",
        "PHASE2/PHASE3",
        "PHASE3",
        "PHASE4",
        "NA",
        null
      ],
      "description": "Clinical trial phase indicating the stage of research. See: [https://clinicaltrials.gov/study-basics/glossary#phase](https://clinicaltrials.gov/study-basics/glossary#phase)"
    },
    "overallStatus": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "RECRUITING",
        "NOT_YET_RECRUITING",
        "ENROLLING_BY_INVITATION",
        "ACTIVE_NOT_RECRUITING",
        "SUSPENDED",
        "TERMINATED",
        "COMPLETED",
        "WITHDRAWN",
        "UNKNOWN",
        "WITHHELD",
        "AVAILABLE",
        "NO_LONGER_AVAILABLE",
        "TEMPORARILY_NOT_AVAILABLE",
        "APPROVED_FOR_MARKETING",
        null
      ],
      "description": "Current recruitment or access status of the study. See: [https://clinicaltrials.gov/study-basics/glossary#recruitment-status](https://clinicaltrials.gov/study-basics/glossary#recruitment-status)"
    },
    "lastKnownStatus": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "RECRUITING",
        "NOT_YET_RECRUITING",
        "ENROLLING_BY_INVITATION",
        "ACTIVE_NOT_RECRUITING",
        "SUSPENDED",
        "TERMINATED",
        "COMPLETED",
        "WITHDRAWN",
        "UNKNOWN",
        "WITHHELD",
        "AVAILABLE",
        "NO_LONGER_AVAILABLE",
        "TEMPORARILY_NOT_AVAILABLE",
        "APPROVED_FOR_MARKETING",
        null
      ],
      "description": "When overallStatus is UNKNOWN (the sponsor has not verified the record in over two years), the status it last reported, e.g. RECRUITING. Null for any other overallStatus. ClinicalTrials.gov trials only."
    },
    "studyType": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "INTERVENTIONAL",
        "OBSERVATIONAL",
        "EXPANDED_ACCESS",
        null
      ],
      "description": "The nature of the study: INTERVENTIONAL (tests treatments), OBSERVATIONAL (monitors outcomes without intervention), or EXPANDED_ACCESS (provides access outside of trials)."
    },
    "startDate": {
      "type": [
        "string",
        "null"
      ],
      "format": "date",
      "description": "Date the study began enrolling participants."
    },
    "primaryCompletionDate": {
      "type": [
        "string",
        "null"
      ],
      "format": "date",
      "description": "Date the last participant was examined or treated for the primary outcome, which is when primary results become available. For an ongoing trial this is the sponsor's estimate. ClinicalTrials.gov trials only."
    },
    "completionDate": {
      "type": [
        "string",
        "null"
      ],
      "format": "date",
      "description": "Date the final participant completed the study (or estimated completion)."
    },
    "lastUpdateDate": {
      "type": [
        "string",
        "null"
      ],
      "format": "date",
      "description": "The date Amass last wrote this record. It moves on any ingested change, so it answers \"is what I hold current\" rather than \"did the trial's substance change\". Observed by Amass, not the registry's own claim. Not the same as the change feed's `updateDate`, which also covers posted-results revisions and removed outcome rows and can therefore be newer."
    },
    "createDate": {
      "type": [
        "string",
        "null"
      ],
      "format": "date",
      "description": "Date this record first entered Amass. May be null for records ingested before Amass tracked it."
    },
    "hasResults": {
      "type": "boolean",
      "description": "Whether the study has posted results on its source registry."
    },
    "enrollment": {
      "type": [
        "number",
        "null"
      ],
      "description": "Number of participants enrolled (or target enrollment). See enrollmentType to determine if this is actual or estimated."
    },
    "enrollmentType": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "ACTUAL",
        "ESTIMATED",
        null
      ],
      "description": "Whether the enrollment count is ACTUAL (final) or ESTIMATED (target)."
    },
    "sponsorName": {
      "type": [
        "string",
        "null"
      ]
    },
    "sponsorType": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "NIH",
        "FED",
        "INDUSTRY",
        "OTHER",
        "OTHER_GOV",
        "INDIV",
        "NETWORK",
        null
      ],
      "description": "Category of the lead sponsor: NIH, FED (other US federal agency), INDUSTRY, OTHER (e.g., university), OTHER_GOV (non-US government), INDIV (individual), or NETWORK."
    },
    "collaborators": {
      "type": "array",
      "items": {
        "type": "string"
      }
    },
    "conditions": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "Diseases or conditions studied in the trial, as specified by the sponsor."
    },
    "conditionMeshTerms": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "MeSH terms mapped to the study conditions, where available. Browse: [https://meshb.nlm.nih.gov/](https://meshb.nlm.nih.gov/)"
    },
    "interventionTypes": {
      "type": "array",
      "items": {
        "type": "string",
        "enum": [
          "DRUG",
          "DEVICE",
          "BIOLOGICAL",
          "COMBINATION_PRODUCT",
          "PROCEDURE",
          "RADIATION",
          "DIETARY_SUPPLEMENT",
          "GENETIC",
          "BEHAVIORAL",
          "DIAGNOSTIC_TEST",
          "OTHER"
        ]
      },
      "description": "Categories of interventions used in the trial (e.g., DRUG, DEVICE, BIOLOGICAL, PROCEDURE)."
    },
    "interventionNames": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "Names of the specific interventions (e.g., drug names, device names)."
    },
    "interventionMeshTerms": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "MeSH terms mapped to the study interventions, where available. Browse: [https://meshb.nlm.nih.gov/](https://meshb.nlm.nih.gov/)"
    },
    "facilityCountries": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "Countries where study facilities are located, as ISO 3166-1 alpha-2 codes (e.g., \"US\", \"DK\", \"DE\")."
    },
    "keywords": {
      "type": "array",
      "items": {
        "type": "string"
      }
    },
    "orgStudyId": {
      "type": [
        "string",
        "null"
      ],
      "description": "Unique protocol identifier assigned by the study sponsor (not the NCT ID)."
    },
    "secondaryIds": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "Additional identifiers for the study (e.g., grant numbers, EudraCT numbers, other registry IDs)."
    },
    "primaryOutcomeMeasures": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "Primary endpoints — the main results measured to determine whether the intervention worked."
    },
    "secondaryOutcomeMeasures": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "Secondary endpoints — additional results measured to evaluate other effects of the intervention."
    },
    "minAgeYears": {
      "type": [
        "integer",
        "null"
      ],
      "description": "Minimum eligible age in whole years. A limit under one year reads as 0. Null when none is stated."
    },
    "maxAgeYears": {
      "type": [
        "integer",
        "null"
      ],
      "description": "Maximum eligible age in whole years, rounded up (an 11-month limit reads as 1). Null when none is stated."
    },
    "sex": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "ALL",
        "FEMALE",
        "MALE",
        null
      ],
      "description": "Sex of the participants the trial enrolls: ALL, FEMALE, or MALE."
    },
    "healthyVolunteers": {
      "type": [
        "boolean",
        "null"
      ],
      "description": "Whether the trial accepts healthy volunteers. ClinicalTrials.gov trials only."
    },
    "ageGroups": {
      "type": "array",
      "items": {
        "type": "string",
        "enum": [
          "CHILD",
          "ADULT",
          "OLDER_ADULT"
        ]
      },
      "description": "Age groups the trial enrolls: CHILD (under 18), ADULT (18–64), OLDER_ADULT (65 and over)."
    },
    "designAllocation": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "RANDOMIZED",
        "NON_RANDOMIZED",
        "NA",
        null
      ],
      "description": "How participants are assigned to arms: RANDOMIZED, NON_RANDOMIZED, or NA (single-arm)."
    },
    "designInterventionModel": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "SINGLE_GROUP",
        "PARALLEL",
        "CROSSOVER",
        "FACTORIAL",
        "SEQUENTIAL",
        null
      ],
      "description": "Study design model describing how participants receive interventions: SINGLE_GROUP, PARALLEL (simultaneous arms), CROSSOVER (participants switch arms), FACTORIAL, or SEQUENTIAL."
    },
    "designPrimaryPurpose": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "TREATMENT",
        "PREVENTION",
        "DIAGNOSTIC",
        "ECT",
        "SUPPORTIVE_CARE",
        "SCREENING",
        "HEALTH_SERVICES_RESEARCH",
        "BASIC_SCIENCE",
        "DEVICE_FEASIBILITY",
        "OTHER",
        null
      ],
      "description": "The main objective of the intervention (e.g., TREATMENT, PREVENTION, DIAGNOSTIC)."
    },
    "designMasking": {
      "type": [
        "string",
        "null"
      ],
      "enum": [
        "NONE",
        "SINGLE",
        "DOUBLE",
        "TRIPLE",
        "QUADRUPLE",
        null
      ],
      "description": "Level of blinding: NONE (open-label), SINGLE (one party blinded), DOUBLE, TRIPLE, or QUADRUPLE (participant, care provider, investigator, and outcomes assessor all blinded)."
    },
    "resultsFirstPostDate": {
      "type": [
        "string",
        "null"
      ],
      "format": "date",
      "description": "Date results were first posted on the study's source registry."
    },
    "whyStopped": {
      "type": [
        "string",
        "null"
      ],
      "description": "Reason the study was stopped early, if applicable (e.g., safety concerns, futility, enrollment issues)."
    },
    "isFdaRegulatedDrug": {
      "type": [
        "boolean",
        "null"
      ],
      "description": "Whether the study involves a drug product regulated by the US FDA."
    },
    "isFdaRegulatedDevice": {
      "type": [
        "boolean",
        "null"
      ],
      "description": "Whether the study involves a device product regulated by the US FDA."
    },
    "armGroups": {
      "type": "array",
      "items": {
        "$ref": "#/$defs/TrialCoreArmGroup"
      },
      "description": "Study arms or groups — each arm describes a set of participants receiving a specific intervention or comparator."
    },
    "oversightHasDmc": {
      "type": [
        "boolean",
        "null"
      ],
      "description": "Whether the study has an independent Data Monitoring Committee (DMC) overseeing participant safety."
    },
    "detailedDescription": {
      "type": [
        "string",
        "null"
      ]
    },
    "eligibilityCriteria": {
      "type": [
        "string",
        "null"
      ],
      "description": "The inclusion and exclusion criteria as registered, in plain text with line breaks. Included with ?include=eligibilityCriteria."
    },
    "referencesBiomedCore": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "Cross-core link to BioMedCore: Amass IDs of BioMedCore records (publications) referenced by this trial, linking trials to their associated literature. Ordered results-first. A paper whose own PubMed record registers this trial's id is reporting that trial, so it comes before the background literature the sponsor also filed."
    },
    "referencesDrugCore": {
      "type": "array",
      "items": {
        "type": "string"
      },
      "description": "Cross-core link to DrugCore: Amass IDs of DrugCore records (drugs) studied by this trial, linking trials to the drugs they evaluate. Included with ?include=referencesDrugCore."
    },
    "outcomes": {
      "type": "array",
      "items": {
        "$ref": "#/$defs/TrialCoreOutcome"
      },
      "description": "Posted trial results including outcome measurements, statistical parameters, and per-arm data."
    }
  },
  "required": [
    "amassId",
    "nctId",
    "registryId",
    "sourceRegistry",
    "sourceUrl",
    "url",
    "briefTitle",
    "officialTitle",
    "briefSummary",
    "acronym",
    "phase",
    "overallStatus",
    "lastKnownStatus",
    "studyType",
    "startDate",
    "primaryCompletionDate",
    "completionDate",
    "lastUpdateDate",
    "createDate",
    "hasResults",
    "enrollment",
    "enrollmentType",
    "sponsorName",
    "sponsorType",
    "collaborators",
    "conditions",
    "conditionMeshTerms",
    "interventionTypes",
    "interventionNames",
    "interventionMeshTerms",
    "facilityCountries",
    "keywords",
    "orgStudyId",
    "secondaryIds",
    "primaryOutcomeMeasures",
    "secondaryOutcomeMeasures",
    "minAgeYears",
    "maxAgeYears",
    "sex",
    "healthyVolunteers",
    "ageGroups",
    "designAllocation",
    "designInterventionModel",
    "designPrimaryPurpose",
    "designMasking",
    "resultsFirstPostDate",
    "whyStopped",
    "isFdaRegulatedDrug",
    "isFdaRegulatedDevice",
    "armGroups",
    "oversightHasDmc"
  ],
  "$defs": {
    "TrialCoreArmGroup": {
      "type": "object",
      "properties": {
        "type": {
          "type": [
            "string",
            "null"
          ],
          "enum": [
            "EXPERIMENTAL",
            "ACTIVE_COMPARATOR",
            "PLACEBO_COMPARATOR",
            "SHAM_COMPARATOR",
            "NO_INTERVENTION",
            "OTHER",
            null
          ],
          "description": "Role of this arm in the study (e.g., EXPERIMENTAL, PLACEBO_COMPARATOR, ACTIVE_COMPARATOR, NO_INTERVENTION)."
        },
        "title": {
          "type": [
            "string",
            "null"
          ],
          "description": "Label for this arm (e.g., \"Drug A 10mg\", \"Placebo\")."
        },
        "description": {
          "type": [
            "string",
            "null"
          ],
          "description": "Brief description of the intervention or comparator used in this arm."
        }
      },
      "required": [
        "type",
        "title",
        "description"
      ]
    },
    "TrialCoreOutcome": {
      "type": "object",
      "properties": {
        "outcomeType": {
          "type": [
            "string",
            "null"
          ],
          "enum": [
            "PRIMARY",
            "SECONDARY",
            "OTHER_PRE_SPECIFIED",
            "POST_HOC",
            null
          ],
          "description": "Whether this is a PRIMARY, SECONDARY, OTHER_PRE_SPECIFIED, or POST_HOC outcome."
        },
        "title": {
          "type": [
            "string",
            "null"
          ],
          "description": "Name of the outcome measure (e.g., \"Overall Survival\", \"Change in HbA1c\")."
        },
        "description": {
          "type": [
            "string",
            "null"
          ],
          "description": "Detailed definition of how the outcome was measured."
        },
        "timeFrame": {
          "type": [
            "string",
            "null"
          ],
          "description": "Time period over which the outcome was assessed (e.g., \"Baseline to 12 weeks\")."
        },
        "population": {
          "type": [
            "string",
            "null"
          ],
          "description": "Description of the analysis population (e.g., \"Intent-to-treat\", \"Per-protocol\")."
        },
        "units": {
          "type": [
            "string",
            "null"
          ],
          "description": "Unit of measurement for the reported values (e.g., \"Participants\", \"mg/dL\", \"Percentage of Participants\")."
        },
        "paramType": {
          "type": [
            "string",
            "null"
          ],
          "enum": [
            "GEOMETRIC_MEAN",
            "GEOMETRIC_LEAST_SQUARES_MEAN",
            "LEAST_SQUARES_MEAN",
            "LOG_MEAN",
            "MEAN",
            "MEDIAN",
            "NUMBER",
            "COUNT_OF_PARTICIPANTS",
            "COUNT_OF_UNITS",
            null
          ],
          "description": "Statistical parameter type used for paramValue in measurements (e.g., MEAN, MEDIAN, COUNT_OF_PARTICIPANTS)."
        },
        "dispersionType": {
          "type": [
            "string",
            "null"
          ],
          "enum": [
            "NA",
            "STANDARD_DEVIATION",
            "STANDARD_ERROR",
            "INTER_QUARTILE_RANGE",
            "FULL_RANGE",
            "CONFIDENCE_80",
            "CONFIDENCE_90",
            "CONFIDENCE_95",
            "CONFIDENCE_975",
            "CONFIDENCE_99",
            "CONFIDENCE_OTHER",
            "GEOMETRIC_COEFFICIENT",
            null
          ],
          "description": "Type of variability measure used for dispersion values in measurements (e.g., STANDARD_DEVIATION, CONFIDENCE_95, FULL_RANGE)."
        },
        "measurements": {
          "type": "array",
          "items": {
            "$ref": "#/$defs/TrialCoreOutcomeMeasurement"
          },
          "description": "Per-arm measurement data for this outcome."
        }
      },
      "required": [
        "outcomeType",
        "title",
        "description",
        "timeFrame",
        "population",
        "units",
        "paramType",
        "dispersionType",
        "measurements"
      ]
    },
    "TrialCoreOutcomeMeasurement": {
      "type": "object",
      "properties": {
        "group": {
          "type": [
            "string",
            "null"
          ],
          "description": "Display name of the arm or group this measurement belongs to."
        },
        "groupId": {
          "type": [
            "string",
            "null"
          ],
          "description": "ClinicalTrials.gov internal group identifier (e.g., OG000)."
        },
        "classification": {
          "type": [
            "string",
            "null"
          ],
          "description": "Row-level classification when results are broken down by subgroup (e.g., age range, body site)."
        },
        "category": {
          "type": [
            "string",
            "null"
          ],
          "description": "Sub-category within a classification (e.g., a specific age bracket)."
        },
        "paramValue": {
          "type": [
            "string",
            "null"
          ],
          "description": "The measured value for this outcome (interpretation depends on the parent outcome's paramType)."
        },
        "dispersionValue": {
          "type": [
            "string",
            "null"
          ],
          "description": "Dispersion or variability value (interpretation depends on the parent outcome's dispersionType)."
        },
        "dispersionLowerLimit": {
          "type": [
            "string",
            "null"
          ],
          "description": "Lower bound of the dispersion range (e.g., lower end of a confidence interval)."
        },
        "dispersionUpperLimit": {
          "type": [
            "string",
            "null"
          ],
          "description": "Upper bound of the dispersion range (e.g., upper end of a confidence interval)."
        }
      }
    }
  }
}