CIMAC-CIDC/cidc-schemas

{
  "$schema": "metaschema/strict_meta_schema.json#",
  "$id": "clinical_trial",
  "title": "Clinical Trial",

    "$comment": "description used in docs/index.html and docs/clinical_trial.html",
  "description": "Encapsulates information regarding a clinical trial.",
  
  "additionalProperties": false,
  "type": "object",
  "properties": {
    "nct_id": {
      "type": "string",
      "description": "ClinicalTrials.gov identifier. Example: NCT03731260."
    },
    "nci_id": {
      "type": "string",
      "description": "NCI Trial Identifier. Example: NCI22345."
    },
    "protocol_identifier": {
      "type": "string",
      "description": "Trial identifier used by lead organization, ie. Center for Experimental Therapeutics Program (CTEP) ID or Industry Sponsored ID.  This is usually a short identifier. Example: E4412."
    },
    "trial_name": {
      "description": "Name of clinical trial.",
      "type": "string"
    },
    "trial_description": {
      "description": "A brief description of the clinical trial.",
      "type": "string"
    },
    "trial_organization": {
      "description": "Name of the primary organization that oversees the clinical trial. Example: ECOG-ACRIN, SWOG, etc.",
      "type": "string"
    },
    "grant_or_affiliated_network": {
      "description": "The primary organization providing grant funding and supporting the trial.",
      "type": "string"
    },
    "trial_status": {
      "description": "What stage the clinical trial is at in its process.",
      "type": "string",
      "enum": ["New", "Ongoing", "Completed"]
    },
    "biobank": {
      "description": "The primary organization responsible for storing biospecimens from this study.",
      "type": "string"
    },
    "lead_cimac_pis": {
      "description": "The PI(s) from the CIMAC-CIDC network responsible for this study.",
      "type": "array",
      "items": { "type": "string" }
    },
    "lead_cimac_contacts": {
      "description": "A list of contacts for this trial.",
      "type": "array",
      "items": { "type": "string" }
    },
    "lead_trial_staff": {
      "description": "The names of lead trial staff members other than the PIs.",
      "type": "array",
      "items": { "type": "string" }
    },
    "justification": {
      "description": "A description of the reasons why this study could provide insight into molecular biomarkers of immunotherapy.",
      "type": "string"
    },
    "schema": {
      "$ref": "artifacts/artifact_image.json",
      "description": "An image of trial schema, if available"
    },
    "biomarker_plan": {
      "description": "A description of the objectives and hypotheses for the proposed biomarkers.",
      "type": "string"
    },
    "data_sharing_plan": {
      "description": "A description of the rules governing data sharing and publications.",
      "type": "string"
    },
    "expected_assays": {
      "type": "array",
      "items": { "type": "string" },
      "description": "A list of assays the CIDC expects to receive for this trial."
    },
    "allowed_collection_event_names": {
      "description": "Allowed values for sample.json#properties/collection_event_name for this trial.",
      "type": "array",
      "$comment": "This works together with sample.json#properties/collection_event_name/in_doc_ref_pattern.",
      "items": {
        "type": "string"
      }
    },
    "allowed_cohort_names": {
      "description": "Allowed values for sample.json#properties/cohort_name for this trial.",
      "type": "array",
      "$comment": "This works together with sample.json#properties/cohort_name/in_doc_ref_pattern.",
      "items": {
        "type": "string"
      }
    },
    "shipments": {
      "type": "array",
      "items": {
        "$ref": "shipping_core.json"
      },
      "mergeStrategy": "append",
      "description": "Core shipping details for a manifest"
    },
    "participants": {
      "type": "array",
      "description": "The collection of all data related to a specific participant in the context of a specific clinical trial.",
      "items": {
        "$ref": "participant.json"
      },
      "mergeStrategy": "arrayMergeById",
      "mergeOptions": {
        "idRef": "/cimac_participant_id"
      }
    },
    "assays": {
      "$comment": "Assays for this trial",
      "$ref": "assays/components/available_assays.json"
    },
    "analysis": {
      "$ref": "assays/components/available_ngs_analyses.json"
    },
    "clinical_data": {
      "$ref": "clinical_data.json"
    }
  },
  "required": [
    "protocol_identifier",
    "participants",
    "allowed_cohort_names",
    "allowed_collection_event_names"
  ]
}