FHIR IG analytics| Package | hl7.fhir.uv.src-ig |
| Resource Type | CodeSystem |
| Id | CodeSystem-ctd-categories-full.json |
| FHIR Version | R5 |
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Note: links and images are rebased to the (stated) source
Generated Narrative: CodeSystem ctd-categories-full
This case-sensitive code system http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full defines the following codes in a Is-A hierarchy:
FHIR
FHIRsmith{
"resourceType": "CodeSystem",
"id": "ctd-categories-full",
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"url": "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"version": "0.1.0",
"name": "CTDQuestionCategoriesFull",
"title": "CTD-Based Regulatory Question Categories (Full Granularity)",
"status": "draft",
"experimental": true,
"date": "2025-11-11",
"publisher": "Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)",
"contact": [
{
"name": "Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)",
"telecom": [
{
"system": "url",
"value": "https://www.gravitatehealth.eu/"
}
]
}
],
"description": "Hierarchical terminology derived from ICH CTD Modules 2-5 for classifying regulator-to-sponsor questions in Structured Regulatory Correspondence (SRC). Supports multi-level granularity for EMA, FDA, and Health Canada harmonization.",
"caseSensitive": true,
"valueSet": "http://hl7.org/fhir/uv/src-ig/ValueSet/vs-ctd-question-categories-full",
"hierarchyMeaning": "is-a",
"content": "complete",
"concept": [
{
"code": "summaries",
"display": "CTD Summaries",
"definition": "Module 2 – CTD Summaries",
"concept": [
{
"code": "summaries.quality",
"display": "Quality Overall Summary",
"definition": "2.3 Quality Overall Summary",
"concept": [
{
"code": "summaries.quality.intro",
"display": "Introduction",
"definition": "2.3.S/P Introduction"
},
{
"code": "summaries.quality.body",
"display": "Body of Data",
"definition": "2.3.S/P Body of Data"
},
{
"code": "summaries.quality.literature",
"display": "Literature References",
"definition": "2.3.S/P Literature References"
}
]
},
{
"code": "summaries.nonclinical",
"display": "Nonclinical Overview",
"definition": "2.4 Nonclinical Overview",
"concept": [
{
"code": "summaries.nonclinical.pharmacology",
"display": "Pharmacology",
"definition": "2.4.1-2 Pharmacology"
},
{
"code": "summaries.nonclinical.pk",
"display": "Pharmacokinetics",
"definition": "2.4.3 Pharmacokinetics"
},
{
"code": "summaries.nonclinical.tox",
"display": "Toxicology",
"definition": "2.4.4-6 Toxicology"
}
]
},
{
"code": "summaries.clinical",
"display": "Clinical Overview",
"definition": "2.5 Clinical Overview",
"concept": [
{
"code": "summaries.clinical.efficacy",
"display": "Efficacy",
"definition": "2.5.2 Efficacy"
},
{
"code": "summaries.clinical.safety",
"display": "Safety",
"definition": "2.5.3 Safety"
},
{
"code": "summaries.clinical.brm",
"display": "Benefit-Risk Assessment",
"definition": "2.5.4 Benefit-Risk"
}
]
},
{
"code": "summaries.synopses",
"display": "Synopses of Individual Studies",
"definition": "2.7 Synopses of Individual Studies"
}
]
},
{
"code": "quality",
"display": "Quality (CMC)",
"definition": "Module 3 – Quality",
"concept": [
{
"code": "quality.drug-substance",
"display": "Drug Substance",
"definition": "3.2.S Drug Substance",
"concept": [
{
"code": "quality.drug-substance.general",
"display": "General Information",
"definition": "3.2.S.1 General Information",
"concept": [
{
"code": "quality.drug-substance.general.nomenclature",
"display": "Nomenclature",
"definition": "3.2.S.1.1 Nomenclature"
},
{
"code": "quality.drug-substance.general.structure",
"display": "Structure",
"definition": "3.2.S.1.2 Structure"
},
{
"code": "quality.drug-substance.general.properties",
"display": "General Properties",
"definition": "3.2.S.1.3 General Properties"
}
]
},
{
"code": "quality.drug-substance.manufacture",
"display": "Manufacture",
"definition": "3.2.S.2 Manufacture",
"concept": [
{
"code": "quality.drug-substance.manufacture.manufacturer",
"display": "Manufacturer",
"definition": "3.2.S.2.1 Manufacturer"
},
{
"code": "quality.drug-substance.manufacture.description",
"display": "Description of Manufacturing Process and Process Controls",
"definition": "3.2.S.2.2 Description of Manufacturing Process"
},
{
"code": "quality.drug-substance.manufacture.controls",
"display": "Control of Materials",
"definition": "3.2.S.2.3 Control of Materials"
},
{
"code": "quality.drug-substance.manufacture.critical-steps",
"display": "Controls of Critical Steps and Intermediates",
"definition": "3.2.S.2.4 Controls of Critical Steps and Intermediates"
},
{
"code": "quality.drug-substance.manufacture.validation",
"display": "Process Validation and/or Evaluation",
"definition": "3.2.S.2.5 Process Validation"
},
{
"code": "quality.drug-substance.manufacture.development",
"display": "Manufacturing Process Development",
"definition": "3.2.S.2.6 Manufacturing Process Development"
}
]
},
{
"code": "quality.drug-substance.characterisation",
"display": "Characterisation",
"definition": "3.2.S.3 Characterisation",
"concept": [
{
"code": "quality.drug-substance.characterisation.elucidation",
"display": "Elucidation of Structure and Other Characteristics",
"definition": "3.2.S.3.1 Elucidation of Structure"
},
{
"code": "quality.drug-substance.characterisation.impurities",
"display": "Impurities",
"definition": "3.2.S.3.2 Impurities"
}
]
},
{
"code": "quality.drug-substance.control",
"display": "Control of Drug Substance",
"definition": "3.2.S.4 Control of Drug Substance",
"concept": [
{
"code": "quality.drug-substance.control.specification",
"display": "Specification",
"definition": "3.2.S.4.1 Specification"
},
{
"code": "quality.drug-substance.control.analytical",
"display": "Analytical Procedures",
"definition": "3.2.S.4.2 Analytical Procedures"
},
{
"code": "quality.drug-substance.control.validation",
"display": "Validation of Analytical Procedures",
"definition": "3.2.S.4.3 Validation of Analytical Procedures"
},
{
"code": "quality.drug-substance.control.batch",
"display": "Batch Analyses",
"definition": "3.2.S.4.4 Batch Analyses"
},
{
"code": "quality.drug-substance.control.justification",
"display": "Justification of Specification",
"definition": "3.2.S.4.5 Justification of Specification"
}
]
},
{
"code": "quality.drug-substance.reference",
"display": "Reference Standards or Materials",
"definition": "3.2.S.5 Reference Standards"
},
{
"code": "quality.drug-substance.container",
"display": "Container Closure System",
"definition": "3.2.S.6 Container Closure System"
},
{
"code": "quality.drug-substance.stability",
"display": "Stability",
"definition": "3.2.S.7 Stability",
"concept": [
{
"code": "quality.drug-substance.stability.summary",
"display": "Stability Summary and Conclusions",
"definition": "3.2.S.7.1 Stability Summary"
},
{
"code": "quality.drug-substance.stability.protocol",
"display": "Post-approval Stability Protocol and Commitment",
"definition": "3.2.S.7.2 Post-approval Protocol"
},
{
"code": "quality.drug-substance.stability.data",
"display": "Stability Data",
"definition": "3.2.S.7.3 Stability Data"
}
]
}
]
},
{
"code": "quality.drug-product",
"display": "Drug Product",
"definition": "3.2.P Drug Product",
"concept": [
{
"code": "quality.drug-product.description",
"display": "Description and Composition of the Drug Product",
"definition": "3.2.P.1 Description and Composition"
},
{
"code": "quality.drug-product.pharmaceutical-development",
"display": "Pharmaceutical Development",
"definition": "3.2.P.2 Pharmaceutical Development",
"concept": [
{
"code": "quality.drug-product.pharmaceutical-development.components",
"display": "Components of the Drug Product",
"definition": "3.2.P.2.1 Components"
},
{
"code": "quality.drug-product.pharmaceutical-development.drug-product",
"display": "Drug Product",
"definition": "3.2.P.2.2 Drug Product"
},
{
"code": "quality.drug-product.pharmaceutical-development.manufacturing",
"display": "Manufacturing Process Development",
"definition": "3.2.P.2.3 Manufacturing Process Development"
},
{
"code": "quality.drug-product.pharmaceutical-development.container",
"display": "Container Closure System",
"definition": "3.2.P.2.4 Container Closure System"
},
{
"code": "quality.drug-product.pharmaceutical-development.microbiological",
"display": "Microbiological Attributes",
"definition": "3.2.P.2.5 Microbiological Attributes"
},
{
"code": "quality.drug-product.pharmaceutical-development.compatibility",
"display": "Compatibility",
"definition": "3.2.P.2.6 Compatibility"
}
]
},
{
"code": "quality.drug-product.manufacture",
"display": "Manufacture",
"definition": "3.2.P.3 Manufacture",
"concept": [
{
"code": "quality.drug-product.manufacture.manufacturer",
"display": "Manufacturer(s)",
"definition": "3.2.P.3.1 Manufacturer(s)"
},
{
"code": "quality.drug-product.manufacture.batch",
"display": "Batch Formula",
"definition": "3.2.P.3.2 Batch Formula"
},
{
"code": "quality.drug-product.manufacture.process",
"display": "Description of Manufacturing Process and Process Controls",
"definition": "3.2.P.3.3 Description of Manufacturing Process"
},
{
"code": "quality.drug-product.manufacture.controls",
"display": "Controls of Critical Steps and Intermediates",
"definition": "3.2.P.3.4 Controls of Critical Steps"
},
{
"code": "quality.drug-product.manufacture.validation",
"display": "Process Validation and/or Evaluation",
"definition": "3.2.P.3.5 Process Validation"
}
]
},
{
"code": "quality.drug-product.excipients",
"display": "Control of Excipients",
"definition": "3.2.P.4 Control of Excipients",
"concept": [
{
"code": "quality.drug-product.excipients.specifications",
"display": "Specifications",
"definition": "3.2.P.4.1 Specifications"
},
{
"code": "quality.drug-product.excipients.analytical",
"display": "Analytical Procedures",
"definition": "3.2.P.4.2 Analytical Procedures"
},
{
"code": "quality.drug-product.excipients.validation",
"display": "Validation of Analytical Procedures",
"definition": "3.2.P.4.3 Validation"
},
{
"code": "quality.drug-product.excipients.justification",
"display": "Justification of Specifications",
"definition": "3.2.P.4.4 Justification"
},
{
"code": "quality.drug-product.excipients.novel",
"display": "Novel Excipients",
"definition": "3.2.P.4.5 Novel Excipients"
}
]
},
{
"code": "quality.drug-product.control",
"display": "Control of Drug Product",
"definition": "3.2.P.5 Control of Drug Product",
"concept": [
{
"code": "quality.drug-product.control.specification",
"display": "Specification",
"definition": "3.2.P.5.1 Specification"
},
{
"code": "quality.drug-product.control.analytical",
"display": "Analytical Procedures",
"definition": "3.2.P.5.2 Analytical Procedures"
},
{
"code": "quality.drug-product.control.validation",
"display": "Validation of Analytical Procedures",
"definition": "3.2.P.5.3 Validation"
},
{
"code": "quality.drug-product.control.batch",
"display": "Batch Analyses",
"definition": "3.2.P.5.4 Batch Analyses"
},
{
"code": "quality.drug-product.control.characterisation",
"display": "Characterisation of Impurities",
"definition": "3.2.P.5.5 Characterisation of Impurities"
},
{
"code": "quality.drug-product.control.justification",
"display": "Justification of Specification",
"definition": "3.2.P.5.6 Justification"
}
]
},
{
"code": "quality.drug-product.reference",
"display": "Reference Standards or Materials",
"definition": "3.2.P.6 Reference Standards"
},
{
"code": "quality.drug-product.container",
"display": "Container Closure System",
"definition": "3.2.P.7 Container Closure System"
},
{
"code": "quality.drug-product.stability",
"display": "Stability",
"definition": "3.2.P.8 Stability",
"concept": [
{
"code": "quality.drug-product.stability.summary",
"display": "Stability Summary and Conclusions",
"definition": "3.2.P.8.1 Stability Summary"
},
{
"code": "quality.drug-product.stability.protocol",
"display": "Post-approval Stability Protocol and Commitment",
"definition": "3.2.P.8.2 Post-approval Protocol"
},
{
"code": "quality.drug-product.stability.data",
"display": "Stability Data",
"definition": "3.2.P.8.3 Stability Data"
}
]
}
]
},
{
"code": "quality.appendices",
"display": "Appendices",
"definition": "3.2.A Appendices",
"concept": [
{
"code": "quality.appendices.facilities",
"display": "Facilities and Equipment",
"definition": "3.2.A.1 Facilities and Equipment"
},
{
"code": "quality.appendices.adventitious",
"display": "Adventitious Agents Safety Evaluation",
"definition": "3.2.A.2 Adventitious Agents"
},
{
"code": "quality.appendices.novel-excipients",
"display": "Novel Excipients",
"definition": "3.2.A.3 Novel Excipients"
}
]
},
{
"code": "quality.regional",
"display": "Regional Information",
"definition": "3.3 Regional Information"
}
]
},
{
"code": "nonclinical",
"display": "Nonclinical Study Reports",
"definition": "Module 4 – Nonclinical Study Reports",
"concept": [
{
"code": "nonclinical.pharmacology",
"display": "Pharmacology",
"definition": "4.2 Pharmacology",
"concept": [
{
"code": "nonclinical.pharmacology.primary",
"display": "Primary Pharmacodynamics",
"definition": "4.2.1.1 Primary Pharmacodynamics"
},
{
"code": "nonclinical.pharmacology.secondary",
"display": "Secondary Pharmacodynamics",
"definition": "4.2.1.2 Secondary Pharmacodynamics"
},
{
"code": "nonclinical.pharmacology.safety",
"display": "Safety Pharmacology",
"definition": "4.2.1.3 Safety Pharmacology"
},
{
"code": "nonclinical.pharmacology.discussion",
"display": "Pharmacodynamic Drug Interactions",
"definition": "4.2.1.4 Pharmacodynamic Drug Interactions"
}
]
},
{
"code": "nonclinical.pk",
"display": "Pharmacokinetics",
"definition": "4.2.2 Pharmacokinetics",
"concept": [
{
"code": "nonclinical.pk.absorption",
"display": "Absorption",
"definition": "4.2.2.1 Absorption"
},
{
"code": "nonclinical.pk.distribution",
"display": "Distribution",
"definition": "4.2.2.2 Distribution"
},
{
"code": "nonclinical.pk.metabolism",
"display": "Metabolism",
"definition": "4.2.2.3 Metabolism"
},
{
"code": "nonclinical.pk.excretion",
"display": "Excretion",
"definition": "4.2.2.4 Excretion"
},
{
"code": "nonclinical.pk.interactions",
"display": "PK Drug Interactions",
"definition": "4.2.2.5 PK Drug Interactions"
}
]
},
{
"code": "nonclinical.toxicology",
"display": "Toxicology",
"definition": "4.2.3 Toxicology",
"concept": [
{
"code": "nonclinical.toxicology.single",
"display": "Single-Dose Toxicity",
"definition": "4.2.3.1 Single-Dose Toxicity"
},
{
"code": "nonclinical.toxicology.repeat",
"display": "Repeat-Dose Toxicity",
"definition": "4.2.3.2 Repeat-Dose Toxicity"
},
{
"code": "nonclinical.toxicology.geno",
"display": "Genotoxicity",
"definition": "4.2.3.3 Genotoxicity",
"concept": [
{
"code": "nonclinical.toxicology.geno.invitro",
"display": "In Vitro",
"definition": "4.2.3.3.1 In Vitro"
},
{
"code": "nonclinical.toxicology.geno.invivo",
"display": "In Vivo",
"definition": "4.2.3.3.2 In Vivo"
}
]
},
{
"code": "nonclinical.toxicology.carc",
"display": "Carcinogenicity",
"definition": "4.2.3.4 Carcinogenicity"
},
{
"code": "nonclinical.toxicology.repro",
"display": "Reproductive and Developmental Toxicity",
"definition": "4.2.3.5 Reproductive Toxicity",
"concept": [
{
"code": "nonclinical.toxicology.repro.fertility",
"display": "Fertility and Early Embryonic Development",
"definition": "4.2.3.5.1 Fertility"
},
{
"code": "nonclinical.toxicology.repro.embryo",
"display": "Embryo-Fetal Development",
"definition": "4.2.3.5.2 Embryo-Fetal"
},
{
"code": "nonclinical.toxicology.repro.peri",
"display": "Peri- and Post-Natal Development",
"definition": "4.2.3.5.3 Peri-/Post-Natal"
}
]
},
{
"code": "nonclinical.toxicology.local",
"display": "Local Tolerance",
"definition": "4.2.3.6 Local Tolerance"
},
{
"code": "nonclinical.toxicology.other",
"display": "Other Toxicity Studies",
"definition": "4.2.3.7 Other Toxicity Studies",
"concept": [
{
"code": "nonclinical.toxicology.other.antigenicity",
"display": "Antigenicity",
"definition": "4.2.3.7.1 Antigenicity"
},
{
"code": "nonclinical.toxicology.other.immunotox",
"display": "Immunotoxicity",
"definition": "4.2.3.7.2 Immunotoxicity"
},
{
"code": "nonclinical.toxicology.other.mechanistic",
"display": "Mechanistic Studies",
"definition": "4.2.3.7.3 Mechanistic"
},
{
"code": "nonclinical.toxicology.other.impurities",
"display": "Impurities",
"definition": "4.2.3.7.4 Impurities"
},
{
"code": "nonclinical.toxicology.other.metabolites",
"display": "Metabolites",
"definition": "4.2.3.7.5 Metabolites"
},
{
"code": "nonclinical.toxicology.other.other",
"display": "Other",
"definition": "4.2.3.7.6 Other"
}
]
}
]
}
]
},
{
"code": "clinical",
"display": "Clinical Study Reports",
"definition": "Module 5 – Clinical Study Reports",
"concept": [
{
"code": "clinical.biopharm",
"display": "Biopharmaceutic Studies",
"definition": "5.2 Biopharmaceutic Studies",
"concept": [
{
"code": "clinical.biopharm.ba-be",
"display": "Bioavailability / Bioequivalence",
"definition": "5.2.1-2 BA/BE Studies"
},
{
"code": "clinical.biopharm.invitro",
"display": "In Vitro–In Vivo Correlation",
"definition": "5.2.3 IVIVC"
}
]
},
{
"code": "clinical.pk",
"display": "Clinical Pharmacology Studies",
"definition": "5.3 Clinical Pharmacology",
"concept": [
{
"code": "clinical.pk.healthy",
"display": "Studies in Healthy Subjects",
"definition": "5.3.1 Healthy Subjects"
},
{
"code": "clinical.pk.patient",
"display": "Studies in Target Population",
"definition": "5.3.2 Target Population"
},
{
"code": "clinical.pk.intrinsic",
"display": "Intrinsic Factors",
"definition": "5.3.3 Intrinsic Factors",
"concept": [
{
"code": "clinical.pk.intrinsic.renal",
"display": "Renal Impairment",
"definition": "5.3.3.1 Renal"
},
{
"code": "clinical.pk.intrinsic.hepatic",
"display": "Hepatic Impairment",
"definition": "5.3.3.2 Hepatic"
},
{
"code": "clinical.pk.intrinsic.age",
"display": "Age / Pediatric",
"definition": "5.3.3.3 Age/Pediatric"
}
]
},
{
"code": "clinical.pk.extrinsic",
"display": "Extrinsic Factors",
"definition": "5.3.4 Extrinsic Factors",
"concept": [
{
"code": "clinical.pk.extrinsic.ddi",
"display": "Drug-Drug Interactions",
"definition": "5.3.4.1 DDI"
}
]
},
{
"code": "clinical.pk.pop",
"display": "Population PK",
"definition": "5.3.5 Population PK"
}
]
},
{
"code": "clinical.efficacy",
"display": "Clinical Efficacy & Safety Studies",
"definition": "5.3.5-5.4 Efficacy and Safety",
"concept": [
{
"code": "clinical.efficacy.controlled",
"display": "Controlled Clinical Studies",
"definition": "5.3.5.1 Controlled Studies"
},
{
"code": "clinical.efficacy.uncontrolled",
"display": "Uncontrolled Studies",
"definition": "5.3.5.2 Uncontrolled"
},
{
"code": "clinical.efficacy.other",
"display": "Other Studies",
"definition": "5.3.5.3 Other"
},
{
"code": "clinical.efficacy.analysis",
"display": "Analyses of Efficacy",
"definition": "5.3.5.4 Analyses"
}
]
},
{
"code": "clinical.safety",
"display": "Safety Data",
"definition": "5.3.6 Safety",
"concept": [
{
"code": "clinical.safety.exposure",
"display": "Extent of Exposure",
"definition": "5.3.6.1 Exposure"
},
{
"code": "clinical.safety.ae",
"display": "Adverse Events",
"definition": "5.3.6.2 AEs"
},
{
"code": "clinical.safety.lab",
"display": "Clinical Laboratory",
"definition": "5.3.6.3 Lab"
},
{
"code": "clinical.safety.vital",
"display": "Vital Signs / ECG",
"definition": "5.3.6.4 Vital/ECG"
},
{
"code": "clinical.safety.immuno",
"display": "Immunogenicity",
"definition": "5.3.6.5 Immunogenicity"
}
]
},
{
"code": "clinical.literature",
"display": "Literature References",
"definition": "5.4 Literature References"
},
{
"code": "clinical.synopses",
"display": "Synopses of Individual Studies",
"definition": "5.3.7 Synopses"
}
]
}
]
}