diff --git a/README.md b/README.md index 84401c3..a8d1dff 100644 --- a/README.md +++ b/README.md @@ -1,73 +1,356 @@ # Data Definition Engine -This repository contains an open-source tool for generating CDISC 360i study artifacts from a USDM study design. This -software is being developed as part of the CDISC 360i Program by the Define-XML Generation Project Team. - ![under development](https://img.shields.io/badge/under-development-blue) +![License: MIT](https://img.shields.io/badge/License-MIT-blue.svg) +![License: CC BY 4.0](https://img.shields.io/badge/License-CC_BY_4.0-blue.svg) -## Description -The Data Definition Engine (DDE) is a software tool being created as part of the CDISC 360i Define-XML generation -project. The DDE software populates the Data Definition Specification (DDS) model as JSON to facilitate the generation -of study artifacts, such as Define-XML, ODM CRFs, Dataset-JSON shells, and the Trial Design datasets. +The **Data Definition Engine (DDE)** is an open-source tool that automatically generates CDISC regulatory submission artifacts from a structured clinical trial protocol, the famous **Unified Study Definitions Model (USDM)**. It is developed as part of the [CDISC 360i Program](https://github.com/cdisc-org/360i) by the Define-XML Generation Project Team. -The DDE software will include multiple loaders and generators that use the DDS model. The loaders extract and load -metadata content into the DDS model. The generators use the DDS model to generate the study artifacts such as a -define.xml of ODM-based CRFs. +**USDM** stands for **Unified Study Definitions Model** — a Transcelerate / CDISC standard that represents a clinical trial's complete protocol in a machine-readable JSON format. It captures things like study objectives, arms, visits, eligibility criteria, and assessments in a structured, vendor-neutral way. It's the input to this tool — the "source of truth" for the study. It was co-developed through a formal partnership between CDISC and TransCelerate BioPharma as part of **TransCelerate's Digital Data Flow (DDF)** initiative. -Loaders will include the primary 360i loader that reads the USDM study design content, gets the Biomedical Concepts -referenced in the SOA, retrieves the Dataset Specializations (DSSs), and uses the CDISC Library API to populate the -DDS model. An alternative loader will be created to load the DDS model from an Excel metadata spreadsheet template that -matches the metadata spreadsheets used by many organizations today. +--- -## Contribution +## Table of Contents -We welcome contributions to this project. All contributions to this repository fall under the below licenses. -Please checkout [Contribution](CONTRIBUTING.md) for additional information. All contributions must adhere to the -following [Code of Conduct](CODE_OF_CONDUCT.md). +- [Background](#background) +- [How It Works](#how-it-works) +- [Study Artifacts](#study-artifacts) +- [Prerequisites](#prerequisites) +- [Installation](#installation) +- [Usage](#usage) + - [Step 1 — Run the USDM Loader](#step-1--run-the-usdm-loader) + - [Step 2 — Run the Define-XML Generator](#step-2--run-the-define-xml-generator) + - [Full Pipeline Example](#full-pipeline-example) +- [Project Structure](#project-structure) +- [Key Concepts](#key-concepts) +- [Current Status & Roadmap](#current-status--roadmap) +- [Contributing](#contributing) +- [License](#license) +- [References](#references) -## License +--- -![License: MIT](https://img.shields.io/badge/License-MIT-blue.svg) ![License: CC BY 4.0](https://img.shields.io/badge/License-CC_BY_4.0-blue.svg) +## Background -### Code and Models +Clinical trials submitted to regulatory agencies (such as the FDA) must include standardized metadata files that describe the structure, content, and meaning of all datasets. Producing these files — most notably **Define-XML** — has traditionally been a manual, error-prone, and time-consuming process. -This project is using the [MIT](http://www.opensource.org/licenses/MIT "The MIT License | Open Source Initiative") license (see [`LICENSE`](LICENSE)) for -code and models. +The CDISC 360i program aims to automate this process end-to-end: starting from a machine-readable study protocol (**USDM**), the DDE derives all the metadata needed to generate regulatory submission artifacts. It eliminates the gap between protocol design and data submission by using the same source of truth throughout the study lifecycle. -### Content +--- -The content files, like documentation, are released under [CC-BY-4.0](https://creativecommons.org/licenses/by/4.0/). This does not include trademark permissions. +## How It Works -## Re-use +The DDE implements a three-stage pipeline: -When you re-use the source, keep or copy the license information also in the source code files. When you re-use the -source in proprietary software or distribute binaries (derived or underived), also copy the license text to a -third-party-licenses file or similar. +``` +USDM Study Design JSON + │ + ▼ +┌───────────────────┐ +│ LOADER │ create_define_json.py +│ │ • Reads the USDM protocol +│ │ • Fetches Biomedical Concepts +│ │ • Retrieves Dataset Specializations +│ │ • Calls the CDISC Library API +└────────┬──────────┘ + │ + ▼ DDS JSON (define.json) ◄── central intermediate model + │ +┌────────┴──────────┐ +│ GENERATOR │ define_generator.py +│ │ • Reads the DDS JSON +│ │ • Builds Define-XML v2.1 elements +│ │ • Writes the output XML +└────────┬──────────┘ + │ + ▼ + Define-XML v2.1 (.xml) + HTML rendering (.html) +``` -When you want to re-use and refer to the content, please do so like the following: +**Loaders** extract metadata from various sources and populate the central **Data Definition Specification (DDS)** model (a JSON file). **Generators** consume that DDS JSON and produce the final submission artifacts. -> Content based on [Data Definition Engine (GitHub)](https://github.com/cdisc-org/data-definition-engine) used under the [CC-BY-4.0](https://creativecommons.org/licenses/by/4.0/) license. +> **Why a central JSON model?** +> No single source has all the metadata needed for a full submission. The DDS acts as an aggregation layer, combining protocol content, biomedical concept definitions, controlled terminology, and any manually filled gaps into one validated model. + +--- + +## Study Artifacts + +| Artifact | Format | Description | Status | +|---|---|---|---| +| SDTM Define-XML | `.xml` | Metadata file describing SDTM dataset structure, variables, and controlled terminology for FDA submission | ✅ Implemented | +| ADaM Define-XML | `.xml` | Same for Analysis Datasets (ADaM) | 🔜 Planned | +| ODM CRFs | `.xml` | Case Report Form definitions in ODM format for data collection | 🔜 Planned | +| Trial Design Datasets | `.json` | TA, TD, TE, TI, TM, TS, TV datasets describing study design | 🔜 Planned | +| Dataset-JSON shells | `.json` | Empty dataset templates in Dataset-JSON format | 🔜 Planned | + +--- + +## Prerequisites + +- **Python 3.8+** +- A **CDISC Library API key** — required to fetch Biomedical Concepts and Dataset Specializations during loading. Request one at [CDISC Library](https://library.cdisc.org/). +- Git (to clone the repository) + +--- + +## Installation + +```bash +# Clone the repository +git clone https://github.com/cdisc-org/data-definition-engine.git +cd data-definition-engine + +# Install loader dependencies +pip install -r src/define-xml/requirements.txt + +# Install generator dependencies +pip install -r src/generators/define/requirements.txt +``` + +**Set your CDISC Library API key** — create a `.env` file in `src/define-xml/`: + +```bash +# src/define-xml/.env +CDISC_API_KEY=your_api_key_here +``` + +Or pass it directly on the command line with `--cdisc_api_key`. + +--- + +## Usage + +### Step 1 — Run the USDM Loader + +The loader reads a USDM protocol JSON file, enriches it with metadata from the CDISC Library, and writes a DDS JSON file. + +> **Windows (PowerShell):** use a backtick `` ` `` for line continuation instead of `\`. + +```bash +# bash / macOS / Linux +cd src/define-xml + +python create_define_json.py \ + --usdm_file ../../data/protocol/LZZT/usdm/pilot_LLZT_protocol.json \ + --output_template ./output/define.json \ + --sdtmct 2024-09-27 +``` + +```powershell +# Windows PowerShell +cd src/define-xml + +python create_define_json.py ` + --usdm_file ..\..\data\protocol\LZZT\usdm\pilot_LLZT_protocol.json ` + --output_template .\output\define.json ` + --sdtmct 2024-09-27 +``` + +**All arguments:** + +| Argument | Required | Default | Description | +|---|---|---|---| +| `--usdm_file` | Yes | — | Path to the USDM input JSON file | +| `--output_template` | Yes | — | Path for the output DDS JSON file | +| `--sdtmct` | Yes | — | SDTM Controlled Terminology date (`yyyy-mm-dd`) | +| `--sdtmig` | No | `3.4` | SDTM Implementation Guide version | +| `--studyversion` | No | `0` | Study version index in the USDM file (0-based) | +| `--studydesign` | No | `0` | Study design index (0-based) | +| `--docversion` | No | `0` | Document version index (0-based) | +| `--cdisc_api_key` | No | env var | CDISC Library API key (falls back to `CDISC_API_KEY`) | +| `--cosmosversion` | No | `v2` | CDISC Cosmos API version | +| `--validate` | No | — | Validate output against a LinkML YAML schema (uses `define.yaml` if no path given) | +| `--validation_report` | No | — | Path to write an Excel validation report (required with `--validate`) | +| `--patch_file` | No | — | Generate a YAML patch file listing all placeholder/null fields | +| `--apply_patch` | No | — | Apply a completed patch file to fill in placeholder values | +| `--debug` | No | `False` | Save intermediate dictionaries as JSON files for inspection | +| `--cacert` | No | — | Path to a CA bundle (`.pem`) for SSL verification — use when behind a corporate proxy | +| `--no_ssl_verify` | No | `False` | Disable SSL certificate verification (use only in trusted environments) | + +**Tip:** On the first run, use `--patch_file gaps.yaml` to generate a list of all fields that could not be derived automatically. Fill in the values, then re-run with `--apply_patch gaps.yaml`. + +--- + +### Step 2 — Run the Define-XML Generator + +The generator reads the DDS JSON file and produces a Define-XML v2.1 file. + +```bash +# bash / macOS / Linux +cd src/generators/define + +python define_generator.py \ + --template ../../define-xml/output/define.json \ + --define ./output/define.xml +``` + +```powershell +# Windows PowerShell +cd src\generators\define + +python define_generator.py ` + --template ..\..\define-xml\output\define.json ` + --define .\output\define.xml +``` + +**All arguments:** -## Limitations -This project is under active development, so there may be some rough edges, and you should expect changes. We are -entering Phase 2 of the CDISC 360i Program, so there will be some exploratory work to come as we learn more about the -new models used to generate an ADaM define.xml, for example. +| Argument | Short | Required | Default | Description | +|---|---|---|---|---| +| `--template` | `-t` | Yes | — | Path to the DDS JSON input file | +| `--define` | `-d` | No | (built-in default) | Path for the output Define-XML `.xml` file | +| `--validate` | `-s` | No | `False` | Schema-validate the generated XML after writing | +| `--log-level` | `-l` | No | `INFO` | Logging level: `DEBUG`, `INFO`, `WARNING`, `ERROR`, `CRITICAL` | -This project is provided "as is" without any warranty or guarantee of suitability for any particular purpose. +Processing is logged to `define_generator.log`. + +--- + +### Full Pipeline Example + +```bash +# bash / macOS / Linux — from the repository root + +# 1. Load: USDM → DDS JSON +cd src/define-xml +python create_define_json.py \ + --usdm_file ../../data/protocol/LZZT/usdm/pilot_LLZT_protocol.json \ + --output_template ../../output/define.json \ + --sdtmct 2024-09-27 \ + --validate \ + --validation_report ../../output/validation_report.xlsx + +# 2. Generate: DDS JSON → Define-XML +cd ../generators/define +python define_generator.py \ + --template ../../output/define.json \ + --define ../../output/define.xml \ + --validate +``` + +```powershell +# Windows PowerShell — from the repository root + +# 1. Load: USDM → DDS JSON +cd src\define-xml +python create_define_json.py ` + --usdm_file ..\..\data\protocol\LZZT\usdm\pilot_LLZT_protocol.json ` + --output_template ..\..\output\define.json ` + --sdtmct 2024-09-27 ` + --validate ` + --validation_report ..\..\output\validation_report.xlsx + +# 2. Generate: DDS JSON → Define-XML +cd ..\generators\define +python define_generator.py ` + --template ..\..\output\define.json ` + --define ..\..\output\define.xml ` + --validate +``` + +The resulting `output/define.xml` is your SDTM Define-XML v2.1 submission file. +To render it as HTML for human review, apply the bundled XSL stylesheet: + +```bash +# Using xsltproc (Linux/macOS) or Saxon (Windows) +xsltproc src/generators/define/define2-1.xsl output/define.xml > output/define.html +``` + +--- + +## Project Structure + +``` +data-definition-engine/ +│ +├── data/ # Sample study data for development and testing +│ ├── protocol/LZZT/usdm/ # CDISC pilot study LZZT in USDM format +│ └── metadata_xlsx/LZZT/ # SDTM and ADaM metadata spreadsheets (LZZT) +│ +├── documents/ +│ ├── Solution_Overview.md # Architecture design document +│ └── glossary.md # Definitions of key terms +│ +├── HowTos/ # Guides and GIF walkthroughs +│ +└── src/ + ├── define-xml/ # LOADER: USDM → DDS JSON + │ ├── create_define_json.py # Main loader script + │ ├── define.yaml # LinkML schema for the DDS model + │ └── requirements.txt + │ + └── generators/ + └── define/ # GENERATOR: DDS JSON → Define-XML + ├── define_generator.py + ├── define2-1.xsl # XSL stylesheet for HTML rendering + ├── requirements.txt + └── tests/ + └── fixtures/ # Sample DDS JSON and expected XML/HTML outputs +``` + +--- + +## Key Concepts + +| Term | Definition | +|---|---| +| **USDM** (Unified Study Definitions Model) | A TransCelerate / CDISC standard that represents a complete clinical trial protocol as structured, machine-readable JSON. It is the primary input to the DDE. | +| **CDISC 360i** | A CDISC initiative to make the full clinical trial lifecycle — from protocol to submission — machine-readable and interoperable. | +| **DDS** (Data Definition Specification) | The central intermediate JSON model in the DDE pipeline. It aggregates metadata from all sources and acts as the single input for all generators. | +| **Define-XML** | An XML file submitted alongside clinical trial datasets that describes their structure, variables, permitted values, and controlled terminology. Required by the FDA. It is based on the ODM version 2.0 | +| **Biomedical Concepts (BCs)** | Standardized, reusable definitions of clinical observations (e.g., "Heart Rate") maintained in the CDISC Library. | +| **Dataset Specializations (DSSs)** | CDISC Library mappings that describe how a Biomedical Concept is represented in a specific SDTM domain. | +| **CDISC Library** | CDISC's REST API providing access to controlled terminology, SDTM variables, Biomedical Concepts, and Dataset Specializations. | +| **odmlib** | A Python library for creating and parsing CDISC ODM and Define-XML documents, used internally by the generator. | +| **LinkML** | A modeling language used to define and validate the DDS JSON schema (`define.yaml`). | +| **VLM** (Variable Level Metadata) | Metadata that applies to specific values within a variable (e.g., rules that only apply when `VSTEST = "SYSBP"`). | + +--- + +## Current Status & Roadmap + +The project is in **active development**, currently completing Phase 2 of the CDISC 360i Program. + +**Phase 1 (complete):** +- USDM loader (`create_define_json.py`) +- SDTM Define-XML generator (`define_generator.py`) +- DDS JSON schema (`define.yaml`) + +**Phase 2 (in progress):** +- ADaM Define-XML generator +- ODM CRF generator +- Dataset-JSON shell generator +- Incremental loading with metadata provenance tracking +- Quality and conformance checks + +> This project is provided "as is" without warranty or guarantee of suitability for any particular purpose. Expect breaking changes as the new ADaM models and additional generators are developed. + +--- + +## Contributing + +Contributions are welcome. Please read [CONTRIBUTING.md](CONTRIBUTING.md) before submitting pull requests. All contributions must follow the [Code of Conduct](CODE_OF_CONDUCT.md) and will fall under the project licenses below. + +--- + +## License + +### Code and Models +Licensed under the [MIT License](LICENSE). + +### Content (documentation, etc.) +Licensed under [CC-BY-4.0](https://creativecommons.org/licenses/by/4.0/). + +When re-using content, please cite as: +> Content based on [Data Definition Engine (GitHub)](https://github.com/cdisc-org/data-definition-engine) used under the [CC-BY-4.0](https://creativecommons.org/licenses/by/4.0/) license. + +--- ## References -We are in the process of consolidating our project work into this repository. Today, our models and code are spread -across multiple repositories. -- [DDS model (aka define.json)](https://github.com/TeMeta/define-json) -- [DDS documentation site](https://temeta.github.io/define-json/) -- [DDS USDM loader (create_define_json.py)](https://github.com/cdisc-org/360i) -- [Define-XML generator (define_generator.py)](https://github.com/swhume/template2define) -- [CRF generator (cdash_poc_odm132.py, cdash_poc_odm20.py)](https://github.com/lexjansen/cdisc360i-pocs) -- [Phase 1 metadata gaps](https://wiki.cdisc.org/spaces/360i/pages/319525446/360i+Phase+1+Metadata+Gaps) -- [DDS project repository (future)](https://github.com/cdisc-org/DataExchange-DDS) -- [DDS project charter](https://wiki.cdisc.org/display/XMLT/define.json+project+charter) -## Related Projects -Here are some related projects: -- [Data Definition Specification project](https://github.com/cdisc-org/DataExchange-DDS) - [CDISC 360i Program repository](https://github.com/cdisc-org/360i) +- [Data Definition Specification project](https://github.com/cdisc-org/DataExchange-DDS) +- [CRF generator POCs](https://github.com/lexjansen/cdisc360i-pocs) +- [Phase 1 metadata gaps](https://wiki.cdisc.org/spaces/360i/pages/319525446/360i+Phase+1+Metadata+Gaps) diff --git a/src/define-xml/output/define.json b/src/define-xml/output/define.json new file mode 100644 index 0000000..d20f851 --- /dev/null +++ b/src/define-xml/output/define.json @@ -0,0 +1,14828 @@ +{ + "OID": "MDV.LZZT - NEW.Version1.Design1", + "name": "MDV LZZT - NEW", + "description": "Data Definitions for LZZT - NEW", + "fileOID": "ODM.DEFINE-JSON.LZZT - NEW.Version1.Design1", + "creationDateTime": "2026-06-17T15:09:38.032843+00:00", + "odmVersion": "1.3.2", + "fileType": "Snapshot", + "originator": "Define-JSON Processor", + "context": "Other", + "defineVersion": "2.1.0", + "studyOID": "ODM.LZZT - NEW.Version1.Design1", + "studyName": "LZZT - NEW", + "studyDescription": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", + "protocolName": "LZZT - NEW", + "itemGroups": [ + { + "OID": "IG.DS", + "name": "DS", + "description": "Disposition", + "domain": "DS", + "purpose": "Tabulation", + "structure": "One record per disposition status or protocol milestone per subject", + "isReferenceData": false, + "keySequence": [ + "__PLACEHOLDER__" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "EVENTS" + }, + "items": [ + { + "OID": "IT.DS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DS.DSSEQ", + "mandatory": true, + "name": "DSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DS.DSTERM", + "mandatory": true, + "name": "DSTERM", + "description": "Reported Term for the Disposition Event", + "role": "Topic", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.DS.DSDECOD", + "mandatory": true, + "name": "DSDECOD", + "description": "Standardized Disposition Term", + "role": "Synonym Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NCOMPLT" + }, + { + "OID": "IT.DS.DSCAT", + "mandatory": false, + "name": "DSCAT", + "description": "Category for Disposition Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.DSCAT" + }, + { + "OID": "IT.DS.DSSCAT", + "mandatory": false, + "name": "DSSCAT", + "description": "Subcategory for Disposition Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.DSSCAT" + }, + { + "OID": "IT.DS.DSSTDTC", + "mandatory": false, + "name": "DSSTDTC", + "description": "Start Date/Time of Disposition Event", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.DS.DSSTDY", + "mandatory": false, + "name": "DSSTDY", + "description": "Study Day of Start of Disposition Event", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + } + ] + }, + { + "OID": "IG.DM", + "name": "DM", + "description": "Demographics", + "domain": "DM", + "purpose": "Tabulation", + "structure": "One record per subject", + "isReferenceData": false, + "keySequence": [ + "__PLACEHOLDER__" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "SPECIAL-PURPOSE" + }, + "items": [ + { + "OID": "IT.DM.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DM.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DM.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DM.SUBJID", + "mandatory": true, + "name": "SUBJID", + "description": "Subject Identifier for the Study", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DM.RFSTDTC", + "mandatory": false, + "name": "RFSTDTC", + "description": "Subject Reference Start Date/Time", + "role": "Record Qualifier", + "dataType": "datetime", + "origin": { + "type": "__PLACEHOLDER__", + "source": "__PLACEHOLDER__" + } + }, + { + "OID": "IT.DM.RFENDTC", + "mandatory": false, + "name": "RFENDTC", + "description": "Subject Reference End Date/Time", + "role": "Record Qualifier", + "dataType": "datetime", 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"__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NY", + "name": "No Yes Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "N", + "decode": "No", + "coding": { + "code": "C49487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Y", + "decode": "Yes", + "coding": { + "code": "C49488", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.AGEU", + "name": "Age Unit", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66781", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SEX", + "name": "Sex", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66731", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "F", + "decode": "Female", + "coding": { + "code": "C16576", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "M", + "decode": "Male", + "coding": { + "code": "C20197", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.RACE", + "name": "Race", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74457", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ETHNIC", + "name": "Ethnic Group", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66790", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ARMNULRS", + "name": "Arm Null Reason", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C142179", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SCTESTCD", + "name": "Subject Characteristic Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74559", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "EDULEVEL", + "decode": "Level of Education Attained", + "coding": { + "code": "C17953", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EDUYRNUM", + "decode": "Number of Years of Education", + "coding": { + "code": "C122393", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.SCTEST", + "name": "Subject Characteristic Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C103330", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Level of Education Attained", + "decode": "Level of Education Attained", + "coding": { + "code": "C17953", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Number of Years of Education", + "decode": "Number of Years of Education", + "coding": { + "code": "C122393", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.UNIT", + "name": "Unit", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71620", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "CIGAR", + "decode": "Cigar Dosing Unit", + "coding": { + "code": "C116244", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CIGARETTE", + "decode": "Cigarette Dosing Unit", + "coding": { + "code": "C116245", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DRINK", + "decode": "Drink Dosing Unit", + "coding": { + "code": "C161487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "g", + "decode": "Gram", + "coding": { + "code": "C48155", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "GLASS", + "decode": "Glass Dosing Unit", + "coding": { + "code": "C198391", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "L", + "decode": "Liter", + "coding": { + "code": "C48505", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mg", + "decode": "Milligram", + "coding": { + "code": "C28253", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mL", + "decode": "cc", + "coding": { + "code": "C28254", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "oz", + "decode": "Ounce", + "coding": { + "code": "C48519", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PACK", + "decode": "", + "coding": { + "code": "C62653", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PIPE", + "decode": "Pipe Dosing Unit", + "coding": { + "code": "C116246", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ms", + "decode": "Millisecond", + "coding": { + "code": "C41140", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "s", + "decode": "sec", + "coding": { + "code": "C42535", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "g/dL", + "decode": "g%", + "coding": { + "code": "C64783", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "g/L", + "decode": "g/L", + "coding": { + "code": "C42576", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mg/dL", + "decode": "mg%", + "coding": { + "code": "C67015", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "fraction of 1", + "decode": "Proportion of 1", + "coding": { + "code": "C105484", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "10^12/L", + "decode": "/pL", + "coding": { + "code": "C67308", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "fmol", + "decode": "Femtomole", + "coding": { + "code": "C68854", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "pg", + "decode": "Picogram", + "coding": { + "code": "C64551", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mmol/L", + "decode": "mcmol/mL", + "coding": { + "code": "C64387", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "umol/L", + "decode": "nmol/mL", + "coding": { + "code": "C48508", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "10^9/L", + "decode": "/nL", + "coding": { + "code": "C67255", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "10^6/L", + "decode": "/mm3", + "coding": { + "code": "C67452", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "IU/L", + "decode": "IE/L", + "coding": { + "code": "C67376", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "nkat/L", + "decode": "Nanokatal per Liter", + "coding": { + "code": "C70510", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "U/L", + "decode": "mU/mL", + "coding": { + "code": "C67456", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ukat/L", + "decode": "mckat/L", + "coding": { + "code": "C67397", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mg/L", + "decode": "g/m3", + "coding": { + "code": "C64572", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mEq/dL", + "decode": "Milliequivalent per Deciliter", + "coding": { + "code": "C67473", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mEq/L", + "decode": "Milliequivalent Per Liter", + "coding": { + "code": "C67474", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "%", + "decode": "Percentage", + "coding": { + "code": "C25613", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ng/dL", + "decode": "Nanogram per Deciliter", + "coding": { + "code": "C67326", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ng/L", + "decode": "Microgram per Cubic Meter", + "coding": { + "code": "C67327", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "nmol/L", + "decode": "Nanomole per Liter", + "coding": { + "code": "C67432", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ug/L", + "decode": "mcg/L", + "coding": { + "code": "C67306", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ug/dL", + "decode": "Microgram per Deciliter", + "coding": { + "code": "C67305", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mIU/L", + "decode": "mcIU/mL", + "coding": { + "code": "C67405", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mU/L", + "decode": "uU/mL", + "coding": { + "code": "C67408", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "pmol/L", + "decode": "Femtomole per Milliliter", + "coding": { + "code": "C67434", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EU", + "decode": "Ehrlich Units", + "coding": { + "code": "C96599", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "mmol/mol", + "decode": "umol/mmol", + "coding": { + "code": "C111253", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.STENRF", + "name": "Relation to Reference Period", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66728", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NY_Y", + "name": "No Yes Response (Subset Y)", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Y", + "decode": "Yes", + "coding": { + "code": "C49488", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.NY_NY", + "name": "No Yes Response (Subset NY)", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "N", + "decode": "No", + "coding": { + "code": "C49487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Y", + "decode": "Yes", + "coding": { + "code": "C49488", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.FREQ", + "name": "Frequency", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71113", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Q7D", + "decode": "Every 7 Days", + "coding": { + "code": "C139177", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QD", + "decode": "/day", + "coding": { + "code": "C25473", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.PROCEDUR", + "name": "Procedure", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C101858", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LOC", + "name": "Anatomical Location", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74456", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ARM", + "decode": "Arm", + "coding": { + "code": "C32141", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AXILLA", + "decode": "Armpit", + "coding": { + "code": "C12674", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BACK", + "decode": "Back", + "coding": { + "code": "C13062", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BRACHIAL ARTERY", + "decode": "", + "coding": { + "code": "C12681", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BUTTOCK", + "decode": "Buttock", + "coding": { + "code": "C89806", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CAROTID ARTERY", + "decode": "Common Carotid Artery", + "coding": { + "code": "C12687", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CEREBRAL ARTERY", + "decode": "", + "coding": { + "code": "C12691", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHEST", + "decode": "Chest", + "coding": { + "code": "C25389", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DORSALIS PEDIS ARTERY", + "decode": "Dorsal Pedal Artery", + "coding": { + "code": "C32478", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EAR", + "decode": "", + "coding": { + "code": "C12394", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FEMORAL ARTERY", + "decode": "", + "coding": { + "code": "C12715", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FINGER", + "decode": "Finger", + "coding": { + "code": "C32608", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FOREHEAD", + "decode": "Forehead", + "coding": { + "code": "C89803", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ORAL CAVITY", + "decode": "Buccal cavity", + "coding": { + "code": "C12421", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RADIAL ARTERY", + "decode": "Radial Artery", + "coding": { + "code": "C12838", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RECTUM", + "decode": "", + "coding": { + "code": "C12390", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "THIGH", + "decode": "Thigh", + "coding": { + "code": "C33763", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSTESTCD", + "name": "Vital Signs Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66741", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "BMI", + "decode": "Body Mass Index", + "coding": { + "code": "C16358", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DIABP", + "decode": "Diastolic Blood Pressure", + "coding": { + "code": "C25299", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HEIGHT", + "decode": "Height", + "coding": { + "code": "C25347", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HR", + "decode": "Heart Rate", + "coding": { + "code": "C49677", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PULSE", + "decode": "Pulse Rate", + "coding": { + "code": "C49676", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RESP", + "decode": "Respiratory Rate", + "coding": { + "code": "C49678", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SYSBP", + "decode": "Systolic Blood Pressure", + "coding": { + "code": "C25298", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TEMP", + "decode": "Body Temperature", + "coding": { + "code": "C174446", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "WEIGHT", + "decode": "Weight", + "coding": { + "code": "C25208", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSTEST", + "name": "Vital Signs Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67153", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Body Mass Index", + "decode": "Body Mass Index", + "coding": { + "code": "C16358", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Diastolic Blood Pressure", + "decode": "Diastolic Blood Pressure", + "coding": { + "code": "C25299", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Heart Rate", + "decode": "Heart Rate", + "coding": { + "code": "C49677", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Height", + "decode": "Height", + "coding": { + "code": "C25347", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Pulse Rate", + "decode": "Pulse Rate", + "coding": { + "code": "C49676", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Respiratory Rate", + "decode": "Respiratory Rate", + "coding": { + "code": "C49678", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Systolic Blood Pressure", + "decode": "Systolic Blood Pressure", + "coding": { + "code": "C25298", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Temperature", + "decode": "Body Temperature", + "coding": { + "code": "C174446", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Weight", + "decode": "Weight", + "coding": { + "code": "C25208", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.POSITION", + "name": "Position", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71148", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "PRONE", + "decode": "Prone", + "coding": { + "code": "C62165", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SEMI-RECUMBENT", + "decode": "Semi-Supine", + "coding": { + "code": "C111310", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SITTING", + "decode": "Sitting", + "coding": { + "code": "C62122", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "STANDING", + "decode": "Orthostatic", + "coding": { + "code": "C62166", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SUPINE", + "decode": "Supine", + "coding": { + "code": "C62167", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSRESU", + "name": "Units for Vital Signs Results", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66770", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.VSRESU_TEMP", + "name": "Units for Vital Signs Results (Subset TEMP)", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66770", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "C", + "decode": "Degree Celsius", + "coding": { + "code": "C42559", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "F", + "decode": "Degree Fahrenheit", + "coding": { + "code": "C44277", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "K", + "decode": "Kelvin", + "coding": { + "code": "C42537", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSRESU_WT", + "name": "Units for Vital Signs Results (Subset WT)", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66770", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "g", + "decode": "Gram", + "coding": { + "code": "C48155", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "kg", + "decode": "Kilogram", + "coding": { + "code": "C28252", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "LB", + "decode": "lb", + "coding": { + "code": "C48531", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSRESU_HT", + "name": "Units for Vital Signs Results (Subset HT)", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66770", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "cm", + "decode": "Centimeter", + "coding": { + "code": "C49668", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "in", + "decode": "Inch", + "coding": { + "code": "C48500", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "m", + "decode": "Meter", + "coding": { + "code": "C41139", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.UNIT_BMI", + "name": "Unit (Subset BMI)", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71620", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "kg/m2", + "decode": "Kilogram per Square Meter", + "coding": { + "code": "C49671", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "psi", + "decode": "Pounds per Square Inch", + "coding": { + "code": "C67334", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.LAT", + "name": "Laterality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99073", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "LEFT", + "decode": "", + "coding": { + "code": "C25229", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RIGHT", + "decode": "", + "coding": { + "code": "C25228", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.EGTESTCD", + "name": "ECG Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71153", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "AVCOND", + "decode": "Atrioventricular Conduction", + "coding": { + "code": "C111131", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AXISVOLT", + "decode": "Axis and Voltage", + "coding": { + "code": "C111132", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHYPTENL", + "decode": "Chamber Hypertrophy or Enlargement", + "coding": { + "code": "C111155", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EGHRMN", + "decode": "ECG Mean Heart Rate", + "coding": { + "code": "C119259", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INTP", + "decode": "Interpretation", + "coding": { + "code": "C41255", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "IVTIACD", + "decode": "Intraventricular-Intraatrial Conduction", + "coding": { + "code": "C111238", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PACEMAKR", + "decode": "Pacemaker", + "coding": { + "code": "C111285", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PRAG", + "decode": "PQ Interval, Aggregate", + "coding": { + "code": "C117773", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QRS_AXIS", + "decode": "QRS Axis", + "coding": { + "code": "C118165", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QRSAG", + "decode": "QRS Duration, Aggregate", + "coding": { + "code": "C117779", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTAG", + "decode": "QT Interval, Aggregate", + "coding": { + "code": "C117783", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTCBAG", + "decode": "QTcB Interval, Aggregate", + "coding": { + "code": "C117784", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTCFAG", + "decode": "QTcF Interval, Aggregate", + "coding": { + "code": "C117786", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RHYNOS", + "decode": "Rhythm Not Otherwise Specified", + "coding": { + "code": "C111307", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RRAG", + "decode": "RR Interval, Aggregate", + "coding": { + "code": "C117791", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SNRARRY", + "decode": "Sinus Node Rhythms and Arrhythmias", + "coding": { + "code": "C111312", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SPRARRY", + "decode": "Supraventricular Arrhythmias", + "coding": { + "code": "C111320", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SPRTARRY", + "decode": "Supraventricular Tachyarrhythmias", + "coding": { + "code": "C111321", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TECHQUAL", + "decode": "Technical Quality", + "coding": { + "code": "C117807", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VTARRY", + "decode": "Ventricular Arrhythmias", + "coding": { + "code": "C111330", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VTTARRY", + "decode": "Ventricular Tachyarrhythmias", + "coding": { + "code": "C111331", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.EGTEST", + "name": "ECG Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71152", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Atrioventricular Conduction", + "decode": "Atrioventricular Conduction", + "coding": { + "code": "C111131", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Axis and Voltage", + "decode": "Axis and Voltage", + "coding": { + "code": "C111132", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Chamber Hypertrophy or Enlargement", + "decode": "Chamber Hypertrophy or Enlargement", + "coding": { + "code": "C111155", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ECG Mean Heart Rate", + "decode": "ECG Mean Heart Rate", + "coding": { + "code": "C119259", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Interpretation", + "decode": "Interpretation", + "coding": { + "code": "C41255", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Intraventricular-Intraatrial Conduction", + "decode": "Intraventricular-Intraatrial Conduction", + "coding": { + "code": "C111238", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Pacemaker", + "decode": "Pacemaker", + "coding": { + "code": "C111285", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PR Interval, Aggregate", + "decode": "PQ Interval, Aggregate", + "coding": { + "code": "C117773", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QRS Axis", + "decode": "QRS Axis", + "coding": { + "code": "C118165", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QRS Duration, Aggregate", + "decode": "QRS Duration, Aggregate", + "coding": { + "code": "C117779", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QT Interval, Aggregate", + "decode": "QT Interval, Aggregate", + "coding": { + "code": "C117783", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTcB Interval, Aggregate", + "decode": "QTcB Interval, Aggregate", + "coding": { + "code": "C117784", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "QTcF Interval, Aggregate", + "decode": "QTcF Interval, Aggregate", + "coding": { + "code": "C117786", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Rhythm Not Otherwise Specified", + "decode": "Rhythm Not Otherwise Specified", + "coding": { + "code": "C111307", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RR Interval, Aggregate", + "decode": "RR Interval, Aggregate", + "coding": { + "code": "C117791", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Sinus Node Rhythms and Arrhythmias", + "decode": "Sinus Node Rhythms and Arrhythmias", + "coding": { + "code": "C111312", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Supraventricular Arrhythmias", + "decode": "Supraventricular Arrhythmias", + "coding": { + "code": "C111320", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Supraventricular Tachyarrhythmias", + "decode": "Supraventricular Tachyarrhythmias", + "coding": { + "code": "C111321", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Technical Quality", + "decode": "Technical Quality", + "coding": { + "code": "C117807", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ventricular Arrhythmias", + "decode": "Ventricular Arrhythmias", + "coding": { + "code": "C111330", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ventricular Tachyarrhythmias", + "decode": "Ventricular Tachyarrhythmias", + "coding": { + "code": "C111331", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.NORMABNM", + "name": "Normal Abnormal Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C101834", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EGSTRESC", + "name": "ECG Result", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71150", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EGMETHOD", + "name": "ECG Test Method", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71151", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EVAL", + "name": "Evaluator", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78735", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ADJUDICATION COMMITTEE", + "decode": "", + "coding": { + "code": "C78726", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INDEPENDENT ASSESSOR", + "decode": "", + "coding": { + "code": "C78720", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INVESTIGATOR", + "decode": "", + "coding": { + "code": "C25936", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VENDOR", + "decode": "", + "coding": { + "code": "C68608", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.FRM", + "name": "Dosage Form", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66726", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ROUTE", + "name": "Route of Administration Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66729", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LBTESTCD", + "name": "Laboratory Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C65047", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ALB", + "decode": "Albumin", + "coding": { + "code": "C64431", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ALP", + "decode": "Alkaline Phosphatase", + "coding": { + "code": "C64432", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ALT", + "decode": "Alanine Aminotransferase", + "coding": { + "code": "C64433", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ANISO", + "decode": "Anisocytes", + "coding": { + "code": "C74797", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AST", + "decode": "Aspartate Aminotransferase", + "coding": { + "code": "C64467", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BASO", + "decode": "Basophils", + "coding": { + "code": "C64470", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BICARB", + "decode": "Bicarbonate", + "coding": { + "code": "C74667", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BILI", + "decode": "Bilirubin", + "coding": { + "code": "C38037", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CA", + "decode": "Calcium", + "coding": { + "code": "C64488", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHOL", + "decode": "Cholesterol", + "coding": { + "code": "C105586", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CL", + "decode": "Chloride", + "coding": { + "code": "C64495", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "COLOR", + "decode": "Color", + "coding": { + "code": "C64546", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CREAT", + "decode": "Creatinine", + "coding": { + "code": "C64547", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "EOS", + "decode": "Eosinophils", + "coding": { + "code": "C64550", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "GGT", + "decode": "Gamma Glutamyl Transferase", + "coding": { + "code": "C64847", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "GLUC", + "decode": "Glucose", + "coding": { + "code": "C105585", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HBA1C", + "decode": "Glycated Hemoglobin", + "coding": { + "code": "C64849", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HBA1CHGB", + "decode": "Hemoglobin A1C/Hemoglobin", + "coding": { + "code": "C111207", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HCT", + "decode": "Erythrocyte Volume Fraction", + "coding": { + "code": "C64796", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HGB", + "decode": "Hemoglobin", + "coding": { + "code": "C64848", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "K", + "decode": "Potassium", + "coding": { + "code": "C64853", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "KETONES", + "decode": "Ketones", + "coding": { + "code": "C64854", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MACROCY", + "decode": "Macrocytes", + "coding": { + "code": "C64821", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MCH", + "decode": "Ery. Mean Corpuscular Hemoglobin", + "coding": { + "code": "C64797", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MCHC", + "decode": "Ery. Mean Corpuscular HGB Concentration", + "coding": { + "code": "C64798", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MCV", + "decode": "Ery. Mean Corpuscular Volume", + "coding": { + "code": "C64799", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MICROCY", + "decode": "Microcytes", + "coding": { + "code": "C64822", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MONO", + "decode": "Monocytes", + "coding": { + "code": "C64823", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NEUT", + "decode": "Neutrophils", + "coding": { + "code": "C63321", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NEUTB", + "decode": "Neutrophils Band Form", + "coding": { + "code": "C64830", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NEUTSG", + "decode": "Neutrophils, Segmented", + "coding": { + "code": "C81997", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NITRITE", + "decode": "Nitrite", + "coding": { + "code": "C64810", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OCCBLD", + "decode": "Occult Blood", + "coding": { + "code": "C74686", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PHOS", + "decode": "Inorganic Phosphate", + "coding": { + "code": "C64857", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PLAT", + "decode": "Platelets", + "coding": { + "code": "C51951", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "POIKILO", + "decode": "Poikilocytes", + "coding": { + "code": "C79602", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "POLYCHR", + "decode": "Polychromasia", + "coding": { + "code": "C64803", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PROT", + "decode": "Protein", + "coding": { + "code": "C64858", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RBC", + "decode": "Erythrocytes", + "coding": { + "code": "C51946", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SODIUM", + "decode": "Sodium", + "coding": { + "code": "C64809", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SPGRAV", + "decode": "Specific Gravity", + "coding": { + "code": "C64832", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "T3", + "decode": "Total T3", + "coding": { + "code": "C74747", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "T3UP", + "decode": "T3RU", + "coding": { + "code": "C74748", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "T4FR", + "decode": "Free T4", + "coding": { + "code": "C74786", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "T4FRIDX", + "decode": "Thyroxine, Free Index", + "coding": { + "code": "C170598", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TSH", + "decode": "Thyroid Stimulating Hormone", + "coding": { + "code": "C64813", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "URATE", + "decode": "Urate", + "coding": { + "code": "C64814", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "UREAN", + "decode": "Urea Nitrogen", + "coding": { + "code": "C125949", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "UROBIL", + "decode": "Urobilinogen", + "coding": { + "code": "C64816", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VITB12", + "decode": "Cobalamin", + "coding": { + "code": "C64817", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "VITB9", + "decode": "Folate", + "coding": { + "code": "C74676", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "WBC", + "decode": "Leukocytes", + "coding": { + "code": "C51948", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.LBTEST", + "name": "Laboratory Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67154", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Alanine Aminotransferase", + "decode": "Alanine Aminotransferase", + "coding": { + "code": "C64433", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Albumin", + "decode": "Albumin", + "coding": { + "code": "C64431", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Alkaline Phosphatase", + "decode": "Alkaline Phosphatase", + "coding": { + "code": "C64432", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Anisocytes", + "decode": "Anisocytes", + "coding": { + "code": "C74797", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Aspartate Aminotransferase", + "decode": "Aspartate Aminotransferase", + "coding": { + "code": "C64467", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Basophils", + "decode": "Basophils", + "coding": { + "code": "C64470", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Bicarbonate", + "decode": "Bicarbonate", + "coding": { + "code": "C74667", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Bilirubin", + "decode": "Bilirubin", + "coding": { + "code": "C38037", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Calcium", + "decode": "Calcium", + "coding": { + "code": "C64488", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Chloride", + "decode": "Chloride", + "coding": { + "code": "C64495", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Cholesterol", + "decode": "Cholesterol", + "coding": { + "code": "C105586", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Color", + "decode": "Color", + "coding": { + "code": "C64546", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Creatinine", + "decode": "Creatinine", + "coding": { + "code": "C64547", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Eosinophils", + "decode": "Eosinophils", + "coding": { + "code": "C64550", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ery. Mean Corpuscular Hemoglobin", + "decode": "Ery. Mean Corpuscular Hemoglobin", + "coding": { + "code": "C64797", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ery. Mean Corpuscular HGB Concentration", + "decode": "Ery. Mean Corpuscular HGB Concentration", + "coding": { + "code": "C64798", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ery. Mean Corpuscular Volume", + "decode": "Ery. Mean Corpuscular Volume", + "coding": { + "code": "C64799", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Erythrocytes", + "decode": "Erythrocytes", + "coding": { + "code": "C51946", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Gamma Glutamyl Transferase", + "decode": "Gamma Glutamyl Transferase", + "coding": { + "code": "C64847", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Glucose", + "decode": "Glucose", + "coding": { + "code": "C105585", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Hematocrit", + "decode": "Erythrocyte Volume Fraction", + "coding": { + "code": "C64796", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Hemoglobin A1C", + "decode": "Glycated Hemoglobin", + "coding": { + "code": "C64849", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Hemoglobin A1C/Hemoglobin", + "decode": "Hemoglobin A1C/Hemoglobin", + "coding": { + "code": "C111207", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Hemoglobin", + "decode": "Hemoglobin", + "coding": { + "code": "C64848", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Ketones", + "decode": "Ketones", + "coding": { + "code": "C64854", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Leukocytes", + "decode": "Leukocytes", + "coding": { + "code": "C51948", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Macrocytes", + "decode": "Macrocytes", + "coding": { + "code": "C64821", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Microcytes", + "decode": "Microcytes", + "coding": { + "code": "C64822", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Monocytes", + "decode": "Monocytes", + "coding": { + "code": "C64823", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Neutrophils Band Form", + "decode": "Neutrophils Band Form", + "coding": { + "code": "C64830", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Neutrophils", + "decode": "Neutrophils", + "coding": { + "code": "C63321", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Neutrophils, Segmented", + "decode": "Neutrophils, Segmented", + "coding": { + "code": "C81997", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Nitrite", + "decode": "Nitrite", + "coding": { + "code": "C64810", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Occult Blood", + "decode": "Occult Blood", + "coding": { + "code": "C74686", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Phosphate", + "decode": "Inorganic Phosphate", + "coding": { + "code": "C64857", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Platelets", + "decode": "Platelets", + "coding": { + "code": "C51951", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Poikilocytes", + "decode": "Poikilocytes", + "coding": { + "code": "C79602", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Polychromasia", + "decode": "Polychromasia", + "coding": { + "code": "C64803", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Potassium", + "decode": "Potassium", + "coding": { + "code": "C64853", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Protein", + "decode": "Protein", + "coding": { + "code": "C64858", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Sodium", + "decode": "Sodium", + "coding": { + "code": "C64809", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Specific Gravity", + "decode": "Specific Gravity", + "coding": { + "code": "C64832", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Thyrotropin", + "decode": "Thyroid Stimulating Hormone", + "coding": { + "code": "C64813", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Thyroxine, Free Index", + "decode": "Thyroxine, Free Index", + "coding": { + "code": "C170598", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Thyroxine, Free", + "decode": "Free T4", + "coding": { + "code": "C74786", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Triiodothyronine Uptake", + "decode": "T3RU", + "coding": { + "code": "C74748", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Triiodothyronine", + "decode": "Total T3", + "coding": { + "code": "C74747", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Urate", + "decode": "Urate", + "coding": { + "code": "C64814", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Urea Nitrogen", + "decode": "Urea Nitrogen", + "coding": { + "code": "C125949", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Urobilinogen", + "decode": "Urobilinogen", + "coding": { + "code": "C64816", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Vitamin B12", + "decode": "Cobalamin", + "coding": { + "code": "C64817", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Vitamin B9", + "decode": "Folate", + "coding": { + "code": "C74676", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.LBSTRESC", + "name": "Laboratory Test Standard Character Result", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C102580", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NRIND", + "name": "Reference Range Indicator", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78736", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SPECTYPE", + "name": "Specimen Type", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78734", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "BLOOD", + "decode": "Peripheral Blood", + "coding": { + "code": "C12434", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ERYTHROCYTES", + "decode": "RBC", + "coding": { + "code": "C12521", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SERUM OR PLASMA", + "decode": "Ser/Plas", + "coding": { + "code": "C105706", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "STOOL", + "decode": "Feces", + "coding": { + "code": "C13234", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "URINE SEDIMENT", + "decode": "", + "coding": { + "code": "C158282", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "URINE", + "decode": "", + "coding": { + "code": "C13283", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CEREBROSPINAL FLUID", + "decode": "CSF", + "coding": { + "code": "C12692", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FLUID", + "decode": "", + "coding": { + "code": "C13236", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SERUM", + "decode": "Sera", + "coding": { + "code": "C13325", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SWABBED MATERIAL", + "decode": "", + "coding": { + "code": "C150895", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.METHOD", + "name": "Method", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C85492", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "DIPSTICK MEASUREMENT METHOD", + "decode": "", + "coding": { + "code": "C178142", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY", + "decode": "Chemiluminescent Magnetic Microparticle Immunoassay", + "coding": { + "code": "C172557", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "FLUORESCENT IMMUNOASSAY", + "decode": "Fluorescent Antibody Assay", + "coding": { + "code": "C17370", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "HEMAGGLUTINATION ASSAY", + "decode": "", + "coding": { + "code": "C130173", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "IMMUNOBLOT", + "decode": "", + "coding": { + "code": "C17638", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "LINE PROBE ASSAY", + "decode": "LiPA", + "coding": { + "code": "C102656", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "POLYMERASE CHAIN REACTION", + "decode": "PCR", + "coding": { + "code": "C17003", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "RAPID IMMUNOASSAY", + "decode": "", + "coding": { + "code": "C178031", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.MBTESTCD", + "name": "Microbiology Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C120527", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "TPADNA", + "decode": "Treponema pallidum DNA", + "coding": { + "code": "C198341", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TPLAB", + "decode": "" + } + ] + }, + { + "OID": "CL.MBTEST", + "name": "Microbiology Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C120528", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Treponema pallidum DNA", + "decode": "Treponema pallidum DNA", + "coding": { + "code": "C198341", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.MBFTSDTL", + "name": "Microbiology Findings Test Details", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C174225", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "DETECTION", + "decode": "", + "coding": { + "code": "C174330", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.DIR", + "name": "Directionality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99074", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "LOWER", + "decode": "", + "coding": { + "code": "C25309", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MIDLINE", + "decode": "", + "coding": { + "code": "C81170", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "UPPER", + "decode": "", + "coding": { + "code": "C25355", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.AESEV", + "name": "Severity/Intensity Scale for Adverse Events", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66769", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ACN", + "name": "Action Taken with Study Treatment", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66767", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.OUT", + "name": "Outcome of Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66768", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TSPARMCD", + "name": "Trial Summary Parameter Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66738", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ADAPT", + "decode": "Adaptive Design", + "coding": { + "code": "C146995", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AGEMAX", + "decode": "Planned Maximum Age of Subjects", + "coding": { + "code": "C49694", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "AGEMIN", + "decode": "Planned Minimum Age of Subjects", + "coding": { + "code": "C49693", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "COMPTRT", + "decode": "Comparative Treatment Name", + "coding": { + "code": "C68612", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CRMDUR", + "decode": "Confirmed Response Minimum Duration", + "coding": { + "code": "C98715", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DOSE", + "decode": "Dose Level", + "coding": { + "code": "C25488", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DOSFRQ", + "decode": "Dosing Frequency", + "coding": { + "code": "C89081", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "DOSU", + "decode": "Dose Units", + "coding": { + "code": "C73558", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INDIC", + "decode": "Indication for Use", + "coding": { + "code": "C112038", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INTMODEL", + "decode": "Intervention Model", + "coding": { + "code": "C98746", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "INTTYPE", + "decode": "Intervention Type", + "coding": { + "code": "C98747", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "NARMS", + "decode": "Planned Number of Arms", + "coding": { + "code": "C98771", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OBJPRIM", + "decode": "Study Primary Objective", + "coding": { + "code": "C85826", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OBJSEC", + "decode": "Study Secondary Objective", + "coding": { + "code": "C85827", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OUTMSPRI", + "decode": "Primary Outcome Measure", + "coding": { + "code": "C98772", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "OUTMSSEC", + "decode": "Secondary Outcome Measure", + "coding": { + "code": "C98781", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PLANSUB", + "decode": "Anticipated Enrollment", + "coding": { + "code": "C49692", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "PTRTDUR", + "decode": "Planned Treatment Duration", + "coding": { + "code": "C139276", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "ROUTE", + "decode": "Route of Administration", + "coding": { + "code": "C38114", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SEXPOP", + "decode": "Sex of Participants", + "coding": { + "code": "C49696", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "SPONSOR", + "decode": "Clinical Study Sponsor", + "coding": { + "code": "C70793", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "STYPE", + "decode": "Study Type", + "coding": { + "code": "C142175", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TBLIND", + "decode": "Study Blinding Design", + "coding": { + "code": "C49658", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "THERAREA", + "decode": "Therapeutic Area", + "coding": { + "code": "C101302", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TINDTP", + "decode": "Trial Intent Type", + "coding": { + "code": "C49652", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TITLE", + "decode": "Official Study Title", + "coding": { + "code": "C49802", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TPHASE", + "decode": "Trial Phase", + "coding": { + "code": "C48281", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TRT", + "decode": "Investigational Interventional", + "coding": { + "code": "C41161", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TTYPE", + "decode": "Trial Scope", + "coding": { + "code": "C49660", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.TSPARM", + "name": "Trial Summary Parameter Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67152", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Adaptive Design", + "decode": "Adaptive Design", + "coding": { + "code": "C146995", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Clinical Study Sponsor", + "decode": "Clinical Study Sponsor", + "coding": { + "code": "C70793", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Comparative Treatment Name", + "decode": "Comparative Treatment Name", + "coding": { + "code": "C68612", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Confirmed Response Minimum Duration", + "decode": "Confirmed Response Minimum Duration", + "coding": { + "code": "C98715", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Dose per Administration", + "decode": "Dose Level", + "coding": { + "code": "C25488", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Dose Units", + "decode": "Dose Units", + "coding": { + "code": "C73558", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Dosing Frequency", + "decode": "Dosing Frequency", + "coding": { + "code": "C89081", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Intervention Model", + "decode": "Intervention Model", + "coding": { + "code": "C98746", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Intervention Type", + "decode": "Intervention Type", + "coding": { + "code": "C98747", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Investigational Therapy or Treatment", + "decode": "Investigational Interventional", + "coding": { + "code": "C41161", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Maximum Age of Subjects", + "decode": "Planned Maximum Age of Subjects", + "coding": { + "code": "C49694", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Minimum Age of Subjects", + "decode": "Planned Minimum Age of Subjects", + "coding": { + "code": "C49693", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Number of Arms", + "decode": "Planned Number of Arms", + "coding": { + "code": "C98771", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Number of Subjects", + "decode": "Anticipated Enrollment", + "coding": { + "code": "C49692", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Planned Treatment Duration", + "decode": "Planned Treatment Duration", + "coding": { + "code": "C139276", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Primary Outcome Measure", + "decode": "Primary Outcome Measure", + "coding": { + "code": "C98772", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Route of Administration", + "decode": "Route of Administration", + "coding": { + "code": "C38114", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Secondary Outcome Measure", + "decode": "Secondary Outcome Measure", + "coding": { + "code": "C98781", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Sex of Participants", + "decode": "Sex of Participants", + "coding": { + "code": "C49696", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Study Type", + "decode": "Study Type", + "coding": { + "code": "C142175", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Therapeutic Area", + "decode": "Therapeutic Area", + "coding": { + "code": "C101302", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Blinding Schema", + "decode": "Study Blinding Design", + "coding": { + "code": "C49658", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Disease/Condition Indication", + "decode": "Indication for Use", + "coding": { + "code": "C112038", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Intent Type", + "decode": "Trial Intent Type", + "coding": { + "code": "C49652", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Phase Classification", + "decode": "Trial Phase", + "coding": { + "code": "C48281", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Primary Objective", + "decode": "Study Primary Objective", + "coding": { + "code": "C85826", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Secondary Objective", + "decode": "Study Secondary Objective", + "coding": { + "code": "C85827", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Title", + "decode": "Official Study Title", + "coding": { + "code": "C49802", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Trial Type", + "decode": "Trial Scope", + "coding": { + "code": "C49660", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.DICTNAM", + "name": "Dictionary Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66788", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.IECAT", + "name": "Category of Inclusion/Exclusion", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66797", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.CNTMODE", + "name": "Mode of Subject Contact", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C171445", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "IN PERSON", + "decode": "In-Person", + "coding": { + "code": "C175574", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "TELEPHONE CALL", + "decode": "", + "coding": { + "code": "C171537", + "codeSystem": "nci:ExtCodeID" + } + } + ] + } + ], + "methods": [], + "comments": [], + "standards": [ + { + "OID": "STD.SDTMIG", + "name": "SDTMIG", + "type": "IG", + "version": "3.4", + "status": "FINAL" + }, + { + "OID": "STD.SDTMCT", + "name": "CDISC/NCI", + "type": "CT", + "version": "2024-09-27", + "status": "FINAL", + "publishingSet": "SDTM" + } + ], + "annotatedCRF": [], + "concepts": [], + "conceptProperties": [] +} \ No newline at end of file diff --git a/src/generators/define/define_generator.py b/src/generators/define/define_generator.py index 75119f9..8e3640f 100644 --- a/src/generators/define/define_generator.py +++ b/src/generators/define/define_generator.py @@ -208,6 +208,7 @@ def _write_define(self, odm: Any) -> None: :param odm: the instantiated odmlib Define-XML ODM object """ + Path(self.define_file).parent.mkdir(parents=True, exist_ok=True) odm.write_xml(self.define_file) def _check_file_existence(self) -> None: diff --git a/src/generators/define/output/define.xml b/src/generators/define/output/define.xml new file mode 100644 index 0000000..b0c56ab --- /dev/null +++ b/src/generators/define/output/define.xml @@ -0,0 +1,9199 @@ + + + + + LZZT - NEW + Safety and Efficacy of the Xanomeline Transdermal Therapeutic System + (TTS) in Patients with Mild to Moderate Alzheimer's Disease + LZZT - NEW + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + 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