CDISC（Clinical Data Interchange Standards Consortium）臨床數據交換標準協會就如何收集數據、收集什么類型的數據以及如何將數據提交給負責審批新藥的機構建立起了一套標準。涉及臨床研究電子數據的獲取、交換、存檔、提交的全過程。下表是CDISC的細分標準^[1]：

StandardDescription

Study Data Tabulation Model (SDTM)	The content standard for regulatory submission of case report form data abulations from clinical research studies.
Analysis Data Model (ADaM)	The content standard for regulatory submission of analysis datasets and associated files.
Operational Data Model (ODM)	The XML-based content and format standard for the acquisition, exchange, reporting or submission, and archival of case report form (CRF)-based clinical research data.
Laboratory Data Model (LAB)	The content and format standard for data transfer between clinical laboratories and study sponsors/CROs.
Case Report Tabulation Data Definition Specification (CRTDDS) – (define.xml)	The XML-based content and format standard referenced by the FDA as the specification for the data definitions for CDISC SDTM datasets. This standard, also known as define.xml, is an extension of the ODM.
Standard for Exchange of Nonclinical Data (SEND)	An extension of the SDTM standard for submission of data from pre-clinical studies.
Protocol Representation (PR)	The content and format standard supporting the interchange of clinical trial protocol information. This is a collaborative effort with Health Level Seven (HL7).
Trial Design Model (TDM)	The content standard that defines the structure for representing the planned sequence of events and the treatment plan of a trial. This is a subset of the SDTM and Protocol Representation.
Clinical Data Acquisition Standards Harmonization (CDASH)	A CDISC-led collaborabtive initiative to develop the content standard for a minimum set of data collection fields in case report forms. This standard is based upon the SDTM.
Terminology	The controlled standard vocabulary and code sets for the all CDISC models/standards.
Glossary	The CDISC dictionary of terms and their definitions, related to the electronic acquisition, exchange and reporting of clinical research information. Abbreviations and acronyms are also listed.

CDISC標準涵蓋兩方面：內容（data，metadata，terminology）和格式（XML-based）標準。從 Introducing the CDISC Standards¹截取張圖說明各個標準在臨床試驗過程中的分布：

ODM-XML

ODM-XML定義了一種與供應商無關、獨立于平臺的格式，用于交換和歸檔（臨床的和轉化而來的）研究數據及其相關元數據、管理數據、參考數據和審計信息。
ODM-XML有助于符合法規的元數據和數據的獲取、存檔和交換。ODM-XML已經成為許多EDC表示CRF內容的首選格式。
下面兩幅圖展示了ODM文件的格式：


XML文件文本內容舉例：

CDASH

用于CRF基礎數據收集字段的內容標準，基于SDTM標準制定。和SDTM對應，CDASH按領域劃分為：
Special-purpose domains:

• CO- Comments
• DM- Demographics

Interventions class domains:

• CM- Prior and concomitant medications
• EC- Exposure as Collected and eX- Exposure
• PR- Procedures
• SU- Substance use

Events class domains:

• AE- Adverse events
• CE- Clinical events
• DS-Disposition
• DV- Protocol deviations
• HO- Healthcare encounters
• MH- Medical history

Finding class domains:

• DA- Drug Accountability
• DD- Death details
• EG- ECG Test results
• IE -Inclusion/Exclusion Criteria not met
• LB- Laboratory Test results
• MB- Microbiology Specimen
• MS- Microbiology susceptibility
• MI- Microscopic Findings
• PC-Pharmacokinetics Sampling
• PE- Physical examination
• QRS- Questionnaires, Ratings, and Scales
• RP-Reproductive System Findings
• RS-Disease response and Clin classification
• SC- Subject characteristics
• TU- Tumor /Lesion identification domain
• TR- Lesion results
• VS- Vital signs
• FA- Findings about events or interventions
• SR-Skin response

Associated Persons Domain

• AP- Associated Persons

SDTM

通過不同途徑收集的臨床研究數據，匯總成SDTM數據集。

SDTM定義domains如下圖所示：

ADaM

有SDTM了，為什么還要ADaM？看看兩者的區別^[1]：

SDTMADaM

Contains the raw source data and limited derived data	Contains the derived data, both variables and observations, and even entire datasets, that are derived from the raw data. May also contain rawsource data to facilitate review and sensitivity analysis.
The variables allowed in each domain are restricted by the SDTM model	ADaM specifies core variables to be present in analysis data sets yet additional variables and observations can be added if they are needed for traceability and/or facilitation of analyses, provided that rules about when to derive data as rows and when to derive data as columns are followed.
There is no redundancy of variables within SDTM in that a specific variable, such as treatment, is found in only one SDTM domain.	There is redundancy of variables across different analysis datasets to support analysis. For instance, treatment variable(s) would be expected to be in every analysis dataset.
Generally uses character variables, such as character date strings.	Numeric values are included when needed for analysis purposes, such as numeric date values.
Each domain has a specific topic and contains only those variables related to that topic.	Contains variables and observations that may be obtained from a variety of domains. For example, a responder analysis may be based on information obtained from laboratory, imaging, and /or questionnaire data.

Define-XML

Ref:

Introducing the CDISC Standards - New Efficiencies for Medical Research

www.cdisc.org

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