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Overview

To promote the adoption of the standards for clinical trials as defined by the Clinical Data Interchange Standards Consortium (CDISC), we developed a metadata repository, the eClinical MDR App, a free, open-source application.  The App supports easy local reference to a database of metadata tables from CDISC Library for Data Collection and Controlled Terminology and example annotated CRFs.  It allows sponsors to define and view annotated Case Report Forms (CRFs) versions.  The data in the eClinical MDR is readily available to other applications through an Application Programming Interface (API).  Our goal is to facilitate the use of CDISC standards during the data collection phase of the clinical trial and thus positively affect the analysis and reporting phases. 

The intended audience includes those involved in clinical trial design, operation,  analysis, and regulatory data submission.

  • Pharmaceutical and BioTech Companies

  • CROs

  • Universities

  • Developers

This User Guide aims to provide this diverse group with technical information to enable them to understand the features and design of the eCRF MDR App. More detailed technical information is available in the implementation, tests, and installation sections of the User Guide.   

 

A MetaData Repository (MDR) is a database created to store metadata. Metadata is information about the structures that contain the actual data.  It is the single point of reference – the source of truth – for information about the data used across the platforms. An MDR for a clinical research platform holds the following:

1.    Data Definitions, Naming Standards, Instructions and Rules to be followed,

2.    Structure, Tables of Forms/Lists (representations of data) and

3.    Workflow (the processes that are followed for the data). 

The MDR sits alongside the clinical Data Repository, or the actual clinical data collected, whose structure is derived from the Metadata Repository.

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Background

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What is a Metadata Repository?
What is CDASH?

Clinical Data Acquisition Standards Harmonization (CDASH) is an international standards organization for clinical research.  According to the Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials:

 

'Clinical Data Acquisition Standards Harmonization (CDASH) establishes a standard way to collect data across studies.  

The CDASH Model, the CDASH Implementation Guide (CDASHIG), and the CDASHIG metadata tables
define basic standards for collecting clinical trial data and how to implement the standard for specific case report forms (CRFs).

The metadata tables for domains are imported to the eCRF MDR App from the CDISC Library.  Examples CRFs are taken from the Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials, CDASHIG V2.2 which is the latest release.  The App can accommodate additional releases. 

What is the CDISC 360 Vision?

According to CDISC:

Although the CDASH standard was originally developed for use in regulatory submissions, it can be used by any organization or individual involved in the collection, preparation, and analysis of clinical research data that may also be used for other purposes, including publication, warehousing, and meta-analyses. Data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data reviews. The CDASH standard directly supports the production of clinical data collection instruments. Through this support, the standard also contributes to: consistency and detail in representations of research protocol concepts:


• Streamlined processes within medical research
• Development of a corporate library of standardized CRFs
• Use of metadata repositories
• Reporting and regulatory submission
• Data warehouse population
• Data archiving
• Post-marketing studies/safety surveillance.'

 

'360 is the CDISC initiative aimed at implementing standards as linked metadata with a conceptual foundation providing the additional semantics needed to support metadata driven-automation across the end-to-end clinical research data lifecycle.

 

New software tools will be able to consume this new metadata to ease standards implementations while increasing data processing efficiencies.

 

Standards-based metadata-driven automation is critical in realizing the primary benefits expected of the CDISC standards: substantially improved efficiency, consistency, and re-usability across the clinical research data lifecycle. These benefits drive the return on investment in the CDISC standards implementations expected by CDISC stakeholders.'

What is CDASH?

Clinical Data Acquisition Standards Harmonization (CDASH) is an international standards organization for clinical research.  According to the Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials:

 

'Clinical Data Acquisition Standards Harmonization (CDASH) establishes a standard way to collect data across studies.  

The CDASH Model, the CDASH Implementation Guide (CDASHIG), and the CDASHIG metadata tables
define basic standards for collecting clinical trial data and how to implement the standard for specific case report forms (CRFs).

The metadata tables for domains are imported to the eCRF MDR App from the CDISC Library.  Examples CRFs are taken from the Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials, CDASHIG V2.2 which is the latest release.  The App can accommodate additional releases. 

What is the CDISC 360 Vision?

According to CDISC:

Although the CDASH standard was originally developed for use in regulatory submissions, it can be used by any organization or individual involved in the collection, preparation, and analysis of clinical research data that may also be used for other purposes, including publication, warehousing, and meta-analyses. Data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data reviews. The CDASH standard directly supports the production of clinical data collection instruments. Through this support, the standard also contributes to: consistency and detail in representations of research protocol concepts:


• Streamlined processes within medical research
• Development of a corporate library of standardized CRFs
• Use of metadata repositories
• Reporting and regulatory submission
• Data warehouse population
• Data archiving
• Post-marketing studies/safety surveillance.'

 

'360 is the CDISC initiative aimed at implementing standards as linked metadata with a conceptual foundation providing the additional semantics needed to support metadata driven-automation across the end-to-end clinical research data lifecycle.

 

New software tools will be able to consume this new metadata to ease standards implementations while increasing data processing efficiencies.

 

Standards-based metadata-driven automation is critical in realizing the primary benefits expected of the CDISC standards: substantially improved efficiency, consistency, and re-usability across the clinical research data lifecycle. These benefits drive the return on investment in the CDISC standards implementations expected by CDISC stakeholders.'

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