CDISC Metabase

A Clinical Metabase is a database that contains all the data generated by a sponsor's clinical trials. The data are first consolidated in the Metabase and are then harmonized by recoding so that searches can be undertaken across all the trials.

Standard data format

As ARONE was looking to pool heterogeneous data from several clinical trials, we naturally opted for the CDISC ODM XML standard.

CDISC (Clinical Data Interchange Standards Consortium) is an organization that develops and supports data storage and exchange standards.

The ODM (Operational Data Model) standard applies to the acquisition, exchange and archiving of clinical data.

Building the Metabase

A Metabase is built up in a number of successive steps.

Data conversion

This first step consists in taking study source data that was not managed in accordance with the CDISC standard, and converting it to the CDISC XML format. The DbStruct module can be used to do this by placing source data in the "right field" of the XML structure.

Data import

The Transform Data module can then be used to import the XML file generated by the DbStruct module into the database.

Data harmonization

The Transform Data module recodes all data into a single format common to all studies (each study may originally have adopted different coding for the same information: AE severity, etc.). No information is lost during the coding and all source values are stored independently of the transcoded data. Users can at all times access:

  • the source data
  • the transcoded data
  • information about the source of the data (source table and column).

Purpose of the Metabase and data searches

The search module is based on technology by SAP Business Objects. The user opens the Web Intelligence module and connects to the "Business Objects" solution. This organizes the data logically in a practical, industry-oriented manner, not based on technical aspects: the level of abstraction provided by Business Objects means that anyone, with or without CDISC-related skills, can search the database.

The search module allows users through a simple browser to:

  • access Metabase data through a simple, intuitive interface,
  • consult interactive analyses,
  • explore the data from different angles,
  • prepare and distribute ad hoc reports,
  • ...

Other reporting tools directly based on the Oracle database can also be provided.

Security and administration

The Metabase administration module can be used to:

  • create users,
  • add studies for import of their data,
  • define rights for studies and define selections of studies,
  • manage coding lists (thesaurus),
  • ...

Users can pre-define their own selection of studies (their "projects") as long as they have access rights to these studies. The search module then searches only the data derived from the trials selected by the user.

Data export

Various interfaces may be used to export data from the Metabase to

  • the regulatory authorities,
  • safety (pharmacovigilance) databases.

Audit

Every task accomplished with the different modules is tracked and logged, forming an audit trail. Authorized users can search audit trail data using the search module.

Our services

ARONE can provide you with support in setting up your Metabase:

  • analyzing source data and documenting conversion settings,
  • preparing the conversion and generating CDISC XML files,
  • importing data,
  • harmonizing data,
  • creating specific tables in the Business Objects environment,
  • designing reports,
  • administering the Metabase,
  • hosting the Metabase.

References

ARONE has already set up Metabases containing data from up to 30 phase I to III clinical studies.


Interface with Projection® eCRF

ARONE can manage the full clinical data processing cycle from end to end. And make sure you take full advantage of the simplified integration of data from Projection® eCRF.


Arone's services

Arone also provides additional Metabase-related services such as:

  • study data formatting and loading into the Metabase
  • Metabase searches and report writing
  • hosting
  • training
  • support

Technical requirements

METABASE dbStruct is supported by Windows and requires Microsoft .net framework 3.5.

The other modules need a web browser and run smoothly on Microsoft Internet Explorer and Mozilla Firefox.


CDISC

See the CDISC website for more information on the standard used by the Metabase system.

SAP Business Intelligence

The Metabase system uses technology by SAP Business Intelligence, the global leader in data mining.