CDISC Compliance Check Application

The CDISC compliance check application is a system that contains a metadata definition of the SDTM and ADaM standards and the available CDISC controlled terminology. The CDISC compliance check application runs an enhanced list of checks to verify compliance of both data and metadata against the current CDISC standards such as SDTM, ADaM, controlled terminology (CT) and define.xml. The CDISC compliance issues are logged in an exception table. A flexible check report generator creates a set of reports for further processing either in paper, electronic or .xml format.

Compliance Check Services

Based on this compliance check application, Business & Decision Life Sciences has developed a set of services. These to ensure the sponsor's CDISC datasets and metadata are of excellent quality and fully compliant with the current CDISC requirements.

These include :

• Generating a compliance report on the datasets and metadata (define.xml)
• Developing an in-depth analysis of the identified issues, together with recommendations on how to resolve these inconsistencies

Additionally, Business & Decision Life Sciences can :

• Apply all corrections on the data/metadata of the previously identified issues
• Support the sponsor to develop, integrate and maintain a CDISC compliance check system

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