MAPPING

entimo’s data mapping tool facilitates the transformation of datasets to arbitrary target structures including SDTM. The mapping tool provides a comfortable visual interface to create mapping definitions. Thus minimum programming skills are required. A broad number of predefined standard conversion functions are available in the tool and can be easily enhanced with specific user-defined actions.

Mappings are defined based on metadata which can be easily imported or derived from available datasets. Therefore, you can begin with the definition of mappings even before real datasets are available. Prior to mapping creation, you can analyze datasets with a comprehensive profiling tool.

Based on mapping definitions, executable SAS programs for the transformation of real data are automatically generated. Datasets are assigned to programs at run-time through program parameters. Syntax of other target languages is generally supported. The current release however, only supports the SAS language.

Finally, define.xml can be generated using the metadata managed in a central repository.

Key Features Overview

Flexible mapping definition rules

• Metadata based mapping definition

• Multi-level metadata

• Multiple sources related to multiple targets

• Automatic mapping of source and target variables

• Reusable mappings

Standard and user defined conversion actions

• Comprehensive pre-defined conversion actions:
  Assigning, renaming and dropping of existing variables
  Creation of new variables
  Conversion of types using extendible list of formats
  Decoding using format catalogs and code lists
  Combine and split of values
  Selection of string parts
  Assignment of fixed values
  Assignment of labels and attributes to variables

• Definition of standard actions and templates for repeated user tasks

• Direct entry of SAS code for specific transformations

• Transposing tasks available

Regulatory compliance

• Fully compliant with FDA 21 CFR Part 11 and ICH GCP regulations

• Support of CDISC ODM and SDTM

• Generation of CRT-DD (define.xml) with CRF annotation

General features

• Secure central metadata repository

• Easy connectivity with external data sources -
  EDC | CDMS | CTMS | EDMS

• Profiling facility for multiple datasets

• Access to customer-specific and standard codelists, catalogs and dictionaries

Full traceability and transparency

• Audit trail with human readable reports

• Complete object change history

• Full log of user actions

• Definition of dependencies between objects

• Version control

• Electronic signatures flexibly configurable

Click here to download this page as entimICE DARE flyer.

The data mapping tool is based on entimICE® - entimo's fully GCP and 21 CFR Part 11 compliant, modular and controlled e-clinical solution platform.

Further Info

Donwload this page as flyer

Request more info about entimICE Mapping here...

If you need Adobe Acrobat then click here...