Previous Topic

Next Topic

Book Contents

Data transfer summary

The following diagram and table summarize the metadata and data transfers that occur during the development and production phases of an integrated study.

Embedded WMF File Template

Data/Metadata

From

To

Process

Clintrial protocol metadata

Clintrial software

CIS Library

When you register a Clintrial protocol in a CIS library, the CIS software translates the protocol to study MedML, generates Clintrial mappings, transfers the MedML, and stores the study metadata and mappings in the library. This occurs over an OLEDB connection.

Central Designer deployment package

Central Designer software

InForm software

When you deploy a study created in the Central Designer software to the InForm software, the Central Designer study components and workflow are translated to InForm study components. The conversion to InForm study components is based on both the data definition of each study component and the layout specified for each form or item in the Central Designer software.

For more information, see the information about Central Designer and InForm study component correspondences in the Central Designer documentation.

InForm study metadata and EDC clinical data

InForm software

Clintrial software via CIS software

When you synchronize a study definition or clinical data from the InForm software to a Clintrial protocol, the CIS software:

  1. Initiates the synchronization.
  2. Creates the protocol if it does not already exist.
  3. Gets metadata and data transactions from the InForm software through the InForm Adapter.
  4. Puts the metadata and data into the Clintrial database.
  5. Gets transactions from the Clintrial software for queries only and sends them back to the InForm software through the InForm Adapter.

Clintrial queries

Clintrial software

InForm software

When a study is designed to validate EDC data with Clintrial rules and derivations, and the validation results in the generation of queries.

Send Feedback