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Clintrial panel and item autocreation option

By default, the CIS software creates a Clintrial protocol, panels, and panel items during synchronization if they do not already exist. If a protocol, panels, and panel items exist, and new metadata is received in mapping definitions, the CIS software updates the protocol, panels, and panel items to match the mapping definitions.

This behavior is optional. When you define or update a synchronization connection, you can specify whether you want the CIS software to create or update the protocol, panels, and panel items.

The following table summarizes the impact of choosing for the CIS software not to create or update Clintrial protocol, panels, and panel items.

Software area

Effect on synchronization if Create panels and items = No

Study book creation

None.

Codelist creation

None.

Mappings

The CIS software does not create the panels and items defined by mapping definitions. However, the following validation occurs to determine whether the Clintrial panels or items match the incoming mappings:

  • When the CONTEXTPANEL tag is received, the CIS software verifies that a CONTEXT panel exists for the protocol. If a CONTEXT panel does not exist, validation fails.
  • For CTITEM tags inside the CONTEXTPANEL tag, no additional validation is performed.
  • When a CTPANEL tag is received, the CIS software verifies that the panel exists and is installed. If the panel does not exist or is not installed, validation fails.
  • For a CTITEM tag inside the CTPANEL tag, the CIS software verifies that the item exists in the panel. The item type is not checked. If the item does not exist in the panel, validation fails
  • The CIS software ignores all other properties of the panel from the mappings, including the master-detail information.

If validation fails, synchronization stops processing. To continue, make corrections in the Clintrial software or in the mapping definitions and the CIS software:

  • Alter the protocol in Clintrial Design so it passes the CIS validation.
  • Remove the synchronization connection in the CIS software, alter the mapping definitions so they will pass validation, and re-create the synchronization connection to the same protocol.

Rules

The CIS software does not create or update Clintrial rules and derivations. No validation checks are performed to verify that rules or derivations exist in the Clintrial protocol.

Protocols

The CIS software does not create a Clintrial protocol. If the protocol specified in the synchronization connection definition does not exist, synchronization fails.

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