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Study book generation
After generating a complete set of XML definitions for the study books of a protocol, the CIS software creates the study books and their components.
Study book autocreation can occur:
- When a user requests study book autocreation by clicking the Create Study Books button on the Actions tab of the CIS Synchronizations page in the CIS Administration application.
- When the CIS software detects that autocreation is necessary. The CIS software determines that autocreation is needed if it processes any of the following types of transactions from the InForm software:
- STUDYVERSION XML definitions.
- Data mappings.
- Any InForm metadata that causes an autogenerated codelist to be attached to a Clintrial item. Examples are metadata definitions for radio controls and dropdown lists.
The CIS software does not autocreate study books if any of the following are true:
- The protocol is closed for revision or is locked.
- The synchronization connection is not defined to autocreate study books.
When processing the study book XML created in the first phase of study book autocreation, the CIS software:
- Adds elements that do not exist in the protocol database, if the elements have a valid definition.
- Regenerates elements that already exist in the protocol database, if the elements have a valid definition.
Note: If a non-CIS user, such as a user of the Clintrial Design module, has updated a pre-existing element, the CIS software ignores the element and does not regenerate it during regular synchronization processing. However, if you request immediate study book generation by using the Actions tab of the CIS Synchronizations page, you can specify that the CIS software regenerates elements updated by a non-CIS user and overwrites those elements.
The CIS software can detect most changes that a user makes to a protocol with the Clintrial Design module. However, some changes are not detectable by the CIS software. If a user of the Design module makes any of the following changes, the CIS software does not detect them and overwrites those changes:
- Deleting the last page template from a block.
- Deleting the last block from a study book.
- Changing the order of page sections in a page template.
- Associates related elements. For example, the CIS software associates page sections with their page templates and page templates with their blocks.
- Truncates block titles to 20 characters, if necessary.
- Truncates page titles to 30 characters, if necessary.
When autocreating page sections, the CIS software:
- Makes the layout of controls horizontal for a repeating page section and vertical for other page sections.
- Does not display the subset item, if one exists.
