Study-specific clinical package

The study-specific clinical package provides access to both clinical and study management data. It consists of report topics and report elements from both the clinical and Trial Management data models.

Note: Use the study-specific package to create reports that include clinical data. Because clinical data is unique to each study, report definitions using the study-specific package might not be validated to work across different studies.

A clinical package groups data in each report topic into four sub-folders: Basic Data, Additional Data, Incomplete Data Reasons, and Internal IDs.