Enhancements to Subject Data Extract with visit data

A new dataset, VISIT_SYS, has been added to the Subject Data Extract to consolidate visit information, making user review, reporting, and analysis easier and more efficient.

The VISIT_SYS dataset provides Data Managers and Statisticians with a consolidated view of all visits across all subjects. Centralizing visit data in one place can speed up the post processing time for analysis and the Study Data Tabulation Model (SDTM) standard by providing current visit statuses, dates, details, disposition terms, or reasons for specific actions. This approach enhances programming accuracy and accelerates SDTM dataset creation, leading to more efficient development timelines and enabling clinical trial data to be quickly prepared, organized, and submitted for compliance, analysis, and reporting.

The Subject Data Extract now includes a new dataset, VISIT_SYS, which contains the following new fields VISSTAT, SKIPYN, DSDECOD, DSSTDAT, and REASON, that are only present in this dataset.

New data fields

New data field Description
VISSTAT
Indicates the visit status. The following statuses are available:
  • INPROGRESS
  • INCOMPLETE
  • INCOMPLETE_ERROR
  • COMPLETE
  • COMPLETE_ERROR
  • NOT_STARTED

For more information about the visit statuses, see Visit status and icon descriptions
SKIPYN
Indicates if a visit is skipped. The following values are available:
  • Y for visits that were skipped.
  • N for visits that were not skipped.
DSDECOD Indicates the Disposition Term. The following values are available:
  • Screened
  • Screen Failure
  • Randomized
  • Completed
  • Withdrawal

For more information about the subject statuses, see Available subject statuses.

DSSTDAT Indicates the Disposition Date for the corresponding event, following the YYYY-MM-DD format.
REASON Indicates the Reason for a specific action, such as a skipped visit or withdrawal.

The Adverse Event event will not be included in the new dataset since it does not include a visit date.

You can find additional information about this feature in the Reporting Guide, after the Release Assessment Environment (RAE) upgrade.

Parent topic: Reports, archives, and analytics