Safety Case Folder

This table describes the data elements included in the Safety Case folder.

Data Element Description
ACCEPTANCE_TIMESTAMP Timestamp of the latest transition to accepted status of an accepted safety case. This is populated only for accepted subject safety case rows. Non-accepted rows return blank.
CASE_ID Identifier of the safety case in Clinical One Cloud Service.
CASE_LABEL Safety case label associated with the subject safety case row.
CASE_STATE
Case state derived from the as-of submitted-row count for the safety case row. Possible values are:
  • INITIAL
  • FOLLOWUP

Note: This is blank before the first submission.

CASE_STATUS Current safety case status displayed consistently with Clinical One Cloud Service. Possible values are:
  • Not Submitted
  • Submitted
  • Transfer Failed
  • Canceled
  • Accepted
  • Rejected
  • Dismissed
CREATION_TIMESTAMP Source timestamp of the subject safety case record creation.
SAFETY_CASE_ID Safety case identifier loaded into Data Hub.
SAFETY_COMMENT Safety comment captured for the subject safety case.
SUBMISSION_COUNT Submission count derived from loaded safety case source data.