Subject Safety Case dataset

You can use the Subject Safety Case dataset to report on subject safety cases across studies to monitor submissions, track case status, and support timely Safety reporting.

Modes

Available in all 3 modes: Testing, Training, and Production

What type of data can I include in a custom report or visualization on Safety Cases?

With this dataset, you can get custom data such as:

  • Monitor safety case submission and processing status.
  • Track initial and follow-up safety cases.
  • Identify rejected cases and review associated comments or rejection reasons.
  • Monitor timely safety case reporting across sites.
  • Review a complete audit history of safety case activity.

For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.

Browse descriptions of data elements included in this dataset:

Note:

Blank columns in Oracle Clinical One Analytics indicate null or not applicable.

Parent topic: Dataset descriptions