Guided Site Workflow With Automatic Action Item Generation

No two research organizations do things exactly the same, especially when it comes to workflow. Clinical Studio allows you to define the Case Report Form life cycle and the order that events occur. The life cycle consists of:

  • Data Entered into form and saved
  • Form Cleaned of data entry errors and all queries resolved (green check status)
  • Form Reviewed (forms can be reviewed by up to five different users and locked after each review level)
  • Form Locked (Reviews; Data Manager, Monitor, Investigator, etc.)
  • Form Electronically Signed

In addition, all form states must be made temporary. Users will need to unlock forms and make changes under special circumstances. Site reviews usually require that forms be “frozen” prior to a site visit. Electronic signatures must be placed on forms. Forms must be source verified at either the form or individual field level. Clinical Studio allows you to configure any or all of this and the order that events occur into a comprehensive work flow strategy.

define review levels and order in clinical trials
Define Review Levels and Order