Full Auditing

Activity Audit

Clinical Studio tracks every action made by each user and stores navigation, user, site, time, application and session variables for each transaction in the database.

Subject Record Audit

All data being entered, updated, or deleted from any CRF is audited by the system. The audit tracks the following:

  • Date of transaction
  • Type of transaction (insert, update, delete)
  • Subject
  • Site
  • Form
  • Field
  • Table ID
  • Table Row
  • Old Value
  • New Value
  • Reason for Change
subject record audits in clinical trials
Subject Record Audit

Case Report Form Status Diary

Every transaction done to a given case report form – whether it be saved, saved with errors, reviewed, frozen, locked or unlocked – is stored along with the user that made the change and the exact time the status changed. A report is available that displays all status changes for each CRF and allows that information to be filtered and searched.