Summary

This article covers Study Audit Settings

The audit settings dictate how the system tracks changes to study data. To access, open the Study Configuration page and select the Audit tab. Read below the image for a description of each setting.



  1. Audit Changes to Subject CRF data - This tells the system to track data changes on all subject forms.

  2. Require reason for any change - When data is changed on an existing subject record, the system will ask the user to provide a reason for changing the data. These reasons can be pre-set and required, as explained in the next few options.

  3. Use coded instead of free text field for the reason - If this is checked, when reasons are provided for changing data, it will force the user to use the pre-set options. This makes data management a little easier.

  4. Allow first reason to be inserted for all other reasons - If several data changes are made on the same record, this option allows (but does not force) the user to enter the same reason for all the changes with one click, rather than going through and providing a reason for each individual field.

  5. Change Reason Coding - Allows the study designer to provide pre-set reasons for changing data. This may be forced on users or it can be made optional (see #3 above).

Note: Changes cannot be made to these options after subjects exist in the study. If you are merely testing your study with test subjects, either clear all data from the Study Configuration page, or copy the study to start new.



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