Hands Off My Data – Database Locking  

Soft Lock vs Hard Lock  

What is a database lock?  

Locking the database (i.e., locking forms in the study) makes forms un-editable. Locking can be flexible, can be done at a variety of scales, and can be reversed (i.e., unlocked) should a temporary lock be needed. When forms are locked, not only can they not be changed, but they can no longer be electronically signed and form adjuncts, such as queries and comments, are not available to users. 

 

Why is it needed?

 There are multiple reasons why a user would elect to lock forms: 

  • There was protocol deviation and study personnel decided to lock relevant forms while they are investigating the deviation and determining the impact on the study.          
  • A site has been “fired” or has opted to no longer participate in the study.  
  • The study has been completed and the database is ready for statistical analysis. In this case, it is important to ensure that no further database changes are made.

Soft Lock vs Hard Lock   

Soft Lock  

A soft lock can be temporary and done during study conduct. This provides flexibility when a lock is needed but might need to be unlocked in the future. For example, a site’s participation in the study must be paused due to an unforeseen circumstance. 

A full database soft lock is performed before a hard lock. However, some monitors prefer to lock individual forms as they are finalized before the end of the study. This way they can be confident that no further changes have been made to those forms. 

Hard Lock  

A hard lock is permanent and is done in conjunction with study closeout. The only time a hard lock should be implemented is when forms have been reviewed and finalized. 

Before initiating a hard lock, all forms must have been previously soft locked. Form permissions are then changed so that users no longer have permission to lock and unlock forms and no longer have permission to add subjects and sites. 

The Bottom Line   

The main difference between the two is that a soft lock can be temporary and performed during a study, and a hard lock is permanent and performed at the end of a study.  

During the hard lock, permissions to lock and unlock forms are removed, along with permissions to add new subjects and sites. While, technically, this configuration change can be undone if absolutely necessary, it is performed in a way that monitors can rest easy knowing that the study is reviewed, finalized, and cannot be edited in any way. 

Interested in Prelude’s database locking features? Contact Us.