Study Definition module

 

Changing a study once it is open for subject data entry

Once the study status is Open, indicating that you are now collecting live data, only limited changes may be made to the study definition to ensure that the subject data remains valid.

 

If you enter subject data and then change the study definition, you may invalidate the existing subject data. In some cases you will no longer be able to open the subjects in the Data Entry module.

 

If you suspect that a study contains corrupt data you can use the Study Data Diagnostic Utility (SDDU) to identify any invalid data. Help on this..

 

If you need to make changes to an open study, we strongly recommend that you make a copy of the study definition first. Note that importing this copy at a later stage would overwrite the existing one and would invalidate any subject data entered since the backup was taken.

Changes that can be made to a live study

Changes that cannot be made to a live study

 

When the study status is In preparation, you can make any changes you like to the study definition, although you may not always be able to re-open your earlier study subjects in Data Entry.

 

 

Related Topics

Changing the status of a study

Checking the validity of subject data

Copying a study