Selecting revalidation options

By default, the batch validation log file lists all visit and eForm details for each subject being revalidated whether or not any changes have been made as a result of the revalidation process. If you wish to see only those eForms for which changes have been made, select the Log Changes only checkbox.

Revalidating a single eForm only

If you select the Single eForm only checkbox, the eForm list in the upper half of the screen becomes available, containing all eForms in the selected study. Use this eForm list if you only want to revalidate a particular eForm for the selected subjects.

Choosing whether or not to save changes

Leave the Save changes checkbox selected to save all changes resulting from revalidation to the MACRO database. If you do not want changes saved, uncheck the box. Changes will still be reported in the validation log file but will not be saved to the MACRO database. This enables you to view the changes that revalidation will cause before committing to them.

Please note that if you add new visits or eForms to a study definition and then revalidate existing subjects, any new visit and eForm instances (but not the question responses) are saved to the subject schedules regardless of whether you choose to save changes.

Creating a CSV output file

If you select the CSV output checkbox, a CSV file will be created in addition to the log file.

The CSV file only reports the changes that have occurred during batch validation. If no changes occur, the file will contain only a header row, regardless of whether or not you have selected 'Log changes only' (as this option only affects the content of the log file). So, for a particular subject, if no changes occur and there is no automatic unfreezing/unlocking, no entries will appear in the CSV file for that subject.

The CSV file will have the same name as the log file you have specified, but with ‘_csv’ added to the file name and with an extension of ‘.csv’.

Automatically unfreezing/unlocking data

Batch validation cannot be carried out on frozen or locked data. You can temporarily unfreeze/unlock data by selecting the Auto Unfreeze and/or Auto Unlock check boxes. This will unfreeze/unlock any data which is already frozen/locked.

To automatically refreeze/relock the data again after batch validation has run, leave the Auto Refreeze and/or Auto Relock check boxes selected. This will ensure that the freeze/lock status of all data is reset to how it was before the revalidation.

Please note that if you uncheck the Auto Refreeze/Relock options, data will remain unfrozen/unlocked after the revalidation process has completed and there will be no way of automatically refreezing/relocking it at a later date. You would need to perform this task manually using information from the BV log file or the Freeze/Lock audit trail (accessed via the Freeze/Lock History version of the Search panel in the Data Entry module).

As automatic unfreezing and unlocking are complex actions, selecting them may slow the overall batch validation process.

Click here for more help on the behaviour and consequences of auto freezing/locking.

· If Auto Unfreeze and Auto Unlock are both selected, an object which is both frozen and locked is automatically unlocked and unfrozen. However, if Auto Unlock is selected but not Auto Unfreeze, an object which is both frozen and locked is automatically unlocked but remains frozen, and so will not be revalidated.

· A locked object cannot be unfrozen, so if Auto Unfreeze is selected but not Auto Unlock, an object which is both frozen and locked remains locked, and so will not be revalidated.

· If the Single eForm option has been selected, and Auto Freeze/Lock options have been selected, the subject is unlocked/unfrozen as necessary, but automatic unlock/unfreeze is only applied to those visits which contain an instance of the selected eForm.

· Auto Refreeze and Auto Relock have no effect on objects which were not automatically unfrozen or unlocked, except for new instances of objects as described below.

1.5.2 New objects

If new instances of visits, eForms or responses are generated during Batch Validation with Auto Freeze/Lock options selected, they will acquire the freeze/lock status of their parent object.

For example, if new responses are created on an eForm (because new questions have been added to the study definition), and the eForm has been automatically unfrozen, at the end of revalidation the new responses will be frozen (because the eForm is refrozen).

Similarly if new eForm instances are created in a frozen visit, the new (blank) eForm instances will end up as frozen within the visit.

Note that if new visits or eForms have been added to the study definition, new visit/eForm instances will be added to a subject during revalidation if it is unlocked, and these are saved even without "Save changes" being selected. New visit and new eForm instances are not recorded in the BV log file.

If new questions have been added to the study definition, new question responses are only added if the corresponding eForm is unlocked, and new responses are only saved if Save Changes is selected. New responses are recorded in the BV log file.

1.5.3 Permissions

The Auto Unfreeze/Refreeze options are only available if the current user has a role which includes all of the eight 'Unfreeze' and 'Freeze' data permissions, i.e. Unfreeze at subject level, Unfreeze at visit level, Unfreeze at eForm level, Unfreeze at question level, Freeze at question level, Freeze at eForm level, Freeze at visit level, Freeze at subject level.

Likewise, the Auto Unlock/Relock options are only available if the current user has a role which includes all of the eight 'Unlock' and 'Lock' data permissions.

1.5.4 Audit trail

All automatic freeze/lock operations are recorded in:

The BV log file
The CSV file if the 'CSV output' option is selected
The Freeze/Lock audit trail (accessed via the Freeze/Lock History version of the Search panel in the Data Entry module).