Data Entry/Review module

Revalidating subjects

To revalidate all subjects, you need both the 'Access Batch Validation' and 'Change data' permissions

You can carry out basic revalidation of single or multiple subjects from the DE/DR module but for anything more complex, it is better to use the Batch Validation module.
Compare validation options in the two modules

What is validation?

Questions are automatically validated every time that an eForm is opened by a user with the Change Data permission and every time that an eForm is saved. Any question validation conditions and 'collect if' conditions are run, and all derived values are calculated. All changes are saved to the database, just as if you had opened and saved each eForm.

Revalidation allows you to run validation on all or selected eForms for a subject or group of subjects without having to open each individual subject.

The Batch Validation option on the Tools menu is only available when the full Subject List is open (accessed via the Subject List toolbar button/menu option or via the search panel). It is not available when the schedule is open for a subject.

Revalidating multiple subjects

Please note that this option will revalidate all subjects displayed on the current page only and not any subjects on further pages. You need the 'Access Batch Validation' permission to revalidate multiple subjects.

1. Open the full Subject List or the Data Browser. Help on this

   Opening the Subject List

   1. Open the full Subject List, either via the toolbar button/menu option or via the search panel.

   Opening the Data Browser

   1. Select View > Search Panel or click the Open Search Panel icon to open the search panel. General help on using the search panel

      • When you open the search panel, it will appear as it was when the panel was last closed.

      • At any time you can clear all the search fields by clicking the Clear Search fields icon at the top of the panel.

      • To save a search for future use, click the Save Search icon at the top of the panel to save the current combination of search settings. Enter a name for the new search or click Replace Search and select a search to overwrite. Click Save. Searches are stored separately for each user. To open a previously stored search, click the arrow to the right of the Open Stored Search icon at the top of the panel and select a search from the drop down list.

   2. Leave Data selected in the drop down list at the top.

   3. Set the Search Detail Level to Subject and select the statuses that you wish to search on plus any other information. Help on each field within the search panel

      Search Detail Level

      Detail

      Select the level of detail to which you want to see data.

      General

      Study	If you are permitted access to data from more than one study, you can choose to view data from all studies, or from a particular study only. Select your choice from the drop down list.
      Site	If you are permitted access to data from more than one site, you can choose to view data from all sites, or from a particular site only. Select your choice from the drop down list.
      Subject	You can choose to view data entered for a particular subject only, by entering the subject label (part or whole), or the subject ID. The subject list will open, containing only those subjects who fit your search criteria.

      Statuses

      Select/Clear All	Use this toggle to either check all the status boxes or to clear all checks. Hover over a status icon to see the status label as a tooltip.
      status	Click these check boxes to include all questions with a particular status or combination of statuses. You can select multiple check boxes.
      Comments	You can choose to disregard comments (blank) or only include questions with no comments attached (None) or only include questions with comments attached (All). Select your choice from the drop down list.
      Notes	You can choose to disregard notes (blank) or only include questions with no notes attached (None) or only include questions with notes attached (All). Select your choice from the drop down list.

      DCRs/SDV Status

      DCR	Select a status from the list to include questions with DCRs of that status. The statuses are raised, responded, closed, printed or received. This section is only available if your user permissions allow you access to DCR data.
      SDV	Select a status from the list to include questions with SDV marks of that status. The statuses are planned, queried, done or cancelled. This section is only available if your user permissions allow you access to SDV data.

      Study Level

      Visit	You can include data from all visits, or from a particular visit only. Select your choice from the drop down list.
      eForm	You can include data from all eForms, or from a particular eForm only. Select your choice from the drop down list. This list will only contain eForms available in the selected visit.
      Question	You can include data from a particular question only. Select your choice from the drop down list. This list will only contain questions available in the selected visit/eForm combination.

      User

      User	You can include data entered by all users, or by a particular user only. To specify a particular user, select the name from the drop down list.

      Date Range

      Search	You can search for data before or after a certain date, during a certain period or with no date restrictions. Select your choice from the drop down list.
      From	Enter the date from which you want to search by clicking the arrow and selecting the date form the popup calendar.
      To	Enter the date to which you want to search by clicking the arrow and selecting the date form the popup calendar.

      Clinical Coding

      Type	You can choose to view thesaurus questions associated with all MedDRA dictionaries, or from a particular dictionary only. Select your choice from the drop down list.
      Statuses	You can choose to view thesaurus questions with a specific coding status. Select your choice from the drop down list.

   4. Click the Execute search buttonto display the data in the Data Browser in the main window.

   5. Multi-select the subjects that you want to revalidate. If you want to revalidate all subjects in the current study you can do it from here but it is easier to do it from the Subject List.

    

2. Select Tools > Batch Validation.

3. Specify the type of revalidation report that you wish to run. Help on options

   Validate only selected subjects	This option is not available in the Subject List as you are revalidating all subjects displayed on the current page. To revalidate selected subjects, use the Data Browser method.
   Save revalidation changes	Check this box to save to the database all changes caused by the revalidation. Leave the box unchecked to view the changes in the revalidation report but not to save 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.
   Create verbose report	Check this box to include all data in the revalidation report. Leave the box unchecked to include only changed data in the report.
   Single eForm only	Check this box to run revalidation on a single eForm only for the subjects in the list. Select the eForm from the drop down list. Leave the box unchecked to revalidate all eForms.

4. Click Revalidate and click OK to confirm.

5. To cancel the revalidation during the process, click Cancel. Revalidation will be completed for the current subject and then the process will stop.

6. The revalidation report is displayed and if you have chosen to save changes, they will be saved to the database.

7. Click Save As... to save the report as a .txt file to a specified location.

Revalidating a single subject

1. Open the schedule for a subject.

2. Right click on the subject status icon at the top left of the schedule and select Revalidate subject... from the popup menu.

3. Specify the type of revalidation report that you wish to run. Help on options

   Save Changes

   Check this box to save to the database all revalidation changes since the last validation. Leave the box unchecked to view the changes in the revalidation report but not to save 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 are saved to the subject schedules regardless of whether you choose to save changes.

   Verbose report

   Check this box to include all data in the revalidation report. Leave the box unchecked to include only changed data in the report.

4. Click Revalidate and click OK to confirm.

5. To cancel the revalidation during the process, click Cancel. Revalidation will be completed for the current subject and then the process will stop.

6. The revalidation report is displayed and if you have chosen to save changes, they will be saved to the database.

7. Click Save As... to save the report as a .txt file to a specified location.

When revalidation cannot be carried out

• When a subject is frozen or locked

• When an eForm is frozen, locked or unobtainable

• When the study definition is open for editing

• When the current user does not have both the 'Access Batch Validation' and 'Change data' permissions

Related Topics

About question validation

The Batch Validation module