Freeze and unfreeze data

As a data manager or CRA, you can prevent site users from editing case form data, to use it in data extracts and analysis. You can freeze data at a visit, form, and question level. Site users can only update a question after you unfreeze it.

You can freeze data for both complete and incomplete visits. All question types can be frozen, including instances of a repeating form, coding questions, and individual questions in question groups.

Note:

When an unfrozen question is updated and the change is submitted, the question automatically refreezes. This auto-refreeze action is attributed to the user who updated the data in the question's audit history.

When it comes to repeating forms, you can only freeze data in a repeating form instance when that form instance is completed.

If you or another user at a sponsor organization raises a query against a frozen question, that question remains frozen and the query can be answered by a site user. You can only unfreeze data at a question level, one by one.

Want to see how to perform this task? Watch the video below.

1. On the Home page, determine where to work:
   • To work with real data in Production mode, click the title of the study.
   • To work with mock data in Training mode, click the Training Mode button ( ) on the study.
2. Along the top of the page, select the Subjects tab.
3. If you have access to multiple sites for the study, select a site from the Site drop-down.
4. From the View drop-down, select Signed & Verified to filter your search for subjects whose data can be frozen.

   Tip:

   If you want to unfreeze data, select the Frozen option to filter your search for subjects whose data is already frozen.
5. Locate a subject in the table, and click a visit in the Previous Visit column.
6. Along the top of the page, click Freeze Data.
7. There are two ways for you to freeze data:
   • If you want to freeze all questions in a form, select the checkbox next to that form, on the right.
   • If you want to freeze a certain question, select the checkbox next to that question.
8. In the lower-right corner, click Freeze or Freeze & Close.
9. On the Freeze Data dialog, review the message, and click Freeze Data.
   If you don't want to freeze a subject's data, click Cancel.
10. If you want to unfreeze a question, click the menu icon () next to it and select Unfreeze. On the Unfreeze Question dialog, select an option from the Reason for Change drop-down and click Unfreeze.

All frozen forms and questions appear with the frozen icon () next to them. The same icon appears next to each subject if all of their data has been verified, as well as in the Answer & Visit History. What does each icon mean for signing, verifying, or freezing data?

Figure 5-2 How a data manager or CRA freezes data in a form