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 subject, visit, form, and question level 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 it comes to repeating forms, you can only freeze data in a repeating form instance when that form instance is started and incomplete.

Any newly added or restored repeating form after the visit or subject is frozen results in the visit or subject updating to a status of Never Frozen.

If you or another sponsor user raise a query against a frozen question, that question remains frozen but the query can be answered by a site user at any time. However, site users can only update the question after you unfreeze it. You can unfreeze data at any level, Subject, Visit, Form and Question level, all at once.

Note:

When data is unfrozen, the data dose not auto-refreeze at any level (Subject, Visit, Form, Question). Additionally, in previously frozen subjects and visits, if a question is unfrozen in a visit, the form, visit and subject status moves to Unfrozen until the question is refrozen.

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

  1. Access your study in a specific mode.
  2. Along the top, make sure Subjects is selected, and that you're on the Subject Overview view.
  3. If you have access to multiple sites for the study, select a site from the Site drop-down.

    Tip:

    • From the Review drop-down, select Signed & Verified to filter your search for subjects whose data can be frozen.
    • If you want to unfreeze data, select the Frozen option to filter your search for subjects whose data is already frozen.
  4. Locate a subject on the subjects list, and select a visit from the Previous Visit column.
  5. Along the top of the page, select Freeze Data.
  6. There are two ways for you to freeze data:
    • To freeze all questions in a form, select the checkbox next to that form's name, on the Forms sidebar, on the left.
    • To freeze a specific question, select the checkbox next to that question.
  7. In the lower-right corner, select Freeze or Freeze & Close.
  8. On the Freeze Data dialog, review the message, and select Freeze Data.
    If you don't want to freeze a subject's data, select Cancel.
  9. To unfreeze a question:
    This is applicable only for frozen questions.
    1. Select Menu Menu next to it.
    2. Select Unfreeze.
    3. On the Unfreeze Question dialog, select an option from the Reason for Change drop-down.
    4. Select Unfreeze.

All frozen forms and questions appear with the Frozen icon Frozen next to them. The same icon displays for a given subject if all of their data has been verified.

All unfrozen forms and questions appear with the Unfrozen icon Unfrozen next to them.

Parent topic: Sign, verify, freeze, and lock data