Overview: Freezing and locking
Freezing and locking data enables you to prevent changes in forms, either temporarily during a trial or permanently at the end of a trial.
You can freeze and lock:
- Forms
- Visits
- Case Books
Note: You can freeze or lock only a form in which a user has entered at least one data item or comment. If you freeze or lock a Case Book, freeze or lock icons appear only on started forms; however, all forms in the Case Book are frozen or locked. The activities that are allowed or not allowed, as listed in the following table, pertain to all forms.
When you freeze or lock a form or Case Book, the following rules are in place:
Activity allowed? |
CRF frozen |
Case Book frozen |
CRF locked |
Case Book locked |
---|---|---|---|---|
Add/update patient data |
No unless allowed.* |
No, unless allowed.* |
No. |
No. |
Add/update comments |
No unless allowed.* |
No, unless allowed.* |
No. |
No. |
Open queries |
No unless allowed.* |
No unless allowed.* |
No. |
No. |
Answer queries |
Yes, but can change data value only if allowed.* |
Yes, but can change data value only if allowed.* |
No. |
No. |
Close queries |
No unless allowed.* |
No unless allowed.* |
No. |
No. |
Mark SV ready |
Yes. |
Yes. |
No. |
No. |
Source verify |
No unless allowed.* |
No unless allowed.* |
No. |
No. |
Sign CRF |
Yes. |
Yes. |
Yes. |
Yes. |
Sign case book |
Yes. |
Yes. |
Yes. |
Yes. |
*Sponsor users can perform this activity only if the trial has been configured to allow sponsor users to update forms after they are frozen. |