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When you freeze or lock a form or case report book, the following rules are in place:
Rules for freezing and locking
|
Activity allowed? |
Frozen CRF |
Frozen case report book |
Locked CRF |
Locked case report book |
|---|---|---|---|---|
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Add/update subject data |
No unless allowed.* |
No unless allowed.* |
No |
No |
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Add/update comments |
No unless allowed.* |
No unless allowed.* |
No |
No |
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Open queries |
No unless allowed.* |
No unless allowed.* |
No |
No |
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Answer queries |
Yes, but can only change data value only if allowed.* |
Yes, but can only change data value only if allowed.* |
No |
No |
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Close queries |
No unless allowed.* |
No unless allowed.* |
No |
No |
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Mark SV ready |
Yes |
Yes |
No |
No |
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Source verify |
No unless allowed.* |
No unless allowed.* |
No |
No |
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Sign CRF |
Yes |
Yes |
Yes |
Yes |
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Sign case report book |
Yes |
Yes |
Yes |
Yes |
* Sponsor users can perform this activity only if the study has been configured to allow sponsor users to update forms after they are frozen.
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