Lock of single forms

Lock the forms of an interim analysis or any form on its own; what a lock stops and what goes on; unlocking with a reason.

The data manager can lock a single saved form of a patient, or many forms at once, for example every clean form of the visits an interim analysis needs. Nobody changes the data of a locked form. The study-wide lock (the soft lock and the database lock) works as before; the lock of a form works next to it.

What a form lock does

The values of the form do not change: not from the browser, an import, the API, the patient's answers in ePRO or an approved ePRO correction. No file of the form is added or withdrawn.
Queries, SDV, the data manager's approval and the investigator's signatures go on as usual: they do not change the data.
A locked form has a lock mark in the patient card and on the form's page, with who locked it, when and why.
The data manager and the project administrator lock and unlock forms, until the database lock.

Lock one form

Open a saved form of a patient. On the right, in Form lock, write the reason if you like and press Lock the form.

Lock many forms

Open Form locks in the study menu.
Choose the visit, the form, the site or the patient, and which forms to take: clean (complete or SDV-verified, no open queries), approved by the data manager or all saved forms, drafts too.
Check the list, write the reason (for example “Interim analysis 1”) and press Lock. Every form the filter finds is locked, also the ones beyond the page.

Each lock is a record in the audit trail of its form. If the forms changed while you were looking at the list, the portal does nothing and asks you to check the list again.

Unlock

On the form's page write why the form is unlocked and press Unlock the form. Many forms are unlocked on the Locked tab of Form locks. The reason is required and goes into the audit trail. If a form is locked while the investigator fills it in, their save does not go through and they see a message about it.

Signature of a single form

A lock and a signature are different actions. When the study signs every form on its own (Signatures → Settings and signers → Every form), the investigator signs a form on its page. A signature does not lock the form, and a lock does not replace the signature. More in the article on the electronic signature.