Locking freezes data. Signing puts a named person's electronic signature on it. They are separate permissions, separate actions, and they do not cover the same scope, so it is worth being clear about which one you are doing.
š Prerequisite: eCRF Records (Lock) and eCRF Records (Sign) are two different toggles on your role, so you may have one and not the other. Every query on a form must be closed before that form can be locked.
What you can lock, and what you can sign
Sign has a narrower scope than Lock. There is no sign control at form level. In the eCRF, a visit is a section and a form is a sub-section.
Action | Applies to |
Lock | A form, a visit, a whole eCRF, or several eCRFs at once |
Sign | A visit, a whole eCRF, or several eCRFs at once |
Lock data
š ļø Step by step guide
Open the subject's eCRF.
Find the form in the left panel, or the visit name above it.
Select the padlock control on that row.
ā ļø Warning: locking fails outright if the form holds a query that is not closed. Datacapt shows Failed to lock form, please close queries first. Resolved is not enough: the query has to be closed. Work the Queries dashboard down to zero before a database lock, or you will hit this one form at a time. See Raise, answer and close a query.
What changes once a form is locked
Less than most people expect, and the differences matter.
Action | After locking |
Reading the form | Unchanged. Anyone with access can still open and read it. |
The eCRF status and completion percentage | Unchanged. Locking is not a status. |
Changing an answer | Blocked |
Raising a new query | Blocked |
Declaring missing data | Blocked |
Marking data as SDV | Still possible |
Viewing the audit trail | Still possible |
A blue banner appears at the top of the form reading Form was locked on [date] at [time] by [name], so anyone opening it can see who froze it and when.
š” Tip: the quickest way to see what a lock blocks is the Ā·Ā·Ā· menu on any question inside a locked form. It keeps Add SDV and Audit trails, and everything else is gone. Locked forms also show a green closed padlock in the left panel and in the Visit (Event) view of the Inclusions list.
Sign data
Signing is an attestation, so it asks you to confirm your identity.
š ļø Step by step guide
Open the subject's eCRF.
Select the signature control beside the visit name, or use the Inclusions list for several eCRFs at once.
Select the forms to sign.
Tick the declaration box.
Select Submit.
Enter your password. If you sign in through SSO, select your account instead.
Confirm.
ā ļø Warning: only the person who signed can un-sign. Nobody else can undo it, whatever their permissions. If a signer leaves your organization mid-study, anything they signed stays signed. Take that into account when you decide who signs, and when. The Inclusions list action bar does offer Unsign on a selection of subjects, but the same rule applies to each one.
Act on several subjects at once
Locking or signing subject by subject does not scale at database lock. The Inclusions list does all of it in one gesture.
š ļø Step by step guide
Open the study and go to the Inclusions list, List tab.
Tick the subjects you want. Use the checkbox in the header row to select every subject at once.
An action bar appears at the bottom of the screen, showing how many are selected.
Select the action you need: Export, Lock, Unlock, Sign or Unsign.
š” Tips
Each row is one subject's whole eCRF, so a bulk action here applies to the entire eCRF, not to a single visit or form.
Export in this bar exports only the subjects you selected. That is different from Export all at the top of the page, which exports the whole database. Use the selection when a statistician asks for one center or one cohort.
The bar also holds Unlock and Unsign, so a bulk action taken by mistake can be undone the same way.
Unlock
Unlocking is what you do when a query needs raising, or an answer needs correcting, on data that has already been frozen. Both are blocked while the lock is in place, so the sequence is unlock, fix, lock again.
The control has a different name depending on where you are, which is worth knowing before you go looking for it.
Where | The control reads |
Inside a locked form, on the blue banner | Remove |
In the Inclusions list, with subjects selected | Unlock |
š ļø Step by step guide
One form
Open the subject's eCRF and go to the locked form.
Find the blue Form was locked onā¦ banner at the top.
Select Remove on the right of the banner.
One or more whole eCRFs
Go to the Inclusions list.
Tick the subjects.
Select Unlock in the action bar.