How do I sign/unsign an input form?

Learn how to sign an input form, e.g. to confirm the accuracy of your information.

Signing

Once all required subject data has been entered and, depending on the set-up, a signature is required by your role for specific input forms, you can set it as follows.

The permission to sign a form does not depend on the fill-out status of a form, i.e. even when required fields are not completed or if there are open queries on the form, the form can be signed. The prerequisite for the signature, however, is that the signature has been set up in the form set-up. 

⭐ Good to know: 

If both locking and signing a form is required, you must lock the form before it can be signed.

Refer to the article on how to lock a form for details.

1.	Open the input form you wish to sign.
2.	At the top left, you will find the individual input forms under the study steps. Next to the name of the input form, you will find a small red pen symbol. Click on it.
3.	A small pop-up window opens. In this overview, you can see with which role you are signing, what the reason for the signature is, how many signatures are needed in total for this input form and what the current status of the signatures is. ⭐ Good to know: hierarchical signatures Signatures might be set up in a hierarchical order, requiring all previous signatures to be made before you can sign for your role within the hierarchy. If more than 1 role and signature is required without hierarchical order, you can – in general – sign anytime. To be able to set your signature, click on "Record signature". Important: In this example, only 1 (your) signature has been set up on the form (role All access).
4.	Another small pop-up window opens. When a signature is set, the following information is saved in the system: Name and role of the signee and reason for signature. You can enter an additional comment (if desired, not required per default). To be able to save your signature, enter the same password in the lower field that you enter when logging in. Then click on "Save".
5.	You will be redirected to the first pop-up window again. You can close this with the x-sign at the top right. Now, the pen in the input form turns green. This means that all required signatures have been made. Important: In this example, only 1 signature was required. Thus, the pen icon will turn from red to green as soon as it was made.

⭐ Good to know: 

The signature(s) column can display red, yellow or green pen icons. Same as with lockings, queries and (S)AEs the color reflects the lowest signature status if more than 1 forms are to be signed. A yellow pen means that at least one of the applicable forms has not yet been signed or that at least one of several signatures in a form is missing.

To check which form is pending signature(s) refer to step 2 below.

⭐ Good to know: 

The signature information adjusts to each visit (step) and form that you drill into via the dropdown (starting with "All steps") in the subject overview – same as with queries and lockings.

This means that you will see the pen icon with the applicable colour reflecting the signature(s) status depending on:

• the visit (step) and form level that you are at
• whether any forms within this step are included in signature procedures or not
• whether all or some or none of these forms were already signed and/or all required signatures within a form were made.

To view and access the forms that you wish to (un)lock:

1.	Open the subject overview of the study and click on the pen symbol for the respective subject in the signatures column.
2.	A small pop-up window opens. If you now click on the small arrow symbol next to the study steps, the individual input forms for this study step will open. Now click on the input form.
3.	As soon as you click on this button, you will be forwarded to the respective input form. Now you can carry out the steps described above.

Removing your signature(s)

As soon as data changes are made after the input form has been signed (e.g. due to incorrectly entered data etc.), all previously made signatures on this form are removed. The user entering the data will be asked to confirm that they wish to proceed with data changes and about the signature removal. Refer to our article on data entry for details: How do I enter data into Climedo?

If you wish to actively remove your signature on a form for other reasons, click on the green or yellow pencil in the applicable input form. In the electronic signature pop-up window, click on "delete my signature" (red button). It will be removed immediately and can be resigned as needed.

A signature can only be cancelled by the person who set it.

⭐ Good to know: hierarchical signatures

Removing a signature within the hierarchy order will automatically remove all of the following signatures (if made), but not the signatures located and made before yours.

You will have to sign again before the signatures placed after yours in the hierarchy can be resigned.

Bulk signature

If the Bulk Signature function is enabled in your study, you have the capability to sign input forms for up to five subjects. To do this, select the respective subjects in the subject overview and then click on "Sign Scheduled Events" located under the "Actions" section.

	At the top left you can select those steps or which you want to sign the input forms. By default, all steps are selected.
	Using this toggle, you can enter a comment for all or individual signatures , if required.
	When one or more forms are grayed out, as in this example, it means that they are not now available for signing. Typically, this indicates that a signature is still needed in the hierarchical structure (if applicable) or that these forms need to be locked (if applicable).
	Finally, input your Climedo system password. All signatures will be collected when you click "confirm".

⭐ Good to know

1. Queries can still be set and edited despite the signature (unlike with locking!). Read more about queries: How can I edit queries?; How do I manually create/close queries?
2. In general, you can have the option to sign (specific) ePRO forms if this has been set up in the study and ePRO form settings.
   1. This might be used for investigators to confirm the review of the ePRO completed by the subject.
   2. The signature does not prevent subjects from making changes after completing the questionnaire (unlike locking the form, see applicable article)
3. Only users with login access to Climedo can sign forms as per set up. Subjects cannot sign their own ePRO forms!
4. (S)AE forms, unscheduled forms and samples forms can be signed if the forms were set up accordingly, including a hierarchical order.
5. If both locking and signing are required in an input form, the form always needs to be locked first before it can be signed. If an input form is unlocked again, this does not result in the signature being removed.

Video

As an investigator, you may need to sign multiple input forms for different subjects in the system. With just a few clicks, you can sign all or individual input forms for up to five subjects in one go. However, please note that this function needs to be activated in the settings. If it is not available to you, please speak to your monitor. Please note that this function is available for (S)AE signatures as well.