How do I set up the signature function for an input form? (Step 3)

Learn how to edit the signature function, for example, to confirm the correctness of data entry.

Important note: Currently all signatures are possible on input form level. If you like to give the possibility of signing a whole patient, we recommend to set up an extra input form for a signature which is set up at the end of the study workflow. On this signature input form should be a confirmation of the site for completion of the patient and understanding of this "overall" signature.

Step 1:

1. After logging into the system, click on the study module.
2. Choose the study you would like to edit. Click on the "Settings"-button.

Step 2:

1. The editing mode of your study opens. Now click on step 3 for the "3. Forms".
2. Click on the tab "Scheduled Event Forms" and the input form you want to edit or on "Create new form". You can add the signature function both during the initial set up when creating a form or add it later. For setting up a signature on the (S)AE input form, please follow the tab "(S)AE Forms". The set up here is equal to every other input form.

Step 3:

1. When setting the toggle for “Signatures required” the menu “Signatures setup” appears. 

2. Click on "Add signature role". 

   
   
   

3. A small box appears. Here you define in the first column which role(s) shall sign this input form. You can add any number of roles by clicking "Add signature role". Make sure, however, that you also assign the right to sign to this role in the role configuration under "data verification" for Scheduled Event Forms and/or "(S)AE" for (S)AE Forms. Only roles with signature rights will be available in the drop down. Read more about role configuration here: How can I set up user roles? In the second column, you can either use one of the three predefined texts (authorship, review or approval/release) as the reason for signature or simply overwrite it with a customised text. In the last column, you specify how many signatures (up to 5) are required by this role on this form. Per default "1" is set.

   1. Each user can only sign once. If you set up 2 signatures for the role "Investigator", e.g. for a double confirmation of correct inclusion/exclusion criteria, 2 users with this role must be present to sign each. Both signatures are needed to achieve the status fully signed (green icon).

      

4. In addition, you can set the signatures setup to arrange the signatures in a hierarchical order. To do this, you must switch on the toggle at the bottom right of the screenshot. With this function, you can determine which role has to sign first to allow the signature(s) of the next role(s) and in which order. As you can see in the screenshot, you cannot specify a quantity of signatures with this setting. If several people should sign with the same role (see example 3.a), we recommend that you add the role multiple times to enable a hierarchical arrangement.

5. The signature function is irrespective of whether the fields in the form are set to required or not. Incomplete forms can be signed. Further data entry or data changes will automatically remove all signatures on that form.

⭐ Fun facts:

1. You can set signatures on forms that will be added to an ePRO scheduled event, e.g. for an investigator to sign and confirm his/her assessment of an ePRO completed by the subject. The subject does not have or see the option to sign the ePRO form(s).
2. If you combine (hierarchical) signature function with the locking function, the form(s) will have to be locked first to allow signing. A role can both lock and sign a form. Read more about the locking function here: How do I create the locking function for an input form?
3. The actual signing takes place on the respective input forms within the scheduled events of each subject. You can see the signature status in the subject overview or in the individual input forms during data entry. Find more details on this in the following article: How do I sign/unsign an input form?
4. It can be very useful to use our "bulk signature" feature in stressful everyday site life. Read more  in the following article: How do I create and edit a study workflow (Step 4)

Workaround: 

If you want to sign the whole patient instead of all input forms individually, we propose the following workaround: You create an additional input form as last form in the last study step which could be called "Final eSignature" and insert a rich text with the confirmation text into this input form. Don't forget to set the signing function here.