Signing data

  • Updated
  • Published by Viedoc System 2026-11-03
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Introduction

The Investigator signs the data. Signing for a subject can be done on an individual form, event, or across a study either using the signing console on the Details page, or if your role has the Batch sign permission, you can sign multiple forms using the Batch view on the Selection page.

Signature definition

This content is shared by the lessons in the following user guides

Admin: "Managing users (for Org Admin)"

Monitors & Project Managers: "Managing users"

Clinic: Signing data

The Study Manager should, in cooperation with the Site Manager(s), ensure that all users of Viedoc are informed, and certify that all electronic signatures created in the system are intended to be the legally binding equivalent of a traditional handwritten signature.

In Viedoc, the purpose/meaning of a signature is always “responsibility” as used in Sec. 11.50 of Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) part 11. The signer is thereby acknowledging his/her responsibility for the entered data. Viedoc keeps account of what was signed, who signed it, and when the signature was performed.

Signing console

To access the signing console, go to the Details page and select SIGN:

The signing console opens:

The signing console lists all of the initiated forms with no issues for the selected subject, grouped by event.

You can use the filter in the top of the page to:

  • Show all forms
  • Show only unsigned forms

The eye icons help you identify which forms you have visited (the most recent version of the form):

  • The green eye icon means that you have viewed the last version of the form.
  • The grey eye icon means that you have not viewed the latest version of the form.

To review a form, select the form bar. Closing the form takes you back to the signing console.

To view the review status of:

  • CRA - reviewed by Clinical Research Associate (CRA) or another role with review permission
  • DM - reviewed by Data Manager (DM) or another role with review permission
  • SDV - performed Source Data Verification (SDV)

...for each form, check the Show review status checkbox in the top right corner of the page.

To sign the data:

1 Select the form(s) to be signed in one of the following ways:
  • To sign one form at a time, select the sign icon to the right of the respective form:
  • To sign all unsigned forms within an event, select Sign all? to the right of the respective event:
  • To sign all unsigned forms for the respective subject, select Sign all? at the top of the page:
2

Select Ready on the top bar of the page. A confirmation pop-up appears:







The text explains the default meaning of the signature in Viedoc when an Investigator signs data. This is a generic text meant to cover all of the regulations under which any study is conducted. The regulations are different according to the study. The Study Manager/Study Coordinator (or anyone responsible for the study site) is responsible for informing the Investigator about the regulations.
3

Type in your password and select Confirm.

Important! If you enter an incorrect password three times in a row, your account will be locked.

Note! For scheduled and unscheduled events, the event date form ($EVENT) still counts, even when it is excluded when you use automatic event dates.

  • In the signing console, the counter (number of forms) for a event includes the $EVENT form. This cannot be selected to be signed but can be signed if you select Sign all (for subject or event).

If you sign forms on an event individually, you will not be able to sign the $EVENT form. As a result, the sign symbol for the event is not visible, even though it looks as though all forms have been signed.

Batch sign

If you have the Batch sign permission configured for your role in Viedoc Designer, when you select Launch for your study, the Batch view opens from the Selection page.

Note! Any user role with access to the study can open the Batch view, even without the Batch sign permission. Without that permission, the view is read-only: selection checkboxes, select all, and Sign are not available, although you can still search, sort, and open a form.

The Batch view shows:

  • All subjects for one or more sites, depending on your site access
  • Forms grouped by subjects and by subject and event.

You can also search the Batch view by subject or by form title. Use the dropdown in the search field to select the search type.

Note!

  • If the Event date form is hidden in the study design, it is not visible in the Batch view, and is not signed when all forms are signed.
  • If the Event date form is shown in the study design, the event date is shown in the Batch view under the Forms column, next to the Event date form name under the subject's event.
  • In the Batch view, the Event date form row does not show a Viewed or Not viewed icon. The Event date form is counted as viewed when signing, even if you have not opened it.

For each subject, you can:

  • Expand the row to view the forms available for signing
  • Open a form from the batch view and then close the form to return to the batch view.

The following columns are available in the batch view, so you can see which forms are ready for signing:

  • Subjects and Forms - all forms available for signing listed by the subject's ID.
  • Signed - whether the form has been signed.
  • Viewed - whether you have viewed the latest version of the form.
  • Issue - forms with at least one open query, missing required data, or a pending form upgrade.
  • Edited - the date the form was last edited
  • Form review status:
    CRA - reviewed by Clinical Research Associate (CRA) or another role with review permission
    DM - reviewed by Data Manager (DM) or another role with review permission
    SDV - performed Source Data Verification (SDV)
  • Locked - whether the form is locked.

You can choose which columns you want to view by selecting the relevant checkbox in the Columns list.

In Batch view, you can:

  • Select all sites or an individual site to sign
  • Select all subjects, a group of subjects, or an individual subject
  • Expand a subject or a group of subjects to view all forms for the subject
  • Select all forms, an individual form, or a subset of the forms to sign

A filter icon is also available on the Signed, Edited, CRA, DM, SDV, and Locked columns, letting you filter the view by that column's value.

To batch sign forms:

1

Select the forms you want to sign as follows:

  • To sign all forms currently listed on the current page, select the checkbox in the header row of the table. To select every form that matches the filter across all pages, select Select all n forms on n subjects matching the criteria in the banner above the table.
  • To sign all forms for a subject, select the checkbox next to the subject.
  • To sign one form at a time, select the checkbox next to the form.
  • To sign specific events or forms for a subject, expand the subject and select the checkboxes for the events or forms you want to sign.

You can use the filters at the top of the page to narrow down the list before selecting forms to sign. For more information, see the Batch view on the Selection page.

Note! You cannot sign a form that is:

  • Locked for editing by another user
  • Has an open issue. Has an issue (missing required data, an open query, or a pending form upgrade)
  • Already signed
    If one specific subject's forms cannot be signed, signing continues for the remaining subjects/forms and the number of forms signed is shown on completion.
2

The number of forms and subjects currently selected is shown.

Select Sign:
3

The Review and confirm dialog opens, showing the total number of forms, subjects, and sites selected that can be signed and the review status (CRA, DM, SDV) of the selected forms.

Note!

  • If any of the selected forms have open issues, a message shows how many of the selected forms will not be signed for this reason.
  • If any of the selected forms are already signed, a message shows how many of the selected forms will not be signed again.
  • If you have not viewed all of the signable forms, a message is shown with the number of forms you have not viewed, and informs you that these forms will be signed and recorded in the audit trail.
  • If you select to sign all forms, the Select all n forms on n subjects matching the criteria dialog is shown to inform you that some forms are not shown in the view, and a checkbox to confirm that you understand that you are signing forms not shown in this view. You must select the checkbox before you can enter your password.
4

Enter your password in Confirm with password and select Submit.
The dialog shows how many forms, on how many subjects, were signed successfully.
During signing, the dialog shows the progress per subject, and when signing is complete, also lists the forms that could not be signed with the reason, for example, another user is editing the subject, or another user has signed or changed the form.

Note!

  • If you navigate away or close the browser before the batch sign is completed, forms not yet signed remain unsigned. You can choose to stop a batch sign before it is completed by selecting Cancel, and forms already signed at that point will remain signed.
  • Viedoc checks sign eligibility again at the time of signing, so the status shown in the batch view may already be out of date.
5

Select Close to return to the Batch view.

Note!

  • Viedoc signs each subject's forms independently, so if one subject's forms cannot be signed, signing continues for the remaining subjects. The confirmation message states how many forms were actually signed. You can select the same subjects again in a new batch, at a later time, to sign any forms that were left unsigned.
  • Batch signing is fully audit trailed and is distinct from single-form signing. Each form signed in a batch has an individual audit trail entry. The audit trail includes the confirmation summary shown before signing, and the acknowledgment of the Sign all warning, if shown.
  • Each form signed in a batch has its own signature (user, date and time) in the form history, the same as single-form signing. Viedoc also stores a record of the batch, with the summary shown before signing and the acknowledgment of the Sign all warning, if shown.
  • A batch must be completed within 30 minutes after you enter your password. Subjects that are not signed by then remain unsigned, and the result asks you to sign them again.

See also the video tutorial: Sign data.