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Sign form/Remove signature

In the EDC application, from the DATA ENTRY tab, you can sign or remove the signature from the case report form (CRF) belonging to a certain subject and visit. Usually, the form signature is the responsibility of the principal investigator (PI) of the site, required to ensure that the entered data and changes made to the form are accurate. A form without a signature usually indicates that it is currently undergoing a development phase, and changes can still be made to it. Based on the study and site-level setting for the PI signature, the signed form can or cannot be amended, so there can be cases when the signature needs to be temporarily removed to introduce some eligible changes.

Important

A form can only be signed or the signature removed when it adheres to the conditions for the PI signature set at the study or at the site level in the STUDY INFO module.

To sign or remove a signature from a form

  1. In the EDC application header, select the DATA ENTRY tab.

  2. On the site list page that opens, select the tile representing the site with which you want to work.

    Selecting site tile
    Figure 1. Selecting site tile

  3. In the Subject List table that appears, select the ID of the subject to open their Visit Overview page.

    Selecting subject ID
    Figure 2. Selecting subject ID

  4. On the Visit Overview page that opens, on the left, a panel with all subject visits is displayed. Expand the needed visit to open the forms associated with that visit.

    Left panel. Visits and their forms
    Figure 3. Left panel. Visits and their forms

  5. Select the form that you want to sign or unsign.

  6. On the page that opens, from the workspace toolbar, select Sign sign_icon_white_red.png to provide your signature for the form that has no signature or select Unsign unsign.png to remove the signature from the previously signed form.

    Signing form
    Figure 4. Signing form

  7. In the Enter User Signing Password Information dialog appears, complete the fields as explained in the following table.

    Entering signature credentials
    Figure 5. Entering signature credentials

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Username or Email*

    Enter your username or email that you use to log in to the eClinical applications.

    Send Code

    Select send_code_button.png to send the temporary PIN code to your email for which the SSO method is configured.

    The button is only available if you use the authorization method via SSO.

    Code*

    Enter the temporary PIN code that you received via email.

    The field is only available if you use the authorization method via SSO.

    Password*

    Enter the password that you use to log in to the eClinical applications.

    The field is only available if you use the authorization method by providing your login and password.

    Submit Electronic Signature

    Select submit_electronic_signature_button.png to confirm your action with your signature and save the implemented changes.

    x_icon.png

    Select this icon to discard your action, close the dialog, and return to the Study Summary page.

    Important

    For security, the system logs you out after three failed attempts to confirm your identity with a password or code.

Once submitted, the form is signed or the signature is removed. For the signed form, a unique signature hashcode is generated and can be reviewed along with the signature information at any time.

See also

View form signature information

In the EDC application, some CRFs might require the signature of the liable personnel, such as PI, to verify their complaince. Each time the form is signed a unique hashcode is autogenerated. This hashcode is used to ensure the unique identification of the data and can be viewed along with the signature information. You can view the detailed signature information along with its unique hashcode at any time.

Important

You can view the form signature identification only.

To view the form signature information

  1. In the EDC application header, select the DATA ENTRY tab.

  2. On the site list page that opens, select the tile representing the site with which you want to work.

    Viewing site tile
    Figure 1. Viewing site tile

  3. In the Database ID column, select the ID of the subject to open their Visit Overview page and start working with visits and forms.

    Selecting Database ID
    Figure 2. Selecting Database ID

  4. On the Visit Overview page that opens, on the left, a panel with all subject visits is displayed. Expand the needed visit to open the forms associated with that visit.

    Left panel. Visits and their forms
    Figure 3. Left panel. Visits and their forms

  5. Select the form for which you want to view the hashcode signature.

  6. On the page that opens from the contents panel, select View Signature hashcode_button_.png.

    Selecting View Signature
    Figure 4. Selecting View Signature

  7. In the View Signature dialog, observe the signature information along with its unique hashcode.

    Viewing unique hashcode
    Figure 5. Viewing unique hashcode

You have viewed the signature information. Select ok_button_red_white.png to close the dialog.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.