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Sign site/Remove signature

In EDC, when the data entry process for a site is completed, all the forms have passed the applicable review stages, and the site is soft-locked, the system requires the signature of designated personnel to validate the soft-lock operation.

In the STUDY INFO module, you can also configure the setting for PI signature so the designated personnel can still apply their signature without soft-locking the site. Before doing so, ensure that the site meets all the predefined conditions for the PI signature feature, such as required reviews and resolved queries.

Important

The signature functionality can be disabled for a site by managing the site-level settings.

Once the site is soft-locked and signed, no further data amendments are possible. However, there can be cases when some eligible changes must take place, and for such occasions, you can remove the signature from a site and then the unlock option becomes available. Once the signature is removed and the form is unlocked, you can perform your needed changes, and then soft-lock and sign your site again.

Important

When signing a site under the DATA ENTRY tab, and some forms of this site are missing signatures, the system asks you if you want to sign them altogether. If confirmed, upon signing a site you automatically sign all the pertinent forms. If declined, you cannot proceed with signing the site.

To sign a site or remove the signature

  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 title
    Figure 1. Selecting site title

  3. In the Subject List table that opens, select signn.png to sign the site or select Sign.png to remove the signature from the previously signed site.

    Selecting sign or unsign
    Figure 2. Selecting sign or unsign

    Important

    The Sign option is only available for sites in the Softlocked status.

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

    Entering user credentials
    Figure 3. Entering user 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 Subject List page.

    Important

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

Once the electronic signature is submitted, the subject is either signed or the signature is removed from it, depending upon the action performed.

In this section:

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

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.