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Reset source document workflow

Source documents are original records or certified copies of records that provide evidence of the existence, activities, and results of a clinical trial or study. Some of the source documents that can be related to data verification and documentation review are case report forms (CRFs), medical records, informed consent forms, pharmacy records, adverse event reports, regulatory documents, and so on.

In EDC, the procedure of the source document handling is controlled by workflows, introducing an additional tier of scrutiny and the approval/rejection mechanism to reduce the risk of unintended impact on sensitive resources and important information.

At any time of source document maintenance in the system, you might be required to reset its workflow and reinitiate the review and approval procedure from the start.

This might become helpful, for instance, if the document is edited and requires a follow-up review of all the users in charge.

Important

The ability to view and manage the Source Document page depends on the permission granted to your user role in ADMIN.

Reviewing permissions for source document handling
Figure 1. Reviewing permissions for source document handling

To reset the source document workflow

  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane of the page that opens, select Subject > Source Document.

    Accessing source documents
    Figure 2. Accessing source documents

  3. In the Hierarchy tree that appears, expand the site of your interest and select the directory where resides the source document for which you need to restart the workflow.

  4. In the Source Document contents panel, next to the needed document, select More more_actions_icon.png > Reset Workflow reset_workflow_icon.png.

    Resetting source document workflow
    Figure 3. Resetting source document workflow

  5. In the Reset Workflow dialog that appears, confirm your action with credentials as explained in the following table.

    Confirming source document workflow reset
    Figure 4. Confirming source document workflow reset

    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 system.

    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.

    Title

    Represents the title of the user assigned to them via the ADMIN application. The field is autopopulated by the system and cannot be entered manually.

    Comment*

    Select this checkbox to confirm that you are the author of the documents being uploaded.

    CONFIRM

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

    CANCEL

    Select cancel_button_white_black.png to discard the changes, close the dialog, and return to the Upload File(s) page.

Upon confirmation, the workflow of the document is reset and returns to its initial point. The document status becomes Auditing.

In this section:

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

See also eCRF.

An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.