Skip to main content

Upload source document

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 the EDC application, you can manually upload source document files under the Source Document module in the hierarchical structure as follows:

  • Site-level directory site_icon.png: comprises source documents that belong to subjects—and their visits and forms—registered at a certain site. This directory is not intended for file upload by default and this cannot be changed.

  • Subject-level directory subject_icon.png: intended for the source documents that belong to a certain patient. For instance, it can be the informed consent form original copy.

  • Visit-level directory visit_directory_icon.png: intended for the source documents that belong to a certain visit. For instance, it can be the approved work instruction or standard operation procedure document.

  • Form-level directory form_directory_icon.png: intended for the source documents that belong to a certain CRF. For instance, it can be the original copy of the CRF completed by the doctor conducting a visit for a subject.

Important

The directory level to which you can upload files depends on the source document upload configuration of your study.

The procedure of file upload depends on the workflow associated with the intended site-level directory. If the workflow requires user verification upon file submission, then the system requests for electronic signature along with uploading the file.

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 upload the source document

  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 to which you want to upload the source document—subject-, visit-, or form-level.

  4. Then from the workspace toolbar of the Source Document panel, select Upload upload_icon.png.

    Selecting to upload file
    Figure 3. Selecting to upload file

  5. On the Upload File(s) page that opens, select or drag the file to the designated area for the upload. You can upload multiple files at once.

    Uploading source document files
    Figure 4. Uploading source document files

    Tip

    Use the file editing tools to redact your source document upon upload. For instance, use Mosaic mosaic_tool_icon.png to conceal sensitive data and then select OK red_check_icon.png to save the changes.

    Redacting source document
    Figure 5. Redacting source document

  6. Select save_button_red.png to start the upload and save the file(s) in the selected directory.

  7. If the associated workflow requires file submission confirmation, in the Signature dialog that appears, provide your credentials as explained in the following table.

    Confirming file upload (submission)
    Figure 6. Confirming file upload (submission)

    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.

    I am the author of this document(s)

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

    SAVE

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

    CANCEL

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

Upon saving, the uploaded document appears in the selected directory.

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.

A document that provides essential information about a clinical trial to potential participants to ensure their complete understanding of the research nature, the risks and potential benefits involved, and their rights as participants.

Before enrolling in a clinical trial, participants must read and understand the information in the ICF, and signing the ICF indicates their willingness to participate, understanding that they have been fully informed about the study.

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.