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Configure source document upload setting

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, all source files are uploaded stored 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: comprises 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: comprises 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: comprises 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.

However, to better suit your business needs, you can customize the levels intended for file upload in your study. This helps you maintain organized storage and avoid file misplacement between different levels of directories, such as uploading CRF-related files to a visit folder.

For instance, if you only intend to store the original copies of subject CRFs in your EDC system, then you can configure file upload functionality to be available only for the form-level directories.

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 configure the source document upload setting

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

  2. On the page that opens, from the workspace toolbar of the Hierarchy block, select Source Document Setting source_document_setting_icon.png.

    Accessing source document upload setting
    Figure 2. Accessing source document upload setting

  3. In the Source Document Setting dialog that appears, configure the file upload setting as explained in the following table.

    Configuring source document upload setting
    Figure 3. Configuring source document upload setting

    Element

    Details

    Subject Level

    Select this option if you want to allow for the source document file upload to be available in directories pertaining to a certain subject.

    Subject & Visit Levels

    Select this option if you want to allow for the source document file upload to be available in directories pertaining to a certain subject and visit.

    Subject & Visit & Form Levels

    Select this option if you want to allow for the source document file upload to be available in directories pertaining to a certain subject, visit, and form.

    SAVE

    Select save_button_white_red.png to save the configuration.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes without saving and close the dialog.

Once saved, the established file upload configuration is applied. The user can now upload source documents only to the set directories.

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.