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Browse available source documents

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 the uploaded source files are stored under the Source Document module in the hierarchical structure that aids you in browsing for files that belong to certain sites, subjects, visits, or even particular CRFs.

By browsing the existing directories and available files, you can check if all the required source documents are collected or if there is a need to collect some missing ones.

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 browse the available source documents

  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. On the page that opens, optionally set up the filters to assist you in locating the needed documents as explained in the following table.

    Setting source document filters
    Figure 3. Setting source document filters

    Element

    Details

    Site Code

    Select the unique identifier of the site to display the source document directories that belong to it.

    Subject ID

    Select the unique identifier of the subject to display the source document directories that belong to them.

    Visit Name

    Select the name of the visit to display the source document directories that belong to it.

    Form Name

    Select the name of the CRF to display the source document directories that belong to it.

    SDV/SDR

    Select one of the following:

    • SDV Required: to browse the directories whose files are intended for source data verification (SDV).

    • SDR Required: to browse the directories whose files are intended for source data review (SDR).

    Empty Folder Only

    Select Yes or No to show only the empty directories. Leave the selection cleared if you want to see both empty directories and the ones with files.

    Indicating empty folders might be helpful, for instance, if you want to check what source files are missing and should be uploaded for a certain site or subject.

  4. In the Hierarchy tree, expand the directories to locate the needed files as follows:

    • site_icon.png: the site-level directory 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 and you can see the files within only if the Show Child File(s) toggle is turned on.

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

    • visit_directory_icon.png: the visit-level directory 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_directory_icon.png: the form-level directory 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.

    Accessing source document directory
    Figure 4. Accessing source document directory

    Tip

    Here are some useful tips to navigate the source document storage:

    • The number next to each directory shows how many files are uploaded there.

    • Turn on the Show Child File(s) toggle to display the files belonging to the currently selected directory and the files of all its child-level folders.

      Showing child-level files
      Figure 5. Showing child-level files

      For instance, when selecting a visit-level directory in the hierarchy tree, you can see the source documents that belong to that visit and all the CRFs within.

    • Select Refresh refresh_icon.png to clear all the selections and collapse the expanded directories.

  5. In the Source Documents contents panel, find all the files pertinent to the selected directory or—if the Show Child File(s) toggle is turned on—its child-level files as well.

    Reviewing source document files in directory
    Figure 6. Reviewing source document files in directory

You have browsed the available source documents of your study in EDC.

Tip

To get more insights on the available source documents of your study, you can access the comprehensive source document tracker report by selecting Go to Chart chart_icon.png on the workspace toolbar.

Accessing source document tracker report
Figure 7. Accessing source document tracker report

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.

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.