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Download exported source document archive from history

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, you can manually upload and store the source document files under the Source Document module. If required, you can also export all the available documents of a certain site and have them downloaded to your computer as a ZIP archive. All such exported archives are tracked by the system and can be downloaded at any time from Export History.

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 download the exported source document archive from the history

  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. From the workspace toolbar of the Source Document contents panel, select Export History history_icon.png.

    Accessing source document export history
    Figure 3. Accessing source document export history

  4. In the Export History dialog that opens, next to the file you want to download, select download_icon.png.

    Downloading exported source document archive from history
    Figure 4. Downloading exported source document archive from history

Once downloaded, the source document archive becomes available on your computer. Select ok_button_red_white.png to close the dialog.

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.

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.

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.