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Delete 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 EDC, you can manually upload source document files under the Source Document module. If any document is uploaded by mistake or needs to be replaced, you can delete it from the system to keep the storage uncluttered.

Important

You cannot delete the file if:

  • The file status is Final—the review and approval procedure according to the associated workflow is complete.

  • The file status is Auditing as a result of workflow reset after being Final.

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 delete a 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. Then select the directory containing the source document you want to delete.

  4. In the Source Document contents panel, next to the needed file, select More more_actions_icon.png > Delete trash_can_icon.png.

    Deleting source document file
    Figure 3. Deleting source document file

  5. In the Reason dialog that appears, provide the details on why the document is being deleted, and select save_button_red.png.

    Confirming source document deletion
    Figure 4. Confirming source document deletion

Upon confirmation, the source document is deleted from EDC.

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.