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Edit 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.

With time, the files stored in the Source Document module might require amendments, such as renaming or applying graphic changes to the documents.

For instance, the uploaded file contains sensitive information and you need to conceal it from other users accessing the storage to prevent a data breach. For this, use the Edit feature and blur specific parts of your PDF.

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 edit 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. Then select the directory containing the source document you want to edit.

  4. In the Source Document contents panel, next to the needed file, select Edit pencil_icon.png.

    Accessing editing option
    Figure 3. Accessing editing option

  5. On the Edit File page that opens, apply the needed changes as explained in the following table.

    Editing source document
    Figure 4. Editing source document

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    File Name*

    Enter the desired unique file name or edit the existing one to suit your needs.

    Previous Page

    Select back_arrow_icon.png to go to the previous page of the uploaded document.

    Next Page

    Select forward_arrow_icon.png to go to the next page of the uploaded document.

    Enlarge

    Select plus_circled_icon.png to scale up the file to see the smaller details of your document.

    Reduce

    Select minus_circled_icon.png to scale down the file.

    Reset

    Select restore_icon.png to discard any implemented changes and restore the file to its original state.

    Mosaic

    Select mosaic_tool_icon.png and then an area of the document to apply mosaic concealer and hide sensitive data elements.

    SAVE

    Select save_button_red.png to save the implemented changes.

    CANCEL

    Select cancel_button_white_blue.png discard any implemented changes and return to the source document list.

Upon saving, the changes are implemented. Now, when users preview the file in EDC or download it to their computer, they see the content as you amended it.

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.