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Edit file details in document warehouse

In eTMF, the Document Warehouse tab is mainly used for the temporary storage of some unorganized files so that, upon request, they can be organized by data managers (DM) and other accountable individuals per DIA RM and uploaded to the Essential Documents storage.

If needed, you can modify the details of the uploaded document, such as its name or level (site or country) to keep your information up-to-date in the document warehouse.

To edit the file details in the document warehouse

  1. In the eTMF application header, select the TMF tab.

  2. In the Study List that opens, from the table, select the name of the study for which you want to access the document warehouse.

    Selecting study
    Figure 1. Selecting study

  3. From the left pane, select the Document Warehouse subtab. If required, from the study selection field, you can change another study.

    Accessing document warehouse and study
    Figure 2. Accessing document warehouse and study

  4. From the explorer tree pane, select the directory containing the file you want to update.

  5. On the contents panel, locate the file and from the Actions column next to it, select Edit edit_pen_01.jpg.

    Selecting to edit file in document warehouse
    Figure 3. Selecting to edit file in document warehouse

  6. In the Edit dialog that opens, edit the attributes as explained in the following table.

    Editing file details
    Figure 4. Editing file details

    Elements

    Details

    File Name

    Represents the name of the file. Edit the file name by selecting the field.

    File level

    Represents the level of the file based on the selected directory. It is read-only.

    • Study Level: represents Study, if the selected directory is STUDY LEVEL.

    • Country Level: represents Country, if the selected directory is COUNTRY LEVEL. The level changes from site to country if a different country is selected in the country field.

    • Site Level: represents Site, if the selected directory is SITE LEVEL. The level changes from country to site if a different site is selected in the site code field.

    Country

    Select the country to which the file belongs.

    Site Code

    Select the site code to which the file belongs.

    OK

    Select ok_button.png to save your changes.

    CANCEL

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

Once saved, the file details are updated.

In this section:

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.