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Upload file to 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.

You can manually upload files from your computer to the document warehouse and assign them to either study, site, or country level. It is important to upload the file at the appropriate level, as it aids in successfully managing the files in the future and maintaining data integrity.

To upload a file to 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 workspace toolbar, select Upload File add_new_icon.png.

    Selecting option to upload file
    Figure 3. Selecting option to upload file

  5. In the Upload File panel that expands, select the upload area or drag the file you want to upload. Once the file is added, complete its attributes as explained in the following table.

    Uploading file to document warehouse
    Figure 4. Uploading file to document warehouse

    Tip

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

    Element

    Details

    Level*

    Select the level at which your file is going to be available:

    • Study Level: the file being uploaded is available at all the sites and countries of the selected study.

    • Site Level: the file being uploaded is only available for the selected site.

    • Country Level: the file being uploaded is only available at the sites of the selected country.

    Country/Region Name*

    Select the name of the country for which the file is to be available in the system.

    This field is only available if in the Level field, you have selected either the Country Level or Site Level value.

    Site Code*

    Select the code of the site for which the file is to be available in the system.

    This field is only available if in the Level field, you have selected the Site Level value.

    File Type

    Select the type of the file to distinguish the file purpose in the system.

    File types you see in the list are populated from File Type Setting.

    File Preview

    Select the eye icon eye_icon.png next to the file you are uploading to preview its content.

    SAVE

    Select save_button_red.png to implement the changes.

    CANCEL

    Select cancel_button.png to discard the changes without saving and close the file upload panel.

Once saved and the upload is successful, depending on the selected parameters—study, country, or site code—you can find your file in the corresponding directory of the explorer tree—STUDY, COUNTRY, or SITE.

Important

Once the access permission is provided by the ADMIN application, all the users can view all the files uploaded in Document Warehouse.

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.

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.