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View transferred documents list

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 responsible professionals per DIA RM.

The transferred document is a file that is originally uploaded in the temporary storage of Document Warehouse and later shifted to its desired location in Essential Documents. Once the desired location of the file is decided in the Essential Documents list, it can be uploaded from Document Warehouse. The files that are already uploaded to their designated location are removed from the warehouse storage. You can view the list of all these uploaded files in the Transferred Documents list. This assists you in keeping track of all files previously existing in the Document Warehouse storage, along with the details of their current location.

To view the transferred documents list

  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 Transferred Documents Transferred_Document_icon.png.

    Accessing transferred documents
    Figure 3. Accessing transferred documents

  5. In the Transferred Documents table that appears, view the details as explained in the following table.

    Viewing transferred documents list
    Figure 4. Viewing transferred documents list

    Element

    Details

    Document ID

    Represents the unique numerical identity of the file. This ID remains constant throughout the system.

    For instance, if a file is uploaded to Document Warehouse, and the ID assigned to it is 2345324. When the document is transferred to another location, its ID remains the same.

    Original File Name

    Represents the name assigned to the file when it was uploaded to Document Warehouse.

    File Level

    Represents whether the file is available at either of the following system levels:

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

    • Country: the transferred file is only available at the sites of the particular country.

    • Site: the transferred file is only available at a particular site.

    Country/Region Name

    Represents the name of the country to for which the file was provided. The country or region only appears if File Level is site or country.

    Site Code

    Represents the code of the site selected when uploading the file to Document Warehouse.

    File Type

    Represents the customly created category in eTMF of the file selected when uploading to Document Warehouse, for instance, if the file being uploaded contains original and initial content, then the file type is "Original Document".

    Author Name

    Represents the name of the user who uploaded the file initially to Document Warehouse.

    Author Account

    Represents the name login name of the user who uploaded the file initially to Document Warehouse.

    File Uploaded Time (UTC)

    Represents the date and time when the file was uploaded to Document Warehouse to a different location in Essential Documents.

    Transferred by

    Represents the name of the user who uploaded the file from Document Warehouse to a different location in Document Warehouse.

    Transferred Time

    Represents the time when the file was transferred from Document Warehouse to a different location in Essential Documents.

    Essential Document Path

    Represents the file directory where the file is currently available in the Essential Documents list.

You have viewed the list of all documents transferred from 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.