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Configure site, staff, and participating organization file storage location

In CTMS, you can configure the eTMF storage location of different files uploaded by the user for complementing the site, staff, and participating organizations details defined for the study.

To configure the site, staff, and participating organization file storage location

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page that opens, in the left pane, select Documentation Config.

    Accessing documentation configurations
    Figure 3. Accessing documentation configurations

  3. In the Site & Staff & Institution tab that opens by default, analyze the default eTMF locations set for the site, staff, and institutions. To modify the locations, update the fields as explained in the following table.

    Updating file storage location
    Figure 4. Updating file storage location

    Element

    Details

    Area: Site Personnel

    Specify the storage location of the files uploaded for the site personnel.

    Auto-store Trigger Condition

    Indicates the action that initiates file storage, for which you are defining the eTMF storage location. Currently, the only supported action is file upload.

    File Storage Root Path

    From the dropdown menu, select the file location where you want to store the uploaded file.

    Area: Site Documents

    Specify the storage location of the files uploaded for the site.

    Auto-store Trigger Condition

    Indicates the action that initiates file storage, for which you are defining the eTMF storage location. Currently, the only supported action is file upload.

    File Storage Root Path

    From the dropdown menu, select the file location where you want to store the uploaded file.

    Area: Staff

    Specify the storage location of the files uploaded for the study staff.

    Auto-store Trigger Condition

    Indicates the action that initiates file storage, for which you are defining the eTMF storage location. Currently, the only supported action is file upload.

    File Storage Root Path

    From the dropdown menu, select the file location where you want to store the uploaded file.

    Area: Participating Organization

    Specify the storage location of the files uploaded for the participating organization.

    Auto-store Trigger Condition

    Indicates the action that initiates file storage, for which you are defining the eTMF storage location. Currently, the only supported action is file upload.

    File Storage Root Path

    From the dropdown menu, select the file location where you want to store the uploaded file.

    SAVE

    Select save_button.png to save the configurations.

    Global Setting

    Select Global_setting_gray_gear_icon.png to open a dialog in which you can choose if you want to store the documents in the eTMF application's TMF module. Then select SAVE.

    Operation History

    Select history_icon.png to analyze the history of operations made with the documentation configurations.

Once saved, the configurations are defined.

In this section:

An electronic version of a trial master file (TMF) is a type of content management system for a clinical trial used to organize and store files required for compliance with government regulatory authorities like the FDA, EMA, or others.

Get to know all the possibilities of the app with the comprehensive eTMF User Guide.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

Group of individuals involved in making the study conduct possible. This includes various roles such as principal investigators, study coordinators, data managers, clinical research associates, and others who contribute to the planning, execution, and management of the study.

A data management, healthcare, software, or another organization that cooperates with the sponsor to provide data or services for a study.

See also: institution

A compilation of documents proving that the study is held following regulatory requirements. The TMF is a crucial part of ensuring the trial is successfully managed by all the involved parties.