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Edit placeholder

In eTMF, placeholders (also known as "planned documents") are folders or containers that store study documents and records planned to be collected during a clinical trial. With these documents and records, you can evaluate the clinical trial conduct, the integrity and quality of trial data, and compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements (ICH Guideline for GCP, E6, Section 8).

Some placeholders can only be used for file upload once, and others can be used multiple times.

For instance, the placeholder created for storing the monitoring visit confirmation letters from CTMS can be used multiple times to accept all the incoming files from CTMS. On the contrary, the placeholder created for the final version of a study protocol must be used only once for the file upload.

In eTMF, with the Edit option, you can configure how many times a placeholder can be used for file upload.

To edit the placeholder

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

  2. On the page that opens, in the left pane, select the Study List subtab.

  3. In the Study List table, select the needed study name.

    Selecting study
    Figure 1. Selecting study

  4. On the page that opens, select the Study Tracking pane option.

    Accessing study tracking page
    Figure 2. Accessing study tracking page

  5. On the Study Tracking page that opens, switch to the Placeholder tab.

    Accessing placeholders
    Figure 3. Accessing placeholders

  6. On the page that opens, depending on your needs, perform one of the following actions:

    1. To edit the placeholder usage configurations individually, next to the needed placeholder, from the Action(s) column, select Edit pencil_icon.png.

      Selecting to edit individual placeholder configurations
      Figure 4. Selecting to edit individual placeholder configurations

    2. To edit the placeholder usage configurations in batch, select the checkboxes next to the needed placeholders. From the workspace toolbar, select Edit pencil_icon.png.

      Selecting to edit placeholder configurations in batch
      Figure 5. Selecting to edit placeholder configurations in batch

  7. In the Edit dialog that appears, configure your placeholder usage as explained in the following table.

    Selecting to edit placeholder configurations in batch
    Figure 6. Selecting to edit placeholder configurations in batch

    Tip

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

    Element

    Details

    Times can be used

    Select one of the following options:

    • Fixed Value: to specify the exact number of times that the file can be uploaded to this placeholder.

    • No limitation: to permit the upload of the files to this placeholder without any restrictions.

      When the system initiates a new study, the Study Tracking placeholders can be autopopulated to eTMF with the No limitation value as the default. If needed, you can update this setting to the Fixed Value option.

    Specify the times it will be used*

    Enter the number of times that a file can be uploaded to this placeholder.

    This field is only available if Fixed Value is selected for the Times can be used field.

    SAVE

    Select save_button_white_red.png to apply the configuration.

    CANCEL

    Select cancel_button.png to discard the changes without saving.

Once saved, the usage configurations are applied to your placeholders.

In this section:

A person who is involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

A person who is the main line of communication between the sponsor and the investigator. The monitor provides assistance to investigators, ensuring that the trial is conducted and documented properly. In the clinical trial industry, often referred to as a clinical research monitor or clinical research associate (CRA).

An international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects.

ICH Guideline