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Import placeholders

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).

After introducing changes in bulk in the exported file with placeholder details, you can import these updates at once using the Import functionality, diminishing the manual effort in case of editing placeholders individually.

To import placeholders

  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. From the workspace toolbar of the contents panel that appears, select Import import_icon.png.

    Importing placeholders
    Figure 4. Importing placeholders

  7. Follow the prompts of your operating system to locate and select the needed spreadsheet.

    Locating XLSX file on your PC
    Figure 5. Locating XLSX file on your PC

    Tip

    If your file requires additional validation and fixes, you receive a similar prompt. Select OK, double-check the file, and reproduce steps 6-7.

    Prompting for additional required checks
    Figure 6. Prompting for additional required checks

Once selected, the placeholder usage configuration is imported into eTMF.

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