Skip to main content

View existing 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).

Placeholders are usually created based on the study milestones and essentially serve as containers for a missing study document or record planned to be received during a clinical study (such as consent forms, indemnity contracts, investigator's curricula vitae, and so on).

With eTMF, you can view the already created placeholders and use them to upload the needed study documents or records there.

To view existing 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. In the Placeholder table, view all the existing placeholders of your study and analyze their details as explained in the following table.

    Viewing existing study placeholders
    Figure 4. Viewing existing study placeholders

    Column

    Details

    Placeholder

    Represents the placeholder name that usually reflects the type of documents that you expect to be uploaded and stored in this placeholder once you collect them, for example, Core Document List, SOP Deviations, Committee Correspondence, and so on.

    Level

    Represents the level at which the documents are expected to be filed in this placeholder:

    • Study: the documents in this placeholder are filed at the clinical trial level (which means that the filed documents are relevant for all sites and countries within this study).

    • Country/Region: the documents in this placeholder are relevant for all study sites within a specific country.

    • Site: the documents in this placeholder are filed at the site level only.

    Country/Region Name

    If the placeholder level is set to Country/Region, the field displays the name of the country or region for which the documents in this placeholder are relevant to be filed. Otherwise, the field is empty.

    Site Code

    If the placeholder level is set to Site, the field displays the code of the site for which the documents in this placeholder are relevant to be filed. Otherwise, the field is empty.

    Zone

    Reflects the zone for your expected documents and records.

    For example, if your expected documents relate to the general design or management and oversight of the trial, the Trial Management zone is displayed; if your expected documents relate to regulatory submissions and approvals (to/from health authorities), the Regulatory zone is displayed, and much more.

    Section

    Represents the name of the section into which the previously selected zone was divided.

    Artifact

    Represents the name of the artifact you are planning to upload into your placeholder.

    Time(s) Can Be Used

    Represents the number of times that files can be uploaded to this placeholder. You can set or change this number by editing the placeholder usage configurations.

    # of Uploaded Files

    Represents the number of files uploaded for this placeholder.

    Status

    Represents the current status of the placeholder, such as Empty, Incompletely Filled, or Completely Filled.

You have viewed the list of all existing 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

In eTMF, a highest level directory within the file storage organized according to the Drug Information Association Reference Model (DIA RM). Zones are typically used to categorize documents by their role or type within the clinical trial. The zone helps with the general document grouping that may later be subdivided into specific sections and artifacts.

Zones can represent large groups of documents such as regulatory documents, study documentation, clinical trial agreements, and so on.

In eTMF, the lowest level of the file directory predefined by the Drug Information Association Reference Model (DIA RM). Artifact-level folders exist within a section and store individual documents—the actual files related to the clinical trial that are stored in the eTMF system.

Artifacts could include files of regulatory submissions, consent forms, clinical trial protocols, or monitoring visit reports.