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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 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 Curricula Vitae, and so on).

Each placeholder has a strict organizational structure. This means that it has a specific structure of subfolders, Placeholder > Zones > Sections > Artifacts, so that you can easily upload the needed study documents and records to the right folder.

Placeholder organization structure
Figure 1. Placeholder organization structure

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The purpose of each folder and subfolder is explained in detail later in the Add placeholder settings individually section.

In this section, you can learn how to:

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.

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