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Study list

The Study List page displays a list of studies that are currently available to you in the eTMF system.

Important

The system automatically adds new studies to the Study List table after they are created in CTMS. You need to configure your study TMF base to complete the study initialization in the eTMF system.

The elements of Study List are explained in the following table.

Study list under TMF
Figure 1. Study list under TMF

Element

Details

Study Name

Represents the name of a study. Also, the name is an active link to the study details.

Select it to access the following pages:

Reference Model Type

Represents the reference model that has been used to create the study:

  • Custom: this value defines that the study has been created manually in the eTMF system using the TMF hierarchy template.

  • DIA: this value means that when creating a TMF base for this study, the user has selected the DIA as the reference model. If this option is selected, the system automatically initializes the built-in DIA RM structure.

Version

Represents the version number of the reference model.

Status

Represents whether the TMF base is locked or unlocked.

Total # Uploaded Files

Represents the number of master files that exist in the system.

# of My Files

Represents the number of master files that belong to you.

# of My Tasks

Represents the number of tasks you have in the scope of the current study, such as study query resolution.

# of Placeholders (Missing Files)

Represents the number of the placeholder documents for the study.

A placeholder is a document inserted in the place of the required study document that is unavailable, missing, or inapplicable. Placeholders are essential to maintain the structure and completeness of the TMF.

# of Expired Files

Represents the number of obsolete files in the study.

Select the linked number to be redirected to the Expired Files page, where you can analyze and manage the files.

Work Step Duration (days)

Represents the number of days required for completion of the study activity.

Automatically Parse File Properties

Defines whether the file properties must be populated in the system during file upload to eTMF with two values:

  • Yes: the file attributes are populated to eTMF automatically when uploading the files.

    If the file names and file type match, the system parses the file name and populates the corresponding default and customized attributes.

  • No: the file attributes are not populated during file upload.

From this page, you can perform the following actions:

In this section:

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

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

A non-profit association that enables knowledge exchange and collaboration for the companies involved in healthcare product development.

Learn more about DIA on its official website.

A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.