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Placeholders process tracking

Placeholders represent expected documents for the study even before these documents are prepared. Placeholders serve as digital reminders for the organization, ensuring that all necessary documents will be added throughout the study development lifecycle.

A study can have several placeholders, and each placeholder can contain one or more files related to the study. When a file is uploaded for an artifact from the Essential Documents page, you can select which placeholder the file will be placed in. The uploaded file is associated with an artifact at the study, country, or site level defined at the time of creation.

The Placeholders tab of the Process Tracking dashboard helps eTMF users to track and manage placeholder progress within a specific study.

The statistics in the form of color-coded bars and pie charts give you a visually appealing representation of the complex study data.

Viewing placeholders data
Figure 1. Viewing placeholders data

Tip

You can sort out the Placeholders statistics by file levels: Study, Country, or Site. At the top of the page, you can find dropdown menus to select the study and the file level and display the dashboard data according to your preferences.

Selecting file level to display statistics
Figure 2. Selecting file level to display statistics

The Placeholders dashboard consists of multiple blocks as explained in the following table.

Block

Details

Placeholders Count

(chart)

Displays the percentage of the placeholders' completion for the current month in the form of a color-coded speedometer pie chart:

  • green_color_code.png: green for completed placeholders that have all the expected documents uploaded to them.

  • gray_green_color_code.png: gray and green for outstanding placeholders that are empty or incompletely filled.

  • gray_red_color_code.png: gray and red for past-due outstanding placeholders that are empty or incompletely filled and their expected completion date has passed.

The percentage of the current month's placeholders' completion is counted according to the formula below:

Current month's placeholders' completion = Current month's completed placeholders / Current month's total placeholders.

Placeholders Completed

Displays the number of completed placeholders for the current month and statistical comparison to the same value on a monthly (MoM) and yearly (YOY) basis.

Placeholders Completion

Displays the placeholders' completion percentage for the current month in the form of a progress bar. The percentage of the current month's placeholders' completion is counted according to the formula above.

Placeholders Past Due

Displays the count of overdue placeholders for the current month and statistical comparison to the same value on a monthly (MoM) and yearly (YOY) basis.

Placeholders Count

(numbers)

Displays the percentage and count of placeholders by three categories (completed, uncompleted, and past due). Here, the system only counts placeholders for the associated milestones that have arrived. The arrived milestone means its planned start day has come or passed. To view details of the count select the count which redirects to the Placeholder List (Completed) page.

Viewing details of Placeholder List (Completed)
Figure 3. Viewing details of Placeholder List (Completed)

Placeholders Progress

Displays the correlation of empty and filled placeholders in the form of a bar chart. Select any bar to view the detailed count of the total, filled, and empty placeholders.

Viewing details of placeholder progress
Figure 4. Viewing details of placeholder progress

If you are viewing the statistics for the study, the chart is displayed by file levels (study, country, and site). If you select the statistics for specific file levels, the data will be organized by different parameters (for instance, by approval status, country, site, or else).

Placeholders Compliance

Displays the placeholder compliance rate to the milestone that has arrived but is not yet completed.

Select the placeholder number in each category to expand the Placeholder List panel. In the table that appears, you can select the placeholder name link to navigate to the Essential Documents page and perform needed actions with that placeholder. For instance, upload the file for an empty placeholder.

Expanding placeholder list
Figure 5. Expanding placeholder list

Outstanding Placeholders

Displays the count of empty and incompletely filled placeholders in different folder types according to DIA RM: In Core Folders, In Recommended Folders, or Others.

Core or Recommended is an artifact-level folder attribute predefined by the DIA RM to specify whether the artifacts in this folder are mandatory (core) or optional (recommended) for collection. The custom-created folders within the DIA RM-structured file explorer are categorized as Other.

Select the placeholder number in each folder to expand the Placeholder List panel. In the table that appears, you can select the placeholder name link to navigate to the Essential Documents page and upload the file for this placeholder or perform other actions.
See also
In this section:

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.