Placeholder settings

Placeholder settings are configurations and parameters that govern how placeholders are managed within eTMF. This may include rules for when placeholders should be created, assigned, or removed, as well as workflows associated with the placeholders.

These configurations help standardize the management of placeholders, ensuring consistency across the trial. They enable organizations to define which documents require placeholders and the criteria for managing those markers effectively.

Figure 1. Placeholder settings

In this section, you can learn how to:

Create placeholder setting

Placeholder settings 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 Curricula Vitae, and so on).

In eTMF, you can create placeholder settings in two ways, as explained in the following sections.

Add placeholder settings individually

In the eTMF system, you can create the placeholder settings in batch by downloading the predefined placeholder template, filling it in with the necessary data, and then importing the completed file back into the eTMF system. This can be handy when you need to create many placeholder settings at once, and configuring them individually is too time-consuming.

To create placeholder settings individually

In the eTMF application header, select the TMF tab.
On the page that opens, in the left pane, select the Study List subtab.
In the Study List table, select the needed study name.

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Study Tracking page that opens, switch to the Placeholder tab.

Figure 3. Accessing placeholders
From the workspace toolbar, select Setting .

Figure 4. Accessing placeholder settings
On the Placeholder Setting page that opens, from the workspace toolbar, select New .

Figure 5. Accessing option to create placeholder setting

In the New dialog that opens, provide the details for your placeholder, as explained in the following table.

Figure 6. Adding new artifact

Element	Details
Placeholder	Enter the placeholder name. The name must reflect the type of the expected documents that will later be stored in this placeholder once you collect and upload them. For example, Core Document List, SOP Deviations, Committee Correspondence, and so on.
Zone	Select the placeholder subfolder that reflects the zone for your expected documents. The following zones are available for selection: Zone #1. Trial Management Select it if your expected documents relate to the general design, management, and oversight of the trial; include information about the trial team, project management and tracking, committees and charters, and training. Zone #1. Trial Management select it if your expected documents relate to the general design, management, and oversight of the trial; include information about the trial team, project management and tracking, committees and charters, and training. Zone #3. Regulatory Select it if your expected documents relate to regulatory submissions and approvals (to or from health authorities), regulatory filing and registration information, and regulatory notifications specific to the clinical trial. Zone #4. IRB or IEC and other Approvals Select it if your expected documents relate to official communications and exchanges with IRB’s/IECs and other equivalent committees, including central, national, regional, and local. It may include records related to IRB/IEC submissions, approvals, acknowledgments, as well as oversight information about the IRB/IEC. Zone #5. Site Management Select it if your expected documents relate to the selection, setup, and management of investigational sites. It may include central site training and central monitor training. Zone #6. IP and Trial Supplies Select it if your expected documents relate to the investigational products (IP), including instructions for shipping, storage, handling, returns and destruction, regulatory requirements, certificates, treatment allocation and decoding, and inventory information. Zone #7. Safety Reporting Select it if your expected documents relate to trial-specific safety and pharmacovigilance management. This includes the safety management plan, safety database line listings, safety reports, and non-submission communications and documentation. Note that safety notifications to IEC/IRBs must be placed in zone 4 and safety notifications to regulatory authorities must be placed in zone 3. Zone #8. Centralized and Local Testing Select it if your expected documents relate to the central and local laboratory's SOPs, certification (and expiration dates), procedure manuals, current normal value ranges, and the Laboratory Director's curriculum vitae (CV). Zone #9. Third Parties Select it if your expected documents relate to the establishment and maintenance of a relationship between sponsors and the vendors/3rd-parties serving sponsors by contract on the trial. Zone #10. Data Management Select it if your expected documents relate to data management activity on the trial. It may include subject data (completed CRFs or Final EDC Data) and the design and establishment of databases. Zone #11. Statistics Select it if your expected documents relate to biostatistics and statistical programming activity on the trial.
Section	Select one of the sections into which the previously selected zone is divided. The values you see in this dropdown menu depend on the selected zone.
Artifact	Select the artifact you are going to upload to your placeholder.

Once Zone, Section, and Artifact are configured, in the same dialog, continue selecting the level at which each artifact must be typically filed based on its content, as explained in the following table.

For example, if an artifact has been customized for an individual site, the Site Level checkbox must be selected.

Element	Details
Study Level	Select the checkbox if an artifact is to be filed at the clinical trial level (if it is relevant to all sites or countries within a trial).
Country/Region Level	Select the checkbox if an artifact is to be filed at the country level (if it is relevant to all sites within a certain country).
Site Level	Select the checkbox if an artifact is to be filed at the site level only.
SAVE	Select to implement the changes.
CANCEL	Select to discard the changes without saving.

Upon saving, the new placeholder setting is created and displayed in the Placeholder Setting table. You can now proceed to upload your expected documents and records to the newly created placeholder setting.

Add placeholder setting in batch

In the eTMF system, you can create the placeholder settings in batch by downloading the predefined placeholder setting template, filling it in with the necessary data, and then importing the completed file back into the eTMF system. This can be handy when you need to create many placeholder settings at once, and configuring them individually is too time-consuming.

To create placeholder setting in batch

In the eTMF application header, select the TMF tab.
On the page that opens, in the left pane, select the Study List subtab.
In the Study List table, select the needed study name.

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Study Tracking page that opens, switch to the Placeholder tab.

Figure 3. Accessing placeholders
From the workspace toolbar, select Setting .

Figure 4. Accessing placeholder settings
Download the predefined placeholder setting template from the eTMF system:
1. On the Placeholder Setting page that opens, on the workspace toolbar, select Download Template .
  
  Figure 5. Downloading placeholder list template
2. Follow the prompts of your computer to save the file.
3. On your computer, open the downloaded file and fill it out with the needed information.
  
  Figure 6. Downloaded template filled out
  
  Tip
  
  To understand what each column in a template means so you can fill it out properly, see the table of the Add placeholder settings individually section.
Import the file back to the eTMF system to generate the list of placeholder settings:
1. On the Placeholder Setting page, from the workspace toolbar, select Import .
  
  Figure 7. Importing placeholder list
2. Follow the prompts on your computer to locate and upload (import) the filled-out file in the eTMF application.

The placeholder settings from the file appear in the Placeholder Setting table. Now, you can proceed to upload your expected documents and records to the newly created placeholders.

Edit placeholder setting

Initially, placeholder settings (folders and containers) are created in the eTMF system based on the study type, phase, vendors, protocol type, and so on. However, sometimes, you may need to edit the existing placeholder settings. For example, if you need to change the placeholder setting name or change its grouping level.

To update the details of a placeholder setting

In the eTMF application header, select the TMF tab.
On the page that opens, in the left pane, select the Study List subtab.
In the Study List table, select the needed study name.

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Study Tracking page that opens, switch to the Placeholder tab.

Figure 3. Accessing placeholders
On the Placeholder page, from the workspace toolbar, select Setting .

Figure 4. Accessing placeholder settings
On the Placeholder Setting page that opens, in the table, next to a placeholder you need to edit, select Edit .

Figure 5. Selecting to edit placeholder details
In the Edit dialog that appears, update the placeholder setting details—such as its name, zone, section, or artifact. The fields here are identical to the ones explained in the table of the Add placeholder settings individually section.

Figure 6. Editing placeholder

Upon saving, the placeholder setting is updated. You can now proceed to upload your study documents and records to the placeholder according to the updated settings.

View placeholder setting audit trail

Placeholder settings are usually created according to the study plan and protocol based on the study milestones and essentially serve as containers for a missing study document or record planned to be received during a clinical trial (such as consent forms, indemnity contracts, investigator Curricula Vitae, and so on).

In eTMF, you can view the audit trail of existing placeholder settings; that is, you can track when and how the placeholder setting was created or modified.

To view the placeholder setting audit trail

In the eTMF application header, select the TMF tab.
On the page that opens, in the left pane, select the Study List subtab.
In the Study List table, select the needed study name.

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Study Tracking page that opens, switch to the Placeholder tab.

Figure 3. Accessing placeholders
On the Placeholder page, from the workspace toolbar, select Setting .

Figure 4. Accessing placeholder settings
On the Placeholder Setting page that opens, in the table, go to the needed placeholder setting. Then in the Actions column next to it, select Audit Trail .

Figure 5. Accessing audit trail of placeholder setting
In the Audit Trail dialog that appears, view the audit trail of the placeholder setting (that is, check what was the placeholder setting name when it was first created, to which study it belongs, what zone, section, and artifact it has, and when (if ever) it was changed and how).

Figure 6. Viewing placeholder audit trail
Select to close the dialog.

Once done, you are redirected to the Placeholder Setting page where you can continue working with your placeholders.

Export placeholder setting

In the eTMF application, you can export placeholder settings for a particular study to work with them offline and import them back into eTMF. With this functionality, you can update the existing placeholder settings in bulk instead of editing them one by one.

To export the placeholder setting

In the eTMF application header, select the TMF tab.
On the page that opens, in the left pane, select the Study List subtab.
In the Study List table, select the needed study name.

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Study Tracking page that opens, switch to the Placeholder tab.

Figure 3. Accessing placeholders
On the Placeholder page, from the workspace toolbar, select Setting .

Figure 4. Accessing placeholder settings
In the Placeholder Settings page that opens, from the workspace toolbar, select Export .

Figure 5. Exporting placeholder settings

Once exported, the file is saved on your system in the XLSX format. You can now work with it offline.

Delete placeholder setting

To keep the list of placeholder settings up-to-date, you may need to remove the ones that are no longer needed. However, you cannot delete placeholders that already have stored study documents.

To delete a placeholder setting

In the eTMF application header, select the TMF tab.
On the page that opens, in the left pane, select the Study List subtab.
In the Study List table, select the needed study name.

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Study Tracking page that opens, switch to the Placeholder tab.

Figure 3. Accessing placeholders
On the Placeholder page, from the workspace toolbar, select Setting .

Figure 4. Accessing placeholder settings
On the Placeholder Setting page that opens, select checkboxes next to the placeholder settings you want to delete, and from the workspace toolbar, select Delete .

Figure 5. Deleting placeholder setting
In the Delete confirmation dialog that opens, select to delete the selected placeholder settings.

Figure 6. Confirming placeholder deletion

Important

If the placeholder setting already stores some study documents, the system displays an error message informing you that the placeholder setting cannot be deleted.

Upon confirmation, the placeholder settings are deleted.

In this section: