Tag Archives: 2.4

Manage SiteZone Templates

The Manage SiteZone Templates screen allows you to choose which templates you would like to use in SiteZone for various Document Types.

Users in the MANAGE_SITEZONE_TEMPLATES security group can access the ‘Manage SiteZone Templates’ option from the More Actions menu in the Top Bar.

Templates created on the View eTMF Configurations screen will be available for use on the Manage SiteZone Templates screen if they apply to the document type that a template is being selected for.

The Reference Model ID for each Document Type is also displayed here.

What To Do If A Help Page Needs Updating

IQVIA Technologies is always looking to update, improve, and make the help pages as useful as possible.

If you find a help page that needs to be updated, improved, or just have a suggestion, please send your feedback to your business administrator and ask them to forward the information to the eTMF Help Desk.

Managing Other Users’ Inboxes

Business Administrators and Study Owners can view the Inboxes of other users in order to manage tasks. Business Administrators can manage all tasks, while Study Owners can manage tasks related to their studies.

Managing tasks may involve acquiring tasks, delegating tasks, or returning tasks from a user’s Inbox to the Group Inbox.  This may be necessary for users who are Out of Office or otherwise unable to tend to their Inbox.

The image below shows the Inbox as it appears to a Study Owner, who can use the values in the Narrow Choices panel to filter the Inbox by task owner, task type, etc.

Dump Object

The Dump Object option in Actions menus is a Business Administrator tool used for finding an item’s ID.

If you are having trouble with a specific item and plan to make a ticket to the eTMF Help Desk, it would be helpful to include the item’s ID from Dump Object so the Help Desk staff can better assess the issue.

Mark All Items as Unfulfilled

Mark All Items as Unfulfilled sets Marked As Fulfilled Study Items back to Unfulfilled, which re-enables them for  content uploaded.

Mark All Items as Unfulfilled Item from the Study Item List Action Menu. On the Mark All Items as Unfulfilled screen:

  1. Provide a Reason (required) and a comment (optional)
  2. Use the checkboxes on the left to select which Study Items to Mark as Unfulfilled.
  3. Click Mark Selected Unfulfilled

A green top-bar message, “Selected items have been marked unfulfilled.” will be displayed to inform you of the successful operation.

Additional Notes

The Study Item Clipboard can be helpful when gathering Study Item to Mark All Items as Unfulfilled.

Mark All Items as Unfulfilled can also be  from Favorites Items List, Recent Items List, or Study List.

There is a 50-item Study Item on each Mark All items As Unfulfilled operation. You will see a warning message if you attempt to Mark All Items as Unfulfilled with more than 50 Study Items.

Electronic Signature

When sending a document authored in the eTMF for approval, an eSignature approval workflow is available for selection. In this type of workflow, the approver must enter their eTMF login credentials as formal approval (i.e., the equivalent of a handwritten signature). Once the approval is issued and the document is finalized, a ‘Signature Page’ will be added to the document.

Note: Documents that require eApproval and not eSignature do not generate a Signature Page.

Signature Page

The Signature Page includes information such as the Document Name, Document Object ID, and a signature grid. The signature grid contains the names of users who signed the approval, the meaning of the signature for each user, the date/time of each signature, and a page number.

Modifying the Signature Page (Optional)

Business Administrators can modify the title, disclaimer, and logo present on the Signature Page.

  1. Click More in the application header and select “Administration.”
  2. On the eSignature tab, modify the title, disclaimer, and logo properties as needed.
  3. Click Actions and select “Save” from the menu.

Copy Document

What is Copy Document?

Copy Document is a quick way to make a duplicate of a Finalized or Obsolete document in your Work Area.

Who can use Copy Document?

Anyone with rights to Import Documents can use Copy Document.

When is Copy Document Useful?

If you have a copy of an Investigator CV already Finalized in one study and you need to add it to another study, you can use Copy Document to create a copy of the CV in your Work Area. Then, you can index the copy to the other study.

If you have a document that has been indexed incorrectly multiple times, especially one that has been through rework more than once, it can sometimes be helpful to get a fresh start by using Copy Document, then deleting the original document.

Documents that need to be used more than once within a single study should be multi-indexed instead of copied with Copy Document.

How to Copy Document

From the gear menu for a Finalized or Obsolete document on the study item list, select “Copy Document”
or
From the gear menu on the detail view of a Finalized or Obsolete document, select “Copy Document”

A green success banner will be displayed, letting you know that, “A copy of this document will be in your Work Area”

The status of the new document copy in your Work Area depends on whether it was originally uploaded or authored.  If the original document was uploaded, the document in your Work Area will have a status of ‘Uploaded’. If the original document was authored, the document in your Work Area will have a status of ‘Draft’.

Copy Document Notes and Additional Details

The copied document will have the same native file format as the original. If the native file format is configured to be renderable in your eTMF, a new PDF rendition will be created for the copied document.

Copy Document is not available on Program or Enterprise documents.

Copy Document operations are captured in the audit trail as “Document Copied” events.

Documents that need to be used more than once within a single study should be multi-indexed instead of copied with Copy Document.

If a document is Unblinded and you do not have rights to view Unblinded content, you will not be able to make a copy of the document.

Sites Grid

The Sites Grid allows you to easily navigate your recent and favorite Sites. It can be accessed by selecting the down arrow next to Study in the Study Grid and selecting Sites. To make the Sites Grid the default grid on the User Home Page, select the Make the Sites display my default star next to the Sites title.

The Sites Grid can be maximized by selecting the arrow in the top right corner of the grid. To return the grid to its original size, select the arrow again.

What Displays in the Sites Grid

Sites that you have recently viewed and sites that you have marked as Favorites are displayed in the Sites Grid. A site can be added to this area by selecting the More Sites button below the grid.

A Site in the Sites Grid can be Favorited or un-favorited by selecting the Flag this as a favorite star next to that site. When a site is favorited it will be blue and when it is unfavorited it will be white.

Using the Sites Grid to Navigate

In the Sites Grid, select the Site ID Hyperlink to view the Study Item List filtered down to the selected Country/Site. Select the Study hyperlink to view the Study Items List filtered to view all Countries/Sites within the selected Study.

Data regarding the Site’s Name, Sponsor, CTMS Status, Milestone, Metrics, Coming Due Study Items, and Past Due Study Items can be found to the right of a site in the Sites Grid.

Study Item vs. Document

In eTMF, Study Items work as placeholders for Documents that will be needed at a later point. An empty Study Item is one that has not had a Document Uploaded to it. Empty Study Items have the following icon:

Essentially, the Document is the content, whereas the Study Item is the placeholder and the description of what the Document is or will be. See Study Item Icons for more information about the different icons on list pages.

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