To View the Version History for any Document Templates, Workflow Definitions, or Workflow Task Definitions, access the Actions menu associated with the object and select “View Versions.”

The View Versions window will display the previous versions of the configuration and their metadata. Each version has its own Actions menu that allows you to:

• View Native Content (if not PDF)
• View PDF in Acrobat
• View PDF in Browser
• View metadata

If the Configuration has multiple pages of Versions, the pages of Versions can be changed by selecting the arrows at the bottom of the View Versions window.

You can author a document within eTMF. When documents are authored in eTMF, the user has the ability to check out the content while in Draft status, make changes, and upload the changes to the system. The user also has the ability to share authoring responsibilities with another user.

To finalize an authored document, it must be sent through an approval workflow (which may or may not be an eSignature workflow).

To author a document, navigate to your Work Area and click the Author Document button (the rightmost button). Or, from the Actions menu of an unfulfilled Study Item, select “Author New Content.”

Differences in the Two Ways to Author a New Document

Author Document Button (Work Area)

• Used if study item does not already existing on the study item list
• Must select the study to which the content belongs and, if you need to propose a new study item, select a document type from the master list
• Able to create content for enterprise or program level documents
• Able to select from list of applicable templates or import content

Author New Content (Unfulfilled Study Item)

• Used if study Item already exists on the Study Items List
• Allows for minimal Indexing
• Not available for Enterprise or Program level documents
• Able to select from list of applicable templates or import content

Authoring a New Document From a Template or by Importing Content

Using either of the methods above, you must choose the base content file. This file can be chosen from a list of existing document templates in the system or by importing an existing file.

Use a Document Template

A document template is typically used when the content does not yet exist. The template serves as the starting point to create the content of the document.

Note: Document templates are configured by Business Administrators and can be of any eTMF acceptable file type.

When you choose to author content, the list of document templates you can select from is limited to those applicable for the document type of the study item. You can limit the list by a specific language using the Template Language drop-down. If limiting by language, you can also select the adjacent check box to include English language templates in addition to those for the selected language.

Once a template has been selected, click Create. This will add the document to your Work Area where you can continue authoring it by checking it out to your local machine.

Import a File

To import a document that has been partially authored outside the eTMF, click Import Document. This will display the Upload to Study Item screen. Click Select File, navigate to and double-click on the file you want to upload, and click Upload. The will add the document to your Work Area where you can continue authoring it by checking it out to your local machine.

The eTMF allows a Study Owner to make study items that were activated with incorrect metadata/content or that are no longer needed obsolete. Study items can be made obsolete individually or in bulk.

To make all items in a list obsolete and retire them, access the list view’s Actions menu and select “Make Obsolete and Retire All Items. ” If your list contains more than 50 items, a message is displayed, stating that the action will be performed on the first 50 items. You will need to repeat the action on additional items. Click OK to continue.

The Make Obsolete and Retire All Items screen lists all items within your list that the system is able to obsolete. If any items from the list cannot be obsoleted (e.g., items in the list are not final or you do not have permission to obsolete them), a message is displayed along the top of the screen.

On the Make Obsolete and Retire All Items screen, select a Reason and enter any Comments you might have. Deselect the check box for any study items you do not want to make obsolete. Click Obsolete and Retire Selected. The document status will be updated to Obsolete.

Users in the Distribute Documents group can Distribute Program Level Documents (such as safety reports) to sites for document types that are marked as Distributable in the eTMF. The document must be Final before it can be distributed. You can choose specific sites to which the document should be distributed.

Distributing a document results in two actions:

• Linking of the document into each study for which a site was chosen (unless it has already been linked into that study). After linking, the Program level document will appear in the Study Item list for the study.
• Creating a record in the Audit Trail of when the document was distributed to the site

How to Distribute a Document

To distribute a document, select the “Distribute Document” option on the document’s Actions menu. On the Distribute Document screen, select which sites the document will be distributed to.

• The document can be distributed to any or all sites for studies associated with its Program that are not locked or archived
• The grid will not display sites to which the document has already been distributed
• Use the filters on the left hand side of the dialog to select sites for only specific studies or countries, or to eliminate sites based on their status or most recent milestone
• To select all displayed sites, select the box above the grid

When the appropriate sites have been selected, click Distribute. You can distribute the document multiple times based on different conditions. Close the dialog when done.

You can generate a distribution report to view distribution information in an Excel file that can be downloaded from the Downloads page.  If the document has been acknowledged by the site, the name of the person who acknowledged the document will display in the report, as well as the date of acknowledgement.

Note that all sites will display in the report, but only the sites selected to receive the document will show a distribution date.

Notes can be added for a particular study on the Study Home page. Once added on the Study Home Page, they will display on the My Notes section of the User Home page.

Study Notes are personal to the user and can only be viewed by the user who created them.

Create a Note

To create a note, navigate to the My Study Notes portion of the Study Home page and select the Add Study Note option (“+” icon).

The Add a Note dialog will display, and you will be prompted to enter the desired Study Note text. When all desired text has been entered, click Save.

The study note will then display in the My Study Notes section of the Study Home. It will include the associated study (and hyperlink to the study),the note text and time posted.

Edit a Note

To edit a previously created note, navigate to the My Study Notes tile, select the note and click the Edit Note icon (pencil icon).

This will open the Edit a Note window where you can enter any desired changes. When you click Save, the window will close, and the edited note will appear in the My Notes section of the Study Home page.

Delete a Note

To delete a note from the Study Home page, navigate to the My Study Notes component, select the note, and select the Delete Note icon (garbage can icon).

The note will no longer appear in the My Notes section of the Study Home Page.

You can also perform these steps from the User Home page.

Use the Forgot Password link on the login page when :

• You are signing in to the eTMF for the first time, have the URL for the environment, and have not been sent a link to set your password
• You are unable to remember your password

1. On the Login screen, click Forgot Password.
2. Enter your email address and click Send. If the email address is valid, you will receive an email message with the subject “eTMF Forgot Password.”
3. Open the email and click on the link within the body of the email.
4. Enter your new password.
5. Enter the password a second time to confirm.
6. Click Submit.

You can now login with your new password.