The Mark Item Fulfilled function allows a Study Owner to record that a Study Item will not be fulfilled by a document in the eTMF. Marking a study item as fulfilled will allow the item to be tracked in the metrics as a fulfilled study item as opposed to having the item show as missing.

How to Mark all Items as Fulfilled

To mark all Study Items as Fulfilled, select the Actions Menu above the items list and select “Mark All As Fulfilled.” If there are more than 50 items in the study you will be alerted that you can only Fulfill a maximum of 50 tasks at a time. Clicking Ok on the alert will allow you to proceed with the first 50 items selected.

The Mark All Items as Fulfilled screen will display. If there are items in the study that could not be marked as fulfilled, the screen will display an alert saying that the Study Items that could be marked as fulfilled are shown below.

Choose a reason from the Reason drop-down and enter additional Comments if necessary.

Review the list of Study Items and deselect any that you do not wish to mark as fulfilled. Once the list has been reviewed, click Mark Selected Fulfilled.

The selected Study Items will now appear as Fulfilled without Content (icon), and the change to the Study Items will be recorded in the Audit Trail.

The Create Expected/Generate Transmittals screen is used to create expected documents and generate transmittals for items in bulk. Use when the Items List is filtered down to results that the user has the documents for or expects to receive documents for.

To reach the Create Expected/Generate Transmittals screen, select Create Expected/Generate Transmittals from the Actions Menu on the Study Items List page, Favorite Study Items page, or Study Items Clipboard. If there are more than 50 items listed on the page you will receive a warning that the operation can only be performed on a maximum of 50 items at a time. Selecting Ok will allow you to proceed with the first 50 items selected.

Reasons for an Alert

You may receive an alert that some of the selected study items could not have an Expected Document created for them. Potential reasons for why study items could not have an expected document created for them include that the study is locked or archived, the study item is Ad-hoc or proposed, or the study item is at the enterprise or program level.

How to use the Create Expected/Generate Transmittals Screen

From the Create Expected/Generate Transmittals screen, choose one of the two options based on the documents that you have selected.

Option 1: “I have received these documents.” Use this option when you have received the selected documents already and want to create Expected Documents in your Work Area for them.

Option 2: “I plan to receive these documents.” Use this option when you have not yet received the selected documents but wish to generate Transmittal for them now so they can be Indexed once they are scanned.

By default all documents in the list will be selected. Any documents which you do not wish to Create Expected Documents for can be deselected by clicking the green box next to that option.

When only the appropriate documents are selected, click Create Expected Documents to finalize the operation.

What Do Saved Filters Do?

Saved filters store combinations of filter values so that you can rapidly apply them in the future without having to manually re-select the values from the Narrow Choices panel.

Saved filters do not include the Study, Country and Site context applied with the breadcrumb trail. As a result, you can create a saved filter in one Study-Country-Site context, then apply it in another context.

When Do Saved Filters Help?

Saved filters can save you time if there are complex sets of filter criteria you need to apply repeatedly.

For example, if you need to monitor incoming Investigator CV documents from three specific investigators, you could apply a Document Type filter for “Investigator CV” documents, a Site Personnel Name filter for the three investigators by name and a Document Status filter of “InQC”, then save your filter combination so that you can automatically apply the filter combination again with a single click.

Who Can Save Filters?

Any eTMF user can make filters and save them for their own use.

Users who are members of the “TMF Share Saved Filter” group are able to share their saved filters with others.

Working with Saved Filters

All of the controls for working with Saved Filters begin with the Filter Actions menu icon in the Filters panel, shown with the Filters Options list below.

Save a New Filter

1. Set the filter criteria you want to save.
2. Click the Actions menu icon at the top of the Narrow Choices panel and select “Save As” from the menu.
3. Provide a name for the saved filter.
4. (Optional) If you have permissions needed to share saved filters, enter the name of one or more users with whom you want to share the filter in the User(s) field.
5. (Optional) In the Groups field, enter the group(s) to share the filter with.  
6. Click Save.

Apply an Existing Saved Filter

Apply a saved filter from the Actions menu in the Narrow Choices panel. Filters that you have created yourself will be shown under the Saved Filters heading.

The Saved Filters that are available to you are only those that apply to the type of list you are accessing. For example, filters saved on the study item list are available on the study item list,  study item clipboard, recents, or favorites views. Filters saved in the Inbox are available only in the Inbox and on the task clipboard.

Save Changes to an Existing Saved Filter

When a saved filter is applied to a list, you can make changes to the filter and save it by selecting “Save” from the Actions menu in the Narrow Choices panel and clicking Save on the Save Filters dialog. Saving will overwrite the existing filter definition with the currently applied filter set.

Share an Existing Filter with a New User or Group

If you have the appropriate permissions, you can share a new filter you are saving with another user. You can also share a filter you’ve previously saved with other users by following the steps below.

1. Click the filters action menu icon in the Narrow Choices panel, and click Save As.
2. Enter the name of a user you want to share the filter with in the Users field. Repeat to add additional users.
3. In the Groups field, enter the groups to share the filter with.  
4. Click Save.

Any active user can be the recipient of a shared filter, although some users may not be able to use some shared filters.

For example, a Work Area filter can be shared with a user in a TMF Reader Role who does not have a Work Area. However, the TMF Reader will not see a Work Area filter shared with them because they do not have access to the Work Area.

Apply a Shared Filter

Apply a shared filter from the Actions menu in the Narrow Choices panel.  Filters that others have created and shared with you will be shown under the Shared Filters heading.

Revoke User Access to a Shared Filter

To stop sharing a saved filter with another user:

1. Apply the filter to be shared.
2. Click the Filters actions menu icon and select “Save.”
3. On the Save Filter dialog, click the “x” button at the right edge of the row for the user to be removed.
4. Click Save.
5. Confirm when prompted to overwrite the existing saved filter.

Remove a Shared Filter from Your List of Shared Filters

If you no longer want to use a filter that has been shared with you, click on the Actions menu icon in the Narrow Choices panel, hover over the Shared Filter name in the menu, and click the “x” on the row for that filter. This removes the filter from your list of Shared Filters but does not delete the filter from the system (only the user who created the filter can delete it).

Delete a Saved Filter

To remove a filter from your Saved Filters, click on the Actions menu icon in the Narrow Choices panel, hover over the Saved Filter name in the menu, and click the “x” on the row for that filter. The saved filter will be removed from the system and will also become unavailable to anyone you had shared it with.

Note: Users who have access to a shared filter through their membership in a group will not have the ability to remove the shared filter from their Shared Filters list. The filter will only be removed from a user’s list of Shared Filters if:  

• The filter owner deletes the filter  
• The filter owner modifies the filter to remove groups of which the user is a member  
• The user is removed from a group with whom the filter was shared 

Users with appropriate permissions can access the Document Template List by selecting the More Actions menu in the Top Bar and selecting View eTMF Configurations.

The Document Templates List is where the templates used to author documents in the eTMF can be managed. From the Document Template List you can change content, metadata, or create new templates.

The list of templates can be filtered using the Facets to the left of the Template List.

To create a new template, select the Actions menu next to the Items Found count and select Create New Template. This will display the Create Document Template Window.

Actions can be performed on individual Templates by selecting the actions menu next to that Template.

You can set your out-of-office status in eTMF to automatically delegate your tasks to another user. With the appropriate permissions (i.e, Manage Users feature permissions), you can also set out-of-office status for another user.

To set an office status, navigate to the right side of any page in the eTMF and select your user name to display an associated drop-down menu. From the menu, select “Set Out of Office.”

The Set Out-of-Office dialog will display.

Set Out-of-Office Status

To set a user to have the status of ‘out-of-office’, select the “Yes” option for the Is Out-of-Office Enabled toggle in the Set Out-Of-Office window.

To set an out-of-office status for an indefinite period of time, select the “No” option for the Is Using Out Of Office Range toggle. To set a timeframe for the out-of-office status, select “Yes” for the Is Using Out Of Office Range toggle. Then, select a desired start date/time and end date/time using the associated fields.

Indicate whether or not you want to delegate tasks that are already in your inbox by selecting either “Yes” or “No” in the toggle associated to the Delegate Current Tasks if Out of Office Enabled option.

Then, select a user to delegate all current (if applicable) and future tasks to while out of office by using the Workflow Delegate drop-down. All tasks sent to you while you are out of office will then be sent to the user you selected. Available users are those with the same role(s) as the out-of-office user. If the out-of-office user has study-specific access, the available users are also limited to those with access to the same studies.

Click Save. The window will close. If you have set yourself as out-of-office, an Out-of-Office icon will be displayed next to your username in the top right corner of the page. If you have set another user as out-of-office, the icon will be displayed in the same location for that user when they log into the system.

Manually End Out-of-Office Status

To manually end your out-of-office status (e.g. if you selected No in the Is Using Out Of Office Range toggle when initiating the Out-of-Office status), navigate to the right side of any page in the eTMF and select your user name to display an associated drop-down menu. From the menu, select “Set Out of Office.”

The Set Out-of-Office window will show that the user is currently Out-of-Office.

Select “No” for the Is Out of Office Enabled toggle and click Save.

The Set Out-of-Office window will close, tasks will no longer be delegated to the designated Out-of-Office recipient, and the Out-of-Office icon will no longer display next to the user’s username in the top right corner of the eTMF.

Empty Study Items that are unnecessary may be deleted by users with appropriate permissions. Study Items should only be deleted if they were created in error or are no longer relevant to the specific study. Study Items that are fulfilled (either with or without content, and even if not activated) cannot be deleted.

Tip: For study items that do not need to be present in the TMF that either need a permanent record or cannot be deleted, use the Mark as Fulfilled option. To remove a study item that has been fulfilled or finalized, use the “Virtual Delete” functionality.

Items that can be deleted: 

• Documents marked as Core in the master list but not added to your study by a study, country, or site wizard.  
• Documents that do not have the Is Core setting.  

 Items that cannot be deleted:  

• Documents marked as Core in the master list and added to your study using the study, country, or site wizard.  Note: These study items have an Is Core setting. 

To delete a single study item:

1. Go to the study item, click the Actions Menu icon, then select Delete Study Item. 

2. In the Delete Study Item component window, select a Reason, enter additional Comments if necessary, and click Delete. 

The study item will no longer appear in the TMF, and the action will be recorded in the audit trail.

Note: If you believe that a Study Item that should have a ‘Delete’ option does not have that option on its Actions menu, it could be because the Item had a Final document fulfilling it at one time.

To delete all study items:

1. In the Study Items List page, select the actions menu and select Delete All. Note: If there are more than 50 items on the Study Items List page you will be alerted that you can only delete a maximum of 50 items at a time.
2. In the Delete All Items window, select a Reason.
3. Enter a Comment.
4. (Optional) Deselect any items you do not wish to be deleted.
5. Click Delete Selected.

Add a note to display a personal reminder in the Notes area on your User Home page or a Study Home page. Add an announcement to display a message that appears in the Announcements area of the User Home page or a Study Home page for all users.

Neither system-wide nor study-specific announcements are treated as “TMF content”, so they are not included in exports or treated as official files.

Add a New Announcement

Users with appropriate permissions can create a message that appears in the Announcements area for all users.

1. Click the “+” next to Announcements.
2. The Edit Announcement screen will display.
3. Enter the text of your Announcement in the box.
4. Click Save.

Note: Announcements are limited to 2000 characters. The counter in the bottom right corner of the Add an Announcement window shows how many characters you have entered in the box so far.

Add a New Note

Notes can be created on the User Home Page or a Study Home Page. To create a Note that will appear in the My Notes area only for the logged in user:

1. Click the “+” next to My Notes
2. The Add a Note screen will be shown.
3. Enter the text of your Note in the box
4. Click Save

Notes created on the User Home Page will only be displayed on the User Home Page. Notes created on a Study’s Home Page will only display on that Study’s Home Page.

Notes are limited to 2000 characters. The counter on the bottom right corner of the Add a Note window shows how many characters you have entered.

If you are using Google Chrome or another compatible browser and need to upload a document to a study item, you can drag a file from your file explorer and drop it directly onto the Study Item as shown below.

The document will go to the user’s Work Area for Indexing.  You can drag and drop as many files as you like before indexing.

If a study item already has finalized content, the dropped file will become a new version once finalized.

Note: Drag and Drop capabilities will be disabled for program level study items, enterprise level study items, ad hoc study items, proposed study items, and study items requiring mediation (i.e., study items missing required field values as a result of an Update Placeholders operation).