Add a New Announcement

Users with appropriate permissions can create a message that appears in the Announcements area for all users with access to the page. On the User Home page, Business Administrators can create announcements; on a Study Home page, Business Administrators and Study Owners can create announcements.

1. Click the “+” next to Announcements. The Add an Announcement screen will display.
2. Enter the text of your Announcement in the box, up to 2000 characters.
3. Click Save. If you’ve created a study announcement, the Study Identifier will appear underneath the announcement text.

You can edit an announcement you’ve created. To access the Edit screen, select the announcement text and click the pencil icon.

To delete an announcement you’ve created, select the announcement text and click the trash can icon. On the Confirmation message, click OK. The announcement will no longer show to any user.

To dismiss an announcement so that it no longer appears in your announcements area, select the announcement text and click the x icon.

Add a New Note

Notes can be created by any user on the User Home page, a Study Home page, or within the metadata of a study item. Notes are displayed only to the user who created them and can be used to show reminders or other personal notations.

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 display on that Study’s Home page and on the User Home page. Notes created for a specific study item will be displayed in the Workspace Panel for that study item, on the related Study Home page, and on the User Home page.

Home Page Notes

To create a note on the User Home page or Study Home page:

1. Click the “+” next to My Notes. The Add a Note screen will be shown.
2. Enter the text of your note in the box, up to 2000 characters.
3. Click Save. If you’ve created a study note, the Study Identifier will appear underneath the note text.

To edit note text, select the text and click the pencil icon. Make the desired changes and click Save. To delete a note, select the text and click the trash can icon. On the Confirmation message, click OK.  Both actions will apply the change to all areas in which the note appears.

The Notes area on the User Home and Study Home pages provides an Actions menu from which you can do the following:

• Remove all notes
• Print notes

Document-Specific Notes

To add a document-specific note, open the Details view by clicking on the document name hyperlink within the study item list. In the Workspace Panel, expand the My Notes section and enter your note text. The text is automatically saved.Any notes entered will display on the Study Home page and User Home page with a link to the document.

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

If QC instructions for the document type are available, they will be displayed when you click expand Instructions in the Workspace panel.

If you have reviewed the content and metadata for the document and agree that it is accurate and complete, you may finalize the document by clicking the Finalize button in the Tasks tab.

1. Choose the Finalize button.

2. The Document will become Effective and the Task will be removed from your inbox

If you do not agree with any of the content and metadata for the document, you should not Finalize the document and should choose either Fail, Correct, Delegate, or Return.

Single Document Received and Study Item Exists

Use this method to create expected documents one at a time for Study Items that already exist:

1. Locate the study item
2. Choose create Expected Document (shown below)
3. Expected Document will be created and present in your Work Area
4. Navigate to your Work Area
5. Finish Indexing and generate transmittal

Single Document Expected and Study Item Exists

Use this method to create a single expected document if a matching Study Item already exists and you expect to receive and scan the document, but you don’t yet have the document:

1. Locate the study item
2. Choose Generate Transmittal
3. A Transmittal (cover sheet) will open for you to print
4. Expected Document will be created in your Work Area – no more action needed now
5. When the document is received, scan it in with the transmittal printed in step 3.

Create Multiple Expected Documents When Matching Study Items Exist

If study items already exist for multiple expected or received documents then:

1. Locate the study items and add to the Clipboard
2. From the Clipboard, choose Generate Expected Document.
3. Create Expected/Generate Transmittals dialog will display
   Note: Up to 50 Study Items can be processed at once.
   
4. From the “Create Expected / Generate Transmittals” screen, shown below,
   choose “I have received…” if you have the documents.
   choose “I plan to receive…” if you do not have the documents.

Expected and Received Documents Without Matching Study Items

If you have or expect documents, but matching Study Items do not exist, you will need to create Expected Documents and index to proposed Study Items.
To begin, use the Create Expected Docs button in Work Area List or Details view, shown below.

The “Create Expected Documents” screen, shown below, will allow you to create up to 100 Expected Documents at a time.
Be sure not to use this function when Study Items do not exist as considerably more indexing is needed.

Enter the number of documents you want to create and optionally, study, country, site
Click Add Documents.

Create Expected Documents in Bulk

1. You can mix and match studies, countries and sites
2. Each Expected Document is given a temporary name (“Expected Document – 1”) – change to a more meaningful value if desired
3. Click Create Documents when done
4. Expected Documents will be created in your Work Area, where you can complete desired indexing and generate Transmittals.