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Clarivate Regulatory Intelligence Tracker App

(ClaRITA)
USER GUIDE
Clarivate Regulatory Intelligence Tracker App – User Guide

Contents
Introduction & aim ..................................................................................................................... 4

Minimum requirements.............................................................................................................. 4

Authentication and account registration ................................................................................. 5

User roles and permissions ...................................................................................................... 6

Navigation Menu ........................................................................................................................ 8

Document metrics dashboard ................................................................................................ 10

Document time stamp ............................................................................................................................................ 11

Document charts ..................................................................................................................................................... 11

Daily updates............................................................................................................................ 13

List of regulatory updates ....................................................................................................................................... 14

Search and filtering ................................................................................................................................................. 14

My saved filters ....................................................................................................................................................... 15

Quick search buttons .............................................................................................................................................. 15

Download data ........................................................................................................................................................ 16

Regulatory update card........................................................................................................................................... 16

Detailed view .......................................................................................................................................................... 17

Individual view ........................................................................................................................................................ 21

My tasks .................................................................................................................................... 22

To do ....................................................................................................................................................................... 22

My mentions ........................................................................................................................................................... 24

Closed tasks............................................................................................................................................................. 25

My Function(s) ........................................................................................................................................................ 27

Review reminder email ........................................................................................................................................... 29

Administration .......................................................................................................................... 30

Pre-publication triage ............................................................................................................................................. 30

New document........................................................................................................................................................ 32

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Detailed view and management ............................................................................................................................. 34

Status .................................................................................................................................................................... 34

Priority ................................................................................................................................................................... 35

Review date ........................................................................................................................................................... 35

Adding review cycle and assigning Group/Function and Reviewer ............................................................................ 35

Impact assessment ................................................................................................................................................. 37

Open items .............................................................................................................................................................. 39

Closed items ............................................................................................................................................................ 42

Performance ........................................................................................................................................................... 43

User Management .................................................................................................................................................. 48

Groups and Functions assignment ........................................................................................................................... 51

Group management ................................................................................................................................................ 52

Group filters toggle ................................................................................................................................................. 54

Notifications ............................................................................................................................................................ 56

Support ..................................................................................................................................... 59

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Clarivate Regulatory Intelligence Tracker App – User Guide

Introduction & aim


Clarivate Regulatory Intelligence Tracker App (ClaRITA) web application enables Regulatory Intelligence
experts and other users to access, share and track the Clarivate Regulatory Intelligence across the globe.
The system allows users to discover the latest or most relevant regulatory updates according to a number
of criteria as well as discuss and record what actions need or have been taken as a response to a regulatory
change.

Minimum requirements
The application is accessible as a web page, using following browser:

Google Chrome

Microsoft Edge

Mozilla Firefox

Other browsers and older versions may work correctly but are not officially supported.

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Authentication and account registration


By default, the access to the application is controlled by the use of a username (email address) and
password (see Figure 1).

When a new account is created, details are sent automatically to the user’s email address. You will need
to follow the link in the email within 24 hours in order to set your password and activate your account.
The link expires after 24 hours and the account will need to be recreated by the administrator.

Passwords can be reset following the “Forgot password?” link on the login page. A link to reset the
password will be sent to the user’s email address, provided that an account for this email address exists
in the system.

Figure 1. ClaRITA Login page

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User roles and permissions


There are three user roles in the system:

Administrator: user with this user role has the full access to the system and all functionalities.
Administrator has permission to perform following activities:

 Pre-publication triage
 New document creation
 Regulatory update Status assignment
 Regulatory update Priority assignment
 Regulatory update Review date assignment
 Regulatory update new Review cycle assignment
 Group and Individual Task assignment
 Impact assessment
 Regulatory update search and filter, review
 Regulatory update sharing
 Commenting
 Statistics monitoring
 Performance reports
 Notification setting
 User management
 Group management
Supervisor: user with this user role has limited access to the system and functionalities as
compared to Administrator. Supervisor has permission to perform following activities:

 Regulatory update search and filter, review


 Regulatory update sharing
 Commenting
 Impact assessment
 Regulatory update Status editing (only the updates with review assigned to Supervisor or
to the Group/Function that Supervisor belongs)

 Regulatory update Priority editing (only the updates with review assigned to Supervisor or
to the Group/Function that Supervisor belongs)

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 Regulatory update Review date editing (only the updates with review assigned to
Supervisor or to the Group/Function that Supervisor belongs)

 Task self-assignment (only for the updates with review assigned to the Group/Function
that Supervisor belongs)
User: user with this user role has the most limited access to the system and functionalities as
compared to Administrator and Supervisor. User has permission to perform following activities:

 Regulatory update search and filter, review


 Regulatory update sharing
 Commenting

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Navigation Menu
The navigation menu at the top of every page contains links to the main sections of the system. Access to
sections is controlled through role permissions described in the previous section.

A user with “Administrator” role that has the full permissions will see links to (see Figure 2):
Dashboard: linking to the main Document metrics dashboard page.

Daily updates: linking to the page that lists and allows searching and browsing of all regulatory
updates available on the system.

My tasks: linking to a user area that contains the user’s:

 “To do” page


 “My mentions” page
 “Closed tasks” page
 “My Function(s)” page
 Review reminder email
Administration: contains tools that enable Administrators to:

 Triage new regulatory updates


 Monitor and manage Open and Closed items
 Run performance reports
 Manage users
 Manage groups
 Manage notifications
User profile: this icon contains a link to the user’s profile from which basic profile details can be
edited. It also contains the log out button.

User documentation: this is a link to the current User guideline document.

Figure 2. ClaRITA Administrator Navigation menu

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A user with “Supervisor” and “User” roles will see links to (see Figure 3):
Dashboard: linking to the main Document metrics dashboard page.

Daily updates: linking to the page that lists and allows searching and browsing of all regulatory
updates available on the system.

My tasks: linking to a user area that contains the user’s:

 “To do” page (not available to the role “User”)


 “My mentions” page
 “Closed tasks” page (not available to the role “User”)
 “My Function(s)” page (not available to the role “User”)

Figure 3. ClaRITA Navigation menu

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Document metrics dashboard


This is the landing page for all users after successful authentication. This page contains predefined
snapshots of recently added or updated regulatory documents into the application (see Figure 4).

Figure 4. ClaRITA Document metrics Dashboard page

The page contains:

Pre-set time period selector (Figure 4- ): a drop-down option to select from a list of predefined
time periods. Time periods and the total number of the periods in the list are configurable*.

Topic tabs (Figure 4- ): a set of tabs showing the number of publications, for the selected period,
grouped by topic.

The total number of items listed as “All news” is lower than the sum of items listed under
individual topics, because each item can belong to multiple topics.

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New documents charts (Figure 4- ): this section contains a breakdown of all items, by country,
published in the application in the selected time period, and for the selected topic. Items are
visualized as a tree map or a choropleth.

*ask your Clarivate ClaRITA administrator for configuration options.

Document time stamp


ClaRITA document time stamp (Figure 4- ) is configurable*. Published documents can be distributed in
the time boxes by either

 Date added to CRI


or

 Date added to ClaRITA


*ask your Clarivate ClaRITA administrator for configuration options.

Document charts
The tree map (see Figure 4- ) and choropleth (see Figure 5) show the number of publications by country,
for the selected time period. Each topic is shown as a separate tab, so moving between tabs updates the
chart for the corresponding topic.

Users can switch between the tree map and choropleth from the toggle button on the top right of the
charts section.

All areas on the charts, i.e. either boxes on the tree map or countries and regions on the choropleth are
clickable. Clicking on one of them, will load the “Daily updates” page with applied filters:

 Country/Region (area that was clicked)

 Selected time period (from the selected time box)


 Topic (based on the selected horizontal tab above the chart)

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Figure 5. ClaRITA Choropleth

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Daily updates
All users can navigate to the Daily Updates page (Figure 6) by either:

 Clicking on the “Daily updates” menu item on the navigation bar. This opens up the page
with no filters applied.

 Clicking on any area on the tree map or choropleth of the Dashboard main page. This opens
up the page with the relevant time period, topic and country/region filters applied.

Figure 6. ClaRITA Daily updates page

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List of regulatory updates


Regulatory updates that match the selected filters, if any, are shown on the main part of the page as
separate cards (Figure 6- ). By default, cards are sorted according to the date added to ClaRITA or date
added to CRI (depending on the document time stamp configuration described above) with the newest
items at the top. The sorting order can be changed to show the most recently updated items at the top,
even if they are historic regulatory updates that happened to have been updated recently.

The total number of updates on the page is displayed on the top of the list (Figure 6- )

Search and filtering


Regulatory updates can be searched and filtered using the tools on the right part of the page.

The free-text search (Figure 6- ) allows searching for any terms contained in the Title, Abstract or
Comments section of the regulatory update, or by update IDRAC number.

The search by user (Figure 6- ) allows searching for any regulatory updates that have reviews assigned
to the certain user. Search can be performed by one user name at a time.

“Filter by date” layout, when unfold, displays the list of dates that can be used as filters (Figure 6- ),
allowing, for example, the discovery of regulatory updates that were published between specific dates or
that have been marked with a specific Review By date.

Additional filters (Figure 6- ) can also be applied, on:

Priority

Topic

Country/Region

Document type

Status

Regulatory versions

Product Categories

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Search and filtering are combined to allow the discovery of content that matches multiple
criteria, such as, for example, a combination of free-text search, dates and metadata tags.

My saved filters
On the top of the filter list (Figure 6- ) there is a "My saved filters" field available to all users. It allows
to create and save personal set of filters on the Daily Updates page, by using the filters provided by the
application: Priority, Topic, Country/Region, Document type, Status, Regulatory versions, Product
Categories.

To create a filter in “My saved filters”, user should select any combination of filters from the list above
and press the "Save filter" button in “My saved filters” field that becomes active only when at least one
filter from provided ones is selected. This will open the dialog box allowing to name and save the filter.
Each new personal filter must be set with unique set of provided filters and must be given a unique name.

After the user creates new personal filter, it appears in the list of "My saved filters" and gets selected
automatically.

Only one personal filter at a time can be selected by the user.

Once the personal filter is selected, user always sees it as "active" in "My saved filters" list, and on
the Daily Updates page user always sees the batch of documents relevant to this selected personal filter,
namely:

 after page reload,


 after user leaves the page and returns to it in some time (but staying logged in the system),
 after re-logging in the system.

To switch off personal filter user must manually unselect it in the "My saved filters" list.

To delete the personal filter, user should press the "recycle bin" button next to the filter's name.

Quick search buttons


Button “Recently updated” (Figure 6- ) allows the user to filter the documents that were updated in
last 24 hours.

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Button “Show my tasks” (Figure 6- ) allows the user to filter the documents that have reviews assigned
to him.

Download data
“Download updates as Excel” button (Figure 6- ) allows the user to download all the documents with
metadata present on the Daily updates page as an Excel file.

Regulatory update card


Each regulatory update card (Figure 7) contains:

A colored bar on the left side of the card (red, orange, yellow, green, grey, etc.), indicating the
priority assigned to the alert (Figure 7- ). Priority can be assigned by users with certain
permissions on the Pre-publication triage page and/or on the Daily updates page.

The names, colors and number of priorities are configurable*

A set of dates, if available, at the top (Figure 7- ):

 Added to ClaRITA: the date the record was promoted to ClaRITA Daily updates from
Administration Pre-publication triage,

 Added to CRI: the date the record was added to Cortellis Regulatory Intelligence,
 Last updated in CRI: the date the record was updated in Cortellis Regulatory Intelligence,
 Posted by authority: the date the publication was originally posted by the relevant authority,

 Coming into force: the date the legislation or regulation is expected to come into force. This
date only applies to a subset of regulatory updates,

 Review by date: this is an internal deadline, set by Administrators of the application.


Country or Region that the regulation applies to (Figure 7- )

Topics that the regulatory update is tagged with by CRI editors (Figure 7- )

Title (Figure 7- )

Abstract: a summary created by CRI editors (Figure 7- )

Comments: created by CRI editors (Figure 7- )

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A status tag in the left bottom corner of the card (e.g. New, In Progress, Closed): statuses are
changed by users with permissions to change them and indicate the current status of review, if
applicable (Figure 7- ).

The names, colors and number of statuses are configurable*

Regulatory version (None, Draft, Final, Amendment, Revision, Withdrawn, Implementation)


(Figure 7- ).

A set of counters displaying the number of comments, views and shares (Figure 7- ).

*ask your Clarivate ClaRITA administrator for configuration options.

Figure 7. ClaRITA Regulatory update card

Detailed view
Clicking on a regulatory card, brings up a detailed view of the regulatory update as a pop-up (Figure 8).
The detailed view displays all the regulatory update content, but without truncation as well as additional
information that has been manually edited by ClaRITA users with appropriate permissions.

Users with permissions to edit information can make changes to the fields in the blue-shaded section of
the page “Review and Impact Assessment”.

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Figure 8. ClaRITA, Detailed Regulatory update card view

Additional information, not shown in the card list view, but available in the update detailed view includes:

Link to the full document in Cortellis: “Arrow” button in the top left corner of the detailed view
pop-up next to the IDRAC number will take user to the relevant regulatory update page in Cortellis.

Link to the update Individual view: “Paper” button in the top right corner of the detailed view
regulatory card, next to the “Share” and “Close” buttons brings up an Individual view of the
regulatory update on a separate page.

Review and Impact Assessment: white foldable Review cycle box in the blue-shaded area of the
update detailed view, with review cycle(s) that contains the names of the Group and Function, and
the Reviewer that the regulatory update is assigned to for action, if applicable.

Users with permissions (Supervisors or Administrators) can change the assignment from this view
or assign the update to themselves using “Assign to me” button or assign the update for group
review using “Assign for group review” button.

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When unfolded, Review cycle box contains Impact assessment questions that indicate the possible
impact of the regulatory update to the company. Questions can be answered with a “Yes/No” flag,
as well as additional comments can be added to each question by clicking “Edit” button. The “Edit”
button appears when a “Yes/No” answer is selected from the drop-down field that allows users to
leave specific comments.

Links to other documents (Figure 9): the field that can be used to add links to either the documents
within ClaRITA or any external document. All users can add links in this section. To add the link
user should press "Link the document" button that will open dialog box to add the link URL
address, name the link and save it. Both the links and link names created within one document
must be unique. For linking of internal ClaRITA documents the user must use the URL address of
the document Individual view. Users can delete the existing links by pressing the "recycle bin"
button next to the link.

Comments (Figure 9): all users can add their comments in this section. All users can see comments
previously submitted by other users. It is also possible to “tag” a user, by typing “@” and their
name. Tagging a user sends a notification to them that they have been mentioned and adds the
mention to the users’ “My mentions” list in My tasks.

Events Timeline (Figure 9): this is a graphical representation of important dates and events in the
lifecycle of the regulatory update:

 Posted by authority,
 Added to CRI,
 Status changes: only the new status is shown,
 Priority changes: only the new priority is shown,
 Assignments to Group/Function and user for action, shown as “{User} assigned to {User}”,
 Review status change: only the new status is shown,
 Changes to impact assessment, shown as “{User} edited impact assessment for review cycle
{Group/Function}”,

 Review by date: this is shown as a milestone (diamond shaped) and is marked in red if the
current date is after the review by date and the status is not “Closed” or “No action
required”.

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Timeline bar can be zoomed in by selecting the area of the bar with the left button of the mouse,
zoom out is done by double-click of the left button of the mouse.

Figure 9. ClaRITA, Regulatory update card timeline

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Individual view
The Individual view (Figure 10) displays all the regulatory update content available on the detailed view
pop-up, as well as additional options to download the regulatory update using relevant buttons in a form
of:

 Word document,
 PDF document.

Figure 10. ClaRITA, Individual Regulatory update card view

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My tasks
All users have access to “My tasks” section. In this section users with roles “Administrator” and
“Supervisor” can both manage tasks that have been assigned to them and the tasks closed by them, and
review updates where they have been mentioned in comments. Users with role “User” only can review
updates where they have been mentioned in comments.

To do
This page is available only to the users with roles “Administrator” and “Supervisor”.

Regulatory updates that have reviews assigned to a specific Reviewer for action are organized in the user’s
“To do” list (Figure 11). This page contains only items that are in an “open” status (New, In Progress, etc),
i.e. not marked with status “Closed” or “No action required”.

The page contains a Summary section, showing the total number of open items assigned to the user, as
well as a break-down by Group/Function, Topic, Priority and Review by date period relative to now.

Metrics on the Summary dashboard can also be used as filters, by clicking on them to select them.
Selecting a metric, filters the list for the relevant attribute.

Regulatory Updates that match the selected criteria, if any, are shown in the table below the Summary
dashboard. Users can click on any of the rows of the table and bring up the detailed view of the Regulatory
Update, from which they can add comments or make changes depending on their permissions level.

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Figure 11. ClaRITA My tasks, To do list

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My mentions
This page is available to all the users, and this is the only page of My tasks section available to the role
“User”.

When a user is tagged (mentioned) in one of the comments, the comment is added to the list on this page
in the “Comment” column, together with the corresponding regulatory update that comment belongs to
(see Figure 12). Users can browse this list to quickly see where, by whom and why they have been
mentioned and provide their feedback if required.

Figure 12. ClaRITA My Tasks, My mentions page

Mentioning a user in a comment does not create any responsibility for any action or follow-up, it is mainly
used for information sharing. Users who have been tagged may choose not to respond at all or they can
add their own comments if they wish to do so.

Also, when a user with permission for document review and impact assessment is tagged (mentioned) in
one of the note fields of the Impact assessment questions, the comment is added to the list on this page
in the separate column “Impact Assessment”, together with the corresponding regulatory update that it
belongs to (see Figure 12). Tagged users can review the note and perform necessary actions for review
and impact assessment according to their user profile permissions.

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Users can click on any of the rows of the table and bring up the detailed view of the regulatory update,
from which they can add comments or make changes depending on their permissions level.

Closed tasks
This page is available only to the users with roles “Administrator” and “Supervisor”.

Regulatory updates that were closed by a user are shown in the user’s “Closed tasks” list (Figure 13). This
page contains only items that are in an “closed” status.

The page contains a Summary section, showing the total number of items closed by the user, as well as a
break-down by Group/Function, Topic, Priority and Closed by date period relative to now.

Metrics on the Summary dashboard can also be used as filters, by clicking on them to select them.
Selecting a metric, filters the list for the relevant attribute.

Regulatory updates that match the selected criteria, if any, are shown in the section below the Summary
dashboard. Users can click on any of the rows of the table and bring up the detailed view of the regulatory
update.

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Figure 13. ClaRITA My Tasks, Closed items page

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My Function(s)
This page is available only to the users with roles “Administrator” and “Supervisor”.

Regulatory updates that are assigned to a certain Group/Function for action are organized in the “My
Function(s)” list (Figure 14). This page contains only items that are assigned to the Group/Function but
not assigned to the specific Reviewer, or the items that are assigned for the Group review.

By default, the page shows only the items that are in an “open” status (New, In Progress, etc.), i.e. not
marked as “Closed” or “No action required”. Items that are in a “closed” status are displayed in the table
“Available reviews for my Function(s)” when the user presses and activates the button “Show closed
updates” in the top right corner of the page.

The page contains a Summary section, showing the total number of open items assigned to the
Group/Function, as well as a break-down by Topic, Priority and Review by date period relative to now.

Metrics on the Summary dashboard can also be used as filters, by clicking on them to select them.
Selecting a metric filters the list for the relevant attribute.

Regulatory updates that match the selected criteria, if any, are shown in the section below the Summary
dashboard. Users can click on any of the rows of the table and bring up the detailed view of the regulatory
update, from which they can add comments or make changes depending on their permissions level.

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Figure 14. ClaRITA My Tasks, My Function(s) page

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Review reminder email


This page is available only to the users with roles “Administrator” and “Supervisor”.

"Review reminder email" page (Figure 15) enables users to set alerts to remind them if documents are
nearing review target dates. User can select the frequency of the reminder emails to be set from the list
provided by the system:

 One day before Review by date


 3 days before Review by date
 5 days before Review by date
 7 days before Review by date
 10 days before Review by date
 14 days before Review by date
User can set more than one type of the reminder email to be sent.

Figure 15. ClaRITA My Tasks, Review reminder email page

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Administration

This area is only available to users with Administrator permissions.

The Administration module can be accessed via a link in the main navigation menu. This is only available
to users with Administrator permissions. Users with the roles “Supervisor” and “User” will not see this
section in the navigation bar and will not be able to access the Administration module.

Pre-publication triage
Regulatory updates are imported into the application on a daily basis from Cortellis Regulatory
Intelligence (CRI). All new content is automatically assigned a “Pending” status and is added to the Pre-
publication triage awaiting review by local Administrators who will decide whether the update is relevant
to the company and who will also perform an initial priority and impact assessment.

The main page of the pre-publication triage (Figure 16) is very similar to the Daily updates page, offering
the same sorting, search and filtering functionality but only regulatory updates available here are those
with a status:

 “Pending” or
 “Out of scope”.
The page has the same set of search and filtering fields, and quick search buttons, their functionality is
described in details in the relevant chapter above.

Pre-publication triage page also has “Download updates as Excel” button, same as Daily updates page,
that allows the user to download all the documents with metadata present on the page as an Excel file.

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Figure 16. ClaRITA Administration, Pre-publication triage page

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New document
Administrators can add regulatory updates or other relevant documents by clicking on “Create a New
Document” button.

New documents contain the following data items (Figure 17):

Title: mandatory field, up to 255 characters.

Abstract: mandatory field up to 4,000 characters.

Comments: optional field up to 4,000 characters.

Source URL: optional URL that points to the source document. This can be either an external or
internal (e.g. SharePoint) link.

Country/region: mandatory field from a controlled list of countries and regions

Posted by Authority: optional date field denoting the date that the document was originally
published.

Coming into force: optional date field denoting the date that the document comes into force, if
applicable.

Topics: mandatory field, at least one topic must be selected.

Document type: mandatory field, at least one document must be selected.

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Figure 17. ClaRITA Administration, New document form

The new document is added to the pre-publication triage with a status of “Pending”, similar to newly
ingested CRI content. Administrators can then select it from the list to complete the triage, by adjusting
the priority, review by dates, assignment and impact assessment and “publishing” it to the rest of the
users when ready.

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Detailed view and management


Clicking on one of the regulatory update cards, brings up a detailed view in a pop-up window (Figure 18).
Administrators can review the contents of the update, decide whether the alert is relevant to the business
and fill-in additional review and assessment information.

Figure 18. ClaRITA Administration, Pre-publication review

Status

All new regulatory updates imported into the system on the Pre-publication triage page are assigned by
default with the status “Pending”.

Administrator can change the status (Figure 18- ) from “Pending” to either “New” or “Out of scope”*.
Regulatory updates that are marked as “Out of scope” remain in the Pre-publication triage area and
cannot be accessed by other users of the application. Updates marked as “New” are released to Daily
updates (published) and become available to all other users.

To save changes Administrator should click “Apply all changes” button (Figure 18- ).

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*Administrator statuses are configurable, ask your Clarivate ClaRITA administrator for configuration options.

Regulatory updates marked as “New” and published after clicking “Apply all changes” button,
will be removed from the pre-publication triage area. They cannot be returned to a “Pending” or
“Out of scope” status, so attention needs to be paid to only mark as “New” items that need to be
made available to all other users.

Priority

All new Regulatory updates imported into the system on the Pre-publication triage by default are assigned
with the “No Priority” level.

Administrator can assign regulatory update with one of priorities (Figure 18- ) available in the system*
indicating the level of urgency and importance to the company. The criteria that apply to each priority
level are agreed by regulatory experts and are not pre-determined by the system.

Priority levels are indicated by both name and a corresponding color coding, which is shown as a vertical
bar on the regulatory updates card or as a colored circle in the detailed view.

To save changes Administrator should click “Apply all changes” button (Figure 18- ).

*The names, colors and number of priorities are configurable, ask your Clarivate ClaRITA administrator for configuration options.

Review date

The “Review by” date (Figure 18- ) is an internally agreed milestone that drives the department’s
performance metrics. Administrator can assign regulatory update with “Review by” date selecting the
date from the drop-down calendar.

To save changes Administrator should click “Apply all changes” button (Figure 18- ).

Adding review cycle and assigning Group/Function and Reviewer

By default, there are no reviews or impact assessment assigned to the regulatory update.

Administrator can assign regulatory update with one or more review cycle for impact assessment. To
assign Review cycle to the update Administrator should click on the button “Add review” (Figure 18- ).

The new review cycle box will appear with the fields to select relevant Group, from the list of available in
the system (Figure 19- ), and Function, from the list of available for selected Group (Figure 19- )*.

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Assigning a regulatory update to a Group/Function and publishing the update, adds the update to the “My
Function(s)” list on My tasks page for the users belonging to the selected Group and Function for follow-
up.

To trigger an email notification to the assigned Group/Function (Task assignment email), Administrator
must select the tick box “Send group assignment notification” (Figure 18- ).

To save changes Administrator should click “Apply all changes” button (Figure 18- ).

Administrator can assign a Reviewer to the update by searching for their name in the relevant field (Figure
19- ), the system will automatically recommend users belonging to the selected Group and Function.

Assigning a regulatory update to a user and publishing the update, triggers an automatic email notification
to the user (Task assignment email) and also adds the update to the user’s “To do” list for follow-up.

To save changes Administrator should click “Apply all changes” button (Figure 18- ).

While the regulatory update stays on Pre-publication triage page, Administrator can delete previously
added review cycle by clicking the “Recycle bin” button on the right side of the review cycle box. After
publishing of the regulatory update, review cycle cannot be deleted.

Administrator can add new review cycles for both documents in Pre-publication triage page, and for
already published documents displayed on Daily updates page.

*The names, and number of Groups and Functions are configurable, ask your Clarivate ClaRITA administrator for configuration options.

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Figure 19. ClaRITA Administration, Review cycle and Reviewer assignment

Impact assessment

The regulatory update’s impact to the company is assessed through Impact assessment questions
(Figure 20) that can be answered with a Yes/No answer as well as with the addition of free text
comments if required*.

While the regulatory update stays on Pre-publication triage page, Administrator cannot edit Impact
assessment questions.

*The number and wording of the impact assessment questions are configurable, ask your Clarivate ClaRITA administrator for configuration
options.

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Figure 20. ClaRITA Administration, Impact assessment

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Open items
This dashboard provides an overview of all currently open items so that Administrators can identify issues
that may require attention to ensure timely completion.

Figure 21. ClaRITA Administration, Open items dashboard

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A set of filters at the top (Figure 21- ) allows filtering of results using the following criteria:

Group/Function

Review Status

Status

Priority

Country/Region

Topic

Review by (as a relative time period to today)

The middle section of the screen (Figure 21- ) displays a set of charts that show the breakdown of open
items that match the selected criteria by Group/Function, Review Status, Status, Priority, Country/Region,
Topic and Review by dates. Changing the filtering criteria updates the charts.

The bottom part of the screen (Figure 21- ) is occupied by a table that lists the matching open items.
The table can be sorted by clicking on any of the heading cells. The tabular view can also be switched to a
timeline view by selecting the “TIMELINE” toggle (Figure 21-  and Figure 22).

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Figure 22. ClaRITA Administration, Open items dashboard, timeline view

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Closed items
This dashboard provides an overview of all closed items so that Administrators can review them.

Figure 23. ClaRITA Administration, Closed items dashboard

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A set of filters at the top (Figure 23- ) allows filtering of results using the following criteria:

Group/Function

Review Status

Status

Priority

Country/Region

Topic

Closed in (as a relative time period to today)

The middle section of the screen (Figure 23- ) displays a set of charts that show the breakdown of closed
items that match the selected criteria by Group/Function, Review Status, Status, Priority, Country/Region,
Topic and Closed by dates. Changing the filtering criteria updates the charts.

The bottom part of the screen (Figure 23- ) is occupied by a table that lists the matching closed items.
The table can be sorted by clicking on any of the heading cells. The tabular view can also be switched to a
timeline view by selecting the “TIMELINE” toggle (Figure 23- ).

Performance
Performance reports help Administrators calculate Key Performance Indicators (KPI) across the team (see
Figure 24). They also help assess individual team members workload and identify areas that require
additional resources and support.

The criteria that can be used in the reports include (Figure 24- ):

Time period: “from” and “to” dates can be chosen freely. Depending on the length of the period,
results will be shown on a daily, weekly or monthly basis

Topic

Document type

Country/Region

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Figure 24. ClaRITA Administration, Performance (KPI) Reports page

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The following KPIs are calculated:

Measure 1: Workload and review efficiency of detected relevant regulatory updates

 Total new items


 Missed review target (items closed after their review deadline)
 Average time to close (days from “New” to a closed state)
Measure 2: Regulatory updates that were communicated to targeted stakeholders

 Total new items


 Total communicated (shared, users tagged or with reviews assigned for action)
 % communicated
Measure 3: Regulatory updates that were assessed and closed

 Total new items

 Total assessed and closed (items with impact assessment and a closed status)
 % assessed and closed
Measure 4: Regulatory updates with impact analysis/assessments

 Total new items


 Total items with impact assessment
 % with impact assessment
In addition to the KPIs view, it is also possible to calculate Measure 1 for each Group that had at least one
item matching the selection criteria assigned for the group review in the time period under review. By
selecting the toggle “GROUPS” (Figure 24- ) Administrators can access this report (see Figure 25).

Selecting a Group/Function from the list shows a chart of Measure 1 for it.

It is also possible to calculate Measure 1 for each individual that had at least one item matching the
selection criteria assigned to them in the time period under review. By selecting the toggle “INDIVIDUALS”
(Figure 24- ) Administrators can access this report (see Figure 26).

Selecting a user name from the list shows a chart of Measure 1 for the selected individual.

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Figure 25. ClaRITA Administration, Performance, Groups report page

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Figure 26. ClaRITA Administration, Performance, Individuals report page

The reports can be downloaded in the PDF file format by clicking the button “Download report as PDF”
(Figure 24- ).

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User Management
Administrators are able to manage User Accounts, by adding, editing or deactivating users from the
system on the User management page (Figure 27).

Figure 27. ClaRITA Administration, User management page

To create a new user, click on “Create new user” button, fill-in the details in the relevant dialog window
and save changes using “Create user” button (Figure 28).

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Figure 28. ClaRITA Administration, Create New user form

An email will be sent to the User’s email address with instructions and a unique link that needs to be
followed for a password to be set by the user and the registration process to be completed successfully.

Make sure that the correct email is entered, as a valid email is needed for the registration process to
be completed.
Registration links expire after 24 hours.

Administrators also can add users by uploading the list of users in the Excel file on Upload users page
(Figure 29). Excel file must contain following tabs:

 User name
 User surname
 User email address

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 User role (Administrator/ Supervisor/ User)


 User status (Active/ Inactive)
Administrators can download the Excel file template using the link “Download Upload file Template”.

Figure 29. ClaRITA Administration, User upload page

Administrators also can deactivate users in the system by:

 Selecting the user in the table and clicking “Deactivate” button (Figure 30).
 From Edit user dialog window by selecting “Deactivate the user” tick box (Figure 28).
Deactivating an account keeps the user in the list of users from which it can be easily reactivated.

Figure 30. ClaRITA Administration, User account deactivation form

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Groups and Functions assignment

Administrators are able to manage user assignment to the Groups and Functions available in the system*.

To assign the user to the Group Administrator should go to the “User management” page, open the “Edit
user” dialog window from the table with the list of users and assign Groups (Figure 31- ) and Function
(Figure 31- ) to the user by selecting them in the relevant fields.

*The number and names of Groups and Functions are configurable, ask your Clarivate ClaRITA administrator for configuration options.

Figure 31. ClaRITA Administration, Edit user

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Group management
Administrators are able to manage the assignment of access to the certain documents to the Groups and
Functions available in the system.

This assignment restricts the documents access in ClaRITA for all the users belonging to the Group that is
assigned with certain document attributes, i.e. all the users added to this group (and not added to other
groups) will see in ClaRITA only the subset of documents with certain attributes assigned to this particular
group.

To assign the user Group with document attributes Administrator should go to the “Group
management” page (Figure 32). On this page Administrator can see the list of Groups and Functions
available in the system.

Figure 32. ClaRITA Administration, Edit user

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To assign the certain document attributes the Group, Administrator must open the Edit group dialog box
(Figure 33) by clicking on the relevant Group row in the table. In this dialog box Administrator can select
document attributes from the following sections:

Product category
Topic
Document type
Country/Region

Each section has "Include" and "Exclude" fields that allow to select certain attributes:

 field "Include" is the field used to list all the included attributes for documents in the Group
 field "Exclude" is the field used to list all the excluded attributes for documents in the
Group, and this field works for the overall list of selected attributes as a Boolean operator
"NOT"

Inside the one field the Boolean operator for several selected values is "OR". Between "Include" and
"Exclude" fields the Boolean operator is "AND"

To save selected changes Administrator must clicking "Update" button in the bottom of the dialog box.
"Cancel" button discards all selections.

When the field “Include” is empty, this means that no filtering is applied for the attribute, and all the
documents tagged with this attribute must be included by default.

When the field “Exclude” is empty, this means that no documents are excluded by this attribute, and all
the documents tagged with this attribute must be included by default.

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Figure 33. ClaRITA Administration, Edit group

Group filters toggle

Toggle "Group filters" is shown on the top right corner of the dashboard (Figure 34). Group filter toggle
is available only to Administrators, and it allows them to turn off and turn back on group-specific
document filtering on the following pages:

 Dashboard,
 Daily updates page,
 Pre-publication triage,
 Open items,
 Closed items,
 Performance

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When Administrator is assigned to the group, the toggle is active by default. By deactivating the toggle
Administrator switches off group-specific document filtering, for the group that he is assigned to, on the
relevant page, and by activating the toggle he turns the group-specific document filtering back.

Figure 34. ClaRITA "Group filters" toggle

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Notifications
Administrators can create Notification profiles if they wish to communicate daily or weekly digests of new
content, based on set criteria, with end users (see Figure 35). There is no limit to the number of
Notification profiles that can be created and there is no limit to the number of profiles a user can belong
to.

To create a Notification profile, Administrators will need to set the following:

Notification name: ideally the name should be indicative of the content, but there is no restriction
on that the name can be.

Frequency:

 daily digests are sent overnight (UTC),


 weekly digests are sent on Monday morning (UTC),
 bi-weekly digests are sent every Monday on even weeks of the year (UTC),
 monthly digests are sent every 1st day of the next month and include all documents for
previous month,

 quarterly digests are sent every 1st day of the next first month in the quarter and include
all documents for previous 3 months.

Status

Priority

Topic

Document type

Country/Region

Regulatory version

Administrator can deactivate selected Notification profile, i.e. the notification emails will not be sent to
the assigned to the group users, by selecting a tic box "Deactivate notification group" and clicking
"Update" button. To activate back notification group, i.e. the notification emails will be sent to the
assigned to the group users, Administrator must unselect a tic box "Deactivate notification group" and
click "Update" button.

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Administrator can delete the notification group by selecting a tick box next to the group name on the left
panel with the list of groups and click "Delete" button, after that the dialog box appears asking to confirm
or cancel the action.

Figure 35. ClaRITA Administration, Notification profile page

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Users can be assigned to notification profiles from the “User management” page, in the “Edit user” dialog
window (Figure 31- ).

Depending on the criteria used, it is likely that the same regulatory update may appear in more
than one newsletter. Users who subscribe to multiple notifications, will receive a separate email
for each one of them and may receive the same regulatory update multiple times, once in each
newsletter.

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Support
All support requests must be routed through the local application manager, who will assess the root cause
of the problem and escalate to the relevant support department. Any urgent issues can be emailed
directly to Clarivate Analytics at customer-support-clarita@clarivate.com.

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