PV Intake - Training PPT 4.5 - Updated

RxLogix Corporation
PV Intake – Training
Manual
Revisions and Approvals
Revisions
Author
and Approvals
Document ID Version Date
Aashna Mehra Meenal please fill it out Version 2.0 TBD
RxLogix Corporation, Confidential, Copyright ©2016 2

Agenda
Training Topic Duration

(minutes)
Training Overview Purpose, Scope, Outcome, & 5
Approach
PV Intake Overview
Part 1 Why use PV Intake? 10
Accessing PV Intake
Terminology
Part 2 180
Application Walkthrough
Part 3 Approaches to Frequent Use Cases 45

Purpose & Scope
Purpose
 To provide a detailed walk-through and frequent use case approaches so
trainees may independently utilize the PV Intake application.
Scope
 This training is intended for business users and SMEs who meet the
training prerequisites.
Note: This training does not include:

 Any modules available to users with administrative privileges
 Safety System field training

Outcome
Trainees will be able to perform the following tasks in PVI that include, but are
not limited to:
Case creation via Email
Case creation Manually
Perform Duplicate Search & Follow Up Processing
Source Document Management using Attachment Viewer
AE Management using listing screens
Task Management
Follow Up Correspondence
Case Distribution and Monitoring to Safety System

Training Approach
Part 1: Part 3:
Part 2:
Overview & Approaches to
Application
Basics Frequent Use
Walkthrough
Cases

Part 1: Overview & Basics
Part 1: Part 3:
Part 2:
Overview & Approaches
Application
Basics to Frequent
Walkthrough
Use Cases
PV Intake Why use PV Accessing

Overview Intake? PV Intake

1.1: PV Intake Key Features
All-in-one Case Intake solution
Automated Case Processing
Follow-up holding area
External as well as Internal Usages
Flexible Intake Form
Extensible Intake design
Multi-vigilance, Multi-lingual, Multi-tenant by design

1.2: Why Use PV Intake?
 Provides capability for companies to Intake data using any structured and
unstructured content.
 Flexibility for users to enter cases on a web-form and configure forms as per
their needs
 Ease of use for source document management as all the documents are
stored within the case making it simpler for user to extract them when
needed.
 Reduces time spent to enter data manually in Safety system
 Ability to transmit data along with source document to safety within minutes
 Minimizes the reconciliation effort between the source and safety system.

1.3: Accessing PV Intake
1. Enter PV Intake URL
2. PV Intake Log In Screen is displayed
3. Enter Username
4. Enter Password
Note: Use Google Chrome as a browser to launch PV Intake Tool

Part 2: Application Walkthrough
Part 1: Part 3:
Part 2:
Application
Basics to Frequent
Walkthrough
Use Cases
Getting
PV Intake Familiarized
Key Terminology
Walkthrough? with screens and
fields

2.1: Key Terminology
Data Source Document

AE information received/updated Any attachment received containing
in the system. AE data.
Case
A record in the system that holds AE details.

Agenda
Search Case
Case List
New Follow Up
Intake Queue
• Basic Case Entry New Case

• Full Case Entry
Tasks
• Intake Queue widget

• Case List Widget
PV Intake
Dashboard Navigation PV Admin
• Search case Widget
• Personal Statistics
• User Management
• Group Management
• Role Management
• Field Profile Management
• Privacy Location
• Audit Trail

Expand / Compress the Vertical Side Bar
Expands / compresses the

vertical side bar.

PV Intake Logo & Dashboard
Click on the PV Intake icon or

the Dashboard icon to navigate
to the Dashboard.

New Case
New Case, provides option for user to

create cases in following screens:
• Basic Case Entry
• Full Case Entry

New Follow Up
Follow Up, enables the user to create Follow ups

for the existing cases when an additional
information/update is received for the case

Search Case
Search Case enables user to search for

cases in the application and navigates
the user to duplicate search screen

Case List
This option navigates user to the Case

Listing screen with options to view,
search, filter and sort records available in
the system

Intake Queue
This option navigates user to Intake

Queue which allows user to view all
the new records available in the
system

Tasks
Tasks navigates user to Tasks

Management where users can create,
view, and manage tasks

PV Admin
Clicking on PV Admin navigates user

to PV Admin where administrator
users can access following functions:
• User Management
• Role Management
• Audit Trail
• Error logger

Dashboard
Case Creation
Follow up creation
Search Case
Case List Screen
Intake Queue
Tasks
PV Admin

Search Case
This widget provides option to search records

by typing free text here. Clicking on Search
Icon will take user to Follow up Duplicate
Search Screen

Personal Statistics
This widget explains the personal statistics of the logged

in user. It shows count of cases assigned to user in each
case state

Intake Queue
User can access Intake Queue widget from dashboard. Intake

Queue lists all the incoming record in the application

Case List
User can access Case List widget from dashboard screen. Case List
includes cases in all the case states in the application

User Preferences
Allows the user to access –

• Preferences- Clicking on Preferences will take user to
user preference page where user can change
language, themes, timezone & preferred templates.
• Help-Under help companies can configure their
training material which can open up on need basis
• Logout - This will log out the user

User Preferences contd..
On Preferences page user can select following personal preferences:

• Language- Currently by default it only allows English as preferred language
• Timezone- User can select there timezone based on there location
• UI Theme – User can change the application them by selecting one of the 3 themes
available by default
• Preferred Case Entry Template: User can select Full Case Entry or Basic Case Entry
template as per there need.

 Dashboard
• Case Creation • Basic Case Entry Screen

• Follow up creation • Full Case Entry Screen
• Search Case
• Case List Screen
• Intake Queue
• Tasks
• PV Admin

Case Creation
Cases in PV Intake application can be created using 2

default screens:
 Basic Case Entry Screen
 Full Case Entry Screen

Case Creation- Basic Case Entry Template
BCE screen has a minimum list of fields by default

which is needed for data entry. All the accordions
are open by default making it easier for the users
to navigate through the screen

Case Creation- Basic Case Entry Screen
BCE screen provides user with the secondary view

where users can select the fields on need basis

Case Creation- Basic Case Entry Template
 Dashboard
• Case Creation  Basic Case Entry Screen
• Follow up creation & Duplicate • Full Case Entry Screen

Search
• Search Case
• Intake Queue
• Tasks
• PV Admin

Case Creation- Full Case Entry Template
• FCE screen is a screen which includes additional fields than what is on

BCE Screen
• The base list includes all the E2B R3 fields out of the box with some
additional administrative fields
• By default only one section is open at a time which helps user to
perform focused data entry

FCE Screen provides Tree-view navigation

pane and clicking on section name navigates
user to that section.

User can add and reorder
records using these icons
for the repeatable sections.
2
1
3
Repeatable Sections: Following sections in the
User can remove the
application allows adding multiple records.
records using this icon for
• Reporter(s) the repeatable sections
• Literature(s)
• Event(s)
• Test(s)
• Product(s)
• Attachment(s)

Tree view displays main sections and sub-sections or record

under them as a parent child link. Clicking on ‘+’ icon will
expand the list of sub-section and display the names of the
records

RxLogix Corporation
Common Features
Case Creation – Create Button
Clicking on Create button,

creates the case

Case Creation – Update Button
Clicking on update button, updates

the existing case.

Case Creation - Indicators
By default following are the values of these fields:

• Intake Case: N/A
• Version: Initial
• State: N/A
• Assigned To:
o By Default when user opens case entry form the Assigned To value
is defaulted to the logged in User
o For cases created via email by default it is left ‘unassigned’ unless
auto-assignment is turned on.

Case Creation – Auto-Generated values
Once the case is created following

fields are auto-generated
• Intake Case number
• State

Case Creation – Mandatory Icons
1
2
Red dots on section name
indicates mandatory section Red dot next to fields
indicate mandatory field
Orange dot next to fields indicate

mandatory sets i.e. one of the field shall
3 be present in that section

Case Creation – Warning Message
Warning message is displayed if any of the mandatory sections,

fields or mandatory set fields are missing data while creating or
updating a case

Case Creation - Actions
Clicking on actions button

enable the user to perform
following actions on case
Entry Screen :
• Accept
• Reject
• Transmit
• Mark as Closed
• Add FU Query
• Accept as Follow Up
• FU/Dup Search
• Split
• Copy
• Add Task

Case Creation- Actions Accept
Clicking on Accept Button, changes the state of the

case.
A success message is displayed stating case change*
From State: NEW Active

Case Creation- Actions Reject
Clicking on Reject, enables a Rejection justification box were user

will have to enter comments, username and their password for
Rejecting a record

Case Creation- Actions Reject
Once the state of the case is changed system gives

successful notification state is changed to Rejected

Case Creation- Actions Transmit
Clicking on Transmit button displays a warning

message

Case Creation- Actions Transmit
• After clicking on Transmit the success message is displayed stating case is

marked for transmission.
• The record is delivered to Safety system using E2B R3, E2B+ or PDF file
whichever method is chosen by the company

Case Creation- Actions Mark as Closed
Clicking on Mark as Closed, enables a Case Closure

justification box were user will have to enter comments,
username and their password for Marking the case as closed.

Case Creation- Actions Mark as Closed
Once the state of the case is changed system gives

successful notification state is changed to Closed

Case Creation- Actions Add FU Query
4 5
2
3
6
7 10 1
8
9
11

10
Clicking on Help icon opens this modal

# Description
1 Clicking on Add FU enables the Follow Up Query Email Modal
2 User can select Method of follow up query from the dropdown. By default system provides
option of selecting Email, Fax, Telephone and Letter
3 User can add reporter email address or the Primary recipient to whom the follow up query
needs to be sent
4 User can check the cc options which will allow user to add any additional recipient to whom the
carbon copy of the follow up query needs to be sent
5 User can check the Bcc options which will allow user to add any additional recipient to whom
the Blind carbon copy of the follow up query needs to be sent
6 User can select any preconfigured letter templates which could be used to send a follow up
query template and modify the templates as per there needs
7 User can enter subject of the email follow up query email which will be sent to the reporter. If a
subject is configured for preconfigured letter template it will be auto-populated in this field
8 Message field provides user to enter the text which needs to be part of the email body which
will be sent to the reporter
9 This option provides user to format body of the email message

# Description
10 Clicking on help icon opens list of field tags supported in email body and subject which will
be auto-populated with actual data from the case in an outgoing query
11 • Create: Clicking on send will send the follow up query to the reporter
• Cancel: Clicking on cancel will cancel this action
• Reset: Clicking on Reset will empty all the entered fields

Case Creation- Actions Accept as Follow Up

Case Creation- Actions Accept as Follow UP
5 6 7

# Description
1 Clicking on Action-> Accepts as Follow Up enables the pop-up window
2 User can enter the Initial case # to which the follow up needs to be accepted
3 Clicking on Ok performs the action of Accepting the record as Follow up to Initial
case
4 Once the action is completed system displays the success message stating that
case has been Accepted as Follow Up
5 The system updates the Intake case # to the same as of Initial case #
6 System changes the version of case to Follow Up #1
7 System changes the state of the case to Active

Case Creation- Actions FUP/Dup Search
Clicking on FUP/Dup search, navigates user to Follow Up / Duplicate

search screen and auto-populates the available data on the search grid
for the fields present on Duplicate search screen

Case Creation- Actions Split
2
3


# Description
1 Clicking on Action-> Split enables the split pop up window
2 User can enter how many cases they would like to split the case into?
3 Clicking on Ok gives user split window with list of files
4 User can then move attachment based on how many separate cases they would
like to create
5 Clicking on Create creates the separate cases along with the attachments
6 System performs the Split action and creates the new case

Case Creation- Actions Copy
On Clicking Copy system gives the warning message

indicating that if a copy of the case needs to be created

Case Creation- Actions Copy
On performing Copy actions system will copy the entire data from the
previous case and will create a record and open the case in case
entry form

Case Creation- Actions Add Task
2 3 4
5 6 7
8
9
10 1

Case Creation- Actions Add Task
# Description
1 Clicking on Action-> Add Task enables the Create Task window
2 User can select Task type field depending on which task they have to create
3 User can assign Priority to the task which will be created by them
4 User can assign the task to team member by selecting the username from this field
5 User can set a Due Date for the completion of task
6 Once user marks the status as completed system will auto-populate the completion
date
7 User can change the status of the task from this field
8 User can fill the description of the task in this field
9 Checking this check box will trigger an email alert to Assigned to user. If the priority of
the task is set to High, then system will automatically check this box
10 • Create: Clicking on this will create the task
• Cancel: Clicking on Cancel will close the window

Case Creation
Clicking on view button enable the user to view the following views:
• View E2b: Clicking on view e2b shows the case data in the simple XML
format
• FU Diff View: Clicking on FU Diff View will open the case in FU Diff view with
the changes highlighted between the two versions
• PDF view: Clicking on PDF view generates and downloads the PDF on users'
machine

Case Creation View E2B

Case Creation FU Diff View
• FU Diff View will show changes between the versions

• Any additions will be highlighted in green text
• Any updates or removals will be displayed as strikethrough using
red text

Case Creation PDF View
PDF View will display the case entry screen in the PDF format

RxLogix Corporation
Attachment Viewer
Case Creation – Attachment Viewer
Display Attachments icon is available to display

source documents. By default it will be checked
Source documents available in the case will be

available under attachments section

Once the user clicks on attachment icon, the

screen is converted in 60-40% ratio and opens the
the attachment in case

Multiple attachments are listed one below the other in the attachment
viewer, clicking on each open's respective attachment .

1 2 3 7
4 5 6 8 9
10 11

# Icon Description
1 This enables a search option and allows user to search text in the source
document
2 This option allows users to add annotation to the source document
3 This option allow user to redact information on the source document
4 Clicking on this option shows the source document in thumbnail view
5 Clicking on this option will rotate the page of the source document
6 Clicking on this option will rotate all the pages of the source document
7 Pagination option which provides user to navigate from one page to another
8 Clicking on this option enables the print the source document

9 Clicking on this option downloads the source document on the local machine
10 Clicking on this option enables the text selection option which will allow user to
copy and paste content of source document
11 This option allows user to zoom in and out of the source document

Dashboard
Case Creation
• Follow up creation
• Search Case
• Intake Queue
• Tasks
• PV Admin

Follow up creation

Follow up creation
2
*
3

Follow up creation
5 6 7

# Description
1 Clicking on New Follow up enables the pop-up window
2 User can enter the Initial case # to which the follow up needs to be accepted
3 Clicking on Ok performs the action of Accepting the record as Follow up to
Initial case
4 Once the action is completed system displays the success message stating that
case has been Accepted as Follow Up
5 The system updates the Intake case # to the same as of Initial case #
6 System changes the version of case to Follow Up #1
7 System changes the state of the case to Active

• Dashboard
• Case Creation
• Search Case
• Intake Queue
• Tasks
• PV Admin

Search Case
Clicking on Search Option navigates

user to Follow Up duplicate search
screen

Search Case -> Follow Up Duplicate search
User can enter unstructured text to perform the duplicate

search based on the matching criteria

In search case widget on follow up duplicate search screen user can perform
structured search by entering data in any of the available field

User can add additional fields from the secondary view, on need
basis to modify the search criteria and identify duplicate cases

User can add additional fields from the secondary view, on need
basis to modify the search criteria and identify duplicate cases

Search Case Follow Up Duplicate search
1 2 3
4 5

Search Case Follow Up Duplicate Search
# Description
1 User can select Date Range Type filter to perform search for the cases
2 User can select Date Range on which they will like to perform search for
duplicates
3 User can perform search on Intake DB, Safety DB or both
4 Safety Case # columns display ‘safety case #’ and once user clicks on the number
safety case version of that case will open in ‘Read only’ view
5 Safety Workflow Column display the workflow of the case in Safety System

• Dashboard
• Case Creation
• Search Case
• Intake Queue
• Tasks
• PV Admin

Case List
This option navigates user to the Case Listing

screen with options to view, search, filter and sort
records available on the case list screen

Case List
Case Listing Screen displays all the cases which are available in the system

• Dashboard
• Case Creation
• Search Case
• Intake Queue
• Tasks
• PV Admin

Intake Queue
This option navigates user to the Intake Queue screen

with options to view, search, filter and sort records
available in the system

Intake Queue
Intake Queue displays only New and

Active cases in the application

• Dashboard
• Case Creation
• Search Case
• Intake Queue
• Tasks
• PV Admin

Tasks
Clicking on Task navigates user to Tasks Page

Tasks
Task page displays all the tasks which are available in the system

RxLogix Corporation
Common Features on Listing and Task

Screens
Common Features on Listing Screens
1 2 3
5
4
6 7 8 9 10
11
12

13 15
16
14

# Description
1 The Search Cases Text box is used to search cases using Intake Case #, Event, Product, Study
Number, Study Number and Assigned To fields
2 The Date Range Type filter allows user to select the date range type which is First Receipt Date
and FU Receipt Date
3 The Date Range filter allows user to select range on which search needs to be performed
4 Include Case criteria allows user to select on which case state user will like to perform search
on
5 Clicking on Search button performs the search
6 My cases shows the cases which are assigned to the user
7 All cases shows the list of all the cases available in the application
8 Clicking on display options allows user to select how many records they would like to display on
screen
9 Clicking on this icon export the case listing which is visible on the screen into an excel
10 Clicking on this icon enables the filtering option on the screen on the primary view
11 Clicking on this icon applies the sorting on that column

# Description
12 Click on this icon will enable the Primary, Secondary and Optional View
13 This view allows user to select whichever fields they would like to display on Primary,
Secondary and Optional view
14 This options allows user to navigate from one page to another
15 Clicking on this icon enables Action Menu
16 Clicking on this icon enables View Menu

• Dashboard
• Case Creation
• Search Case
• Intake Queue
• Tasks
• PV Admin

PV Admin
• User Management
• Role Management
• Audit Trail
• Error logger

PV Admin
• User Management
• Role Management
• Audit Trail
• Error logger

PV Admin – User Management
1 2 3

• User can search for a user using username, role,

language, email, user group, time zone and
enabled/disabled users.
• All matching results are displayed after clicking on search.

• User can create a new user by adding User Type, User

name, & Privacy Location
• Roles can be assigned to the user based on the
business functions from Roles Section

User can import the LDAP users via excel to create users in bulk.

PV Admin – User Group Management
User can create new group * or

can view/edit existing groups.

PV Admin – Role Management
User can be assigned different roles

from this screen

PV Admin – Role Management
Roles assigned to users can be

viewed on role management screen.

PII Security
Field Profile Privacy Location Users

• Define what
• Define fields countries should see • Link users to
which cases? Privacy
which are PII
• Assign field profile to Location
fields?
privacy location

PV Admin – Field Profile Management
User can create field profile from this

page for PII Security

PV Admin – Field Profile Management
User can configure the fields which are

require for PII Security

PV Admin – Privacy Location Management
User can create Privacy location from

this option

PV Admin – Privacy Location Management
User can edit the privacy location by

adding/deleting countries from the
privacy location.

PV Admin – Audit Log
Audit log allows administrator to view all the

actions which are performed in the application

PV Admin – Error Log
Error log displays all the errors which

are logged in the application

Part 3: Approaches to Frequent Use cases
Part 1: Part 3:
Part 2:
Application
Basics to Frequent
Walkthrough
Use Cases

Key Use Cases
Creation of Transmission Follow Up

Creation of
Follow up to Safety via Corresponde
Initial Case
Case E2B nce
Task Manual AE Duplicate Search

Management Intake on Safety Data
Audit Log

PV Intake - Training PPT 4.5 - Updated

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RxLogix Corporation

Aashna Mehra Meenal please fill it out Version 2.0 TBD

RxLogix Corporation, Confidential, Copyright ©2016 2

Training Topic Duration

RxLogix Corporation, Confidential, Copyright ©2016 3

Note: This training does not include:

RxLogix Corporation, Confidential, Copyright ©2016 4

RxLogix Corporation, Confidential, Copyright ©2016 5

RxLogix Corporation, Confidential, Copyright ©2016 6

PV Intake Why use PV Accessing

RxLogix Corporation, Confidential, Copyright ©2016 7

All-in-one Case Intake solution

Automated Case Processing

Follow-up holding area

External as well as Internal Usages

Flexible Intake Form

Extensible Intake design

Multi-vigilance, Multi-lingual, Multi-tenant by design

RxLogix Corporation, Confidential, Copyright ©2016 8

RxLogix Corporation, Confidential, Copyright ©2016 9

1. Enter PV Intake URL

2. PV Intake Log In Screen is displayed

Note: Use Google Chrome as a browser to launch PV Intake Tool

RxLogix Corporation, Confidential, Copyright ©2016 10

RxLogix Corporation, Confidential, Copyright ©2016 11

Data Source Document

A record in the system that holds AE details.

RxLogix Corporation, Confidential, Copyright ©2016 12

• Basic Case Entry New Case

• Intake Queue widget

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Expands / compresses the

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Click on the PV Intake icon or

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New Case, provides option for user to

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Follow Up, enables the user to create Follow ups

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Search Case enables user to search for

RxLogix Corporation, Confidential, Copyright ©2016 18

This option navigates user to the Case

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This option navigates user to Intake

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Tasks navigates user to Tasks

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Clicking on PV Admin navigates user

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This widget provides option to search records

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This widget explains the personal statistics of the logged

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User can access Intake Queue widget from dashboard. Intake

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Allows the user to access –

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On Preferences page user can select following personal preferences:

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• Case Creation • Basic Case Entry Screen

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