ARGUS SAFETY BASICS

ARGUS SAFETY BASICS

 To login, enter your username and
password in the Argus Safety login
screen.
 To logout, click [Logout] in the
upper right corner of the
application.
 The Personal Argus
Status page allows you
to view and access items
such as Cases assigned
to the user, contact log
entries, and action
items.
 Go to Utilities ->
Personal Argus Status
to access the items that
are personally assigned
to the user.
 If you know the case
number, you can also
open cases from this
page as well entering
the case number in the
Case Quick Launch field
and clicking [Open]
QUICK LAUNCH ICONS

Icon Tool Tip Description

New Case from Image Displays a new case from an image.
New Case Displays the Initial Case Entry dialog. This is similar to performing Case Actions - New Case.
Open Case Displays the Case Search dialog. This is similar to performing Case Actions - Open Case.
Displays the Worklist dialog. This is similar to performing Worklist - XXX option.
Worklist
Note: XXX is defined within the User Configuration for the default Worklist option. If no default Worklist option is
defined, then Worklist - New is displayed.
Close Case Performs the same functionality as Case Actions - Close Case.
Print Case Displays the Case Print dialog. This is similar to performing Case Actions - Print Case.
Save Case Saves the case with any changes made.
Forward Case Displays the Case Routing dialog and enables you to forward the case.
Return Case Displays the Case Routing dialog and enables you to return the case.
Displays the Case Lock or Case Unlock dialog. This is similar to performing Locking or Unlocking Cases in the
Lock Case
Activities Tab.
Medical Review Displays the Medical Review dialog. This is similar to performing Case Actions - Medical Review.
Coding Review Displays the Coding Review dialog. This is similar to performing Case Actions - Coding Review.
Draft Report Displays the Report List of All the Expedited Reports. This is similar to selecting View Draft Report.
Performs the function that prints the E2B Report &endash; DTD Length Check Warnings and E2B report &endash;
E2B Check
DTD Validation.
Validation Check Performs case validation.
MENU NAVIGATION

Menu Options
Menu Options Description
Active Cases are cases that are currently open by you
or have recently been opened (Last Accessed Cases).
Active Cases The system logs any cases you view in the active case
list. Move the mouse over the Active Cases option to
view the case numbers.
A key function in Argus Safety to help manage “New”
Worklist or “Open” cases, “Reports” pending submission or
distribution, or open action items.
Actions that can enable you to open or create cases or
Case Actions actions that may be performed on the case that is
currently open by you.
Access several different kinds of reports such as
Compliance, Aggregate Reports (e.g. Line Listings,
Reports
Case Data Analysis), Periodic Reports, and Bulk
Reporting.
Provides utilities such as launching the MedDRA
browser, viewing the User Login List, or viewing Logs
Utilities
(the audit trail information for cases or configuration
changes).
Provides dashboards on key performance areas such Separate Argus Modules
Dashboards as case workload, reports due soon or number of
cases in the workflow.
If you have administrative permissions, you will have
Argus Console this menu option available to make configuration
changes in the Argus Safety system.
If you have the appropriate user permissions, you will
Argus Insight have this menu option available to launch the Argus
Insight module.
CASE FORM TAB NAVIGATION

Case Form Tab Navigation

General Tab Products Tab Activities

Report Type Product Information Contact Log
Follow-up dates Product Indication Action Items
Study Information Dosage Regimens Routing Comments
Literature Information Product details Case Lock/Archive
Reporter Information
Events Tab Additional Info
Patient Tab Event Information Notes and Attachment
Event Coding
Patient Information References
Event Seriousness Criteria
Patient Details
Event Details
Pregnancy Information Regulatory Reports
Event Assessment
Other Relevant History Reports: Expedited &
Product Event Details Periodic
Patient Lab Data
Parent Information
Analysis
Narratives
Case Summary
CASE ACTIONS
CASE BOOK-IN
 A case is received into the Pharmacovigilance group and a Data Entry user
proceeds to enter a case based on the Reporter‘s source documentation
 Duplicate searches are performed in the Initial Case Entry screen to search
for existing cases in Argus Safety.
- The system checks for existing case information to help ensure duplicate
cases are not entered into Argus, but rather processed as a follow-up if
applicable
 The Case is Booked-In once all minimum information is recorded such as
event, patient, product, reporter, Reported Causality, Seriousness Criteria
have been completed and the case is ―Book-In‖ and the case is routed to the
next workflow state
Entering an initial case
 Case Actions > New or
click the [Case Open] icon
- Enter the following
values to find any
duplicate cases before
performing a duplicate
search: Report Type,
Country, Product, and
Event.
- Patient and Reporter
information can be
entered as well.
- For Clinical Trial cases
type protocol number
and Investigator site ID.
 Select [Search] to perform
a duplicate check
- If duplicate case is
found, new data can be
entered directly
- If no duplicate case is
found select [Continue]
button to continue
„book-in‟.
 Continue Booking-In
the remaining case
data in the Initial
Case Entry screen
ensuring that the
required fields are
completed
 Book-in - Entering an
initial case
-Mandatory fields
- Initial Receipt
date
- Country
- Report Type
- Product Name
- Description as
Reported
- Seriousness
criteria
 Select [Book-In] to
save the case in
Argus.
Entering an initial case
 Once case is booked-in
a new case number is
provided and the User
can either
- Open case and
continue with Data
entry (if they have
the appropriate user
permissions)
- Close the case
Entering an initial or
follow-up case from a
scanned image
 Case Actions > New
Case from Image or
click the quick icon
 A New Case Image
Selection dialog will
appear from which an
image can be selected
-The list contains the
image filename, file
size and date
modified
 Highlight the row with
the image and click
[Select] to use that
image for your case
book-in
 The Initial Case Entry screen is presented with a side view of the image for ease
of data entry
 The image is automatically attached to the case
- Located under attachments after you duplicate search is performed and
[Continue] is clicked
- Located in the Additional Info tab after case has been created
 OPEN A CASE
 A case can be opened from any screen throughout Argus by selecting
- Case Actions > Open or click the [Open Case] icon
 To open a case, click the case number hyperlink which can be accessed from various screens such as Case
Open, Worklist, Book-in, Personal Argus Status
 Cases can also be opened from the Active Cases menu or [Latest Accessed Cases] within the Active Cases
menu
CASE QUERYING
 Searching a case can be
performed in the Case
Open page by navigating
to:
-Case Actions > Open
or
- Click the [Open Case]
icon
 Search for a case using
the following criteria:
- Specific data (Case
Number, Event Term,
Project ID, Study ID,
etc.)
Argus Tip - Date range

• You can utilize a wildcard search by using ―%‖ around characters you are
- Product Family
querying. For example: Event Term: ―%pain‖ will find terms that - Advanced Conditions
contain pain and find terms like neck pain.
(complex queries)
CASE SAVING
 To save an opened
case, click
-Case Actions >
Save or
- Click the [Save
Case] icon
 After saving, the
system will
confirm that the
case was saved
successfully.
MEDICAL REVIEW
 The Medical Review
is typically utilized by
the Medical Reviewer
and can be accessed
by :
- Case Actions >
Medical Review
- Click the [Medical
Review] icon

 Medical Review page provides a

summary view for editing
- Case Narrative
- Case and Event Level
Assessments
 Temporal View page provides a
graphical view of the treatment
as it relates to the time the
event occurred.
- The information displayed in
the Temporal View is
obtained from case details
entered on the Case Form
PRINT CASE
 Print the Case Form while in an active case
via:
- Case Action > Print > Case Form
- Click the [Print Case] icon
 The Print Case dialog appears to select the
Case Form sections to print
- Click [Select All] or select the Case Form
options to print
- Click [Print] to open a PDF.
MEDICAL SUMMARY PRINT
 To open the Medical Summary
report for an active case:
- Case Actions > Print > Medical
Review
- A PDF document with the
Medical Summary will be
displayed for printing or saving a
soft copy

Argus Tip

•It is also possible to view the Medical Summary

directly from the Worklist New or Worklist Open by
right-clicking on the desired case row and selecting
Medical Review from the pop-up menu.
CASE REVISIONS

 Audit log history can be viewed for an

active case by accessing Case Actions >
Case Revisions
 The Case Details dialog will appear, expand
the Revisions tree and click the [Revision
History] row to view the Audit Log Details
page
 To view a previous version, simply click the
version number in the Case Details page
under Revisions and the version will open
as Read-only
VALIDATION CHECK
 Field validations are used
to define Exceptions
(Warnings and/or Errors)
to be highlighted during
Data Entry
 To run a Validation Check,
save the case and
- Click Validation Check
icon and if there
are validations an dot
Orange for Warnings or
Red for Error will
appear following the
Case Form Validations
dialog with the
exception message
Argus Tip
 Field warnings will not
prevent further case
• You can also double-click the orange or red processing and you must
dot to view the case form validations either
at the Case Status or field level (expect for resolve errors before
User-Defined fields). saving a case
 CLOSING A CASE
 In order to close an active case,
- Click Case Actions > Close
- Click the [Close Case] icon
 Closing a case does not change the case status to ―Closed,‖ it simply closes the Case
Form and removes the case from the Active Cases list.
- If you have not saved the case before you close, the system will prompt you to save the case.
- The system may prompt to route the case upon closing. Click [Cancel] to close the Routing dialog
if the case is not ready to be routed or does not need to be routed.
ACTIVE CASES
 You can quickly reopen
cases you viewed or worked
on previously by using the
[Active Cases] menu.
 When a case is already
open by the user, a list will
appear in [Active Cases]
menu as shown.
 Only 10 cases are kept
active in the Active Cases >
Last Accessed Cases menu.
CASE PROCESSING
DATA ENTRY OVERVIEW
 Once a case has been booked-in or saved, the case is auto-forwarded to the initial workflow state
typically ―Case Triage‖ workflow state after book-in.
 All information entered when the case was booked-in is carried over to the Case Form where the
Case Number and the Case Status is displayed for the case.
 Now the case is available for case processing, the user groups will perform their assigned
activities to complete the case and report to regulatory authorities.
 All additional case details can be entered based on the source documentation
DATA ENTRY GENERAL TAB
 The General Tab
captures the following
data:
- Case Number
- Report Type
- Country
- Receipt Dates
- Case Classifications
- Follow-up
Information (if
necessary)
- Study Information
(if a Clinical Trial
Report Type)
- Literature
Information (Not
shown - if a
Literature Report
Type)
- Reporter
Information
 Almost all fields in the
General Tab can be
entered via direct typing
or drop-down menus
GENERAL TAB/ STUDY INFORMATION
 The Study Information
section is available when a
Clinical Trial-related
Report Type is selected in
the General Tab.
- The Study can be
looked up from a pre-
configured Study list
by clicking the [Select]
button which pops up
a selection dialog.
- Only one study can be
selected per case.
Select a project and
click on the study and
press [Select]. To
cancel out the dialog,
click [Cancel] to return
to the General Tab.
 The Study will populate
the Study Information
fields and it will also add
the product to the Product
Tab - Product Information
section
GENERAL TAB/ REPORTER INFORMATION
 A case must have a Primary Reporter and can
have multiple reporters for a case.
- Reporter Information can be entered
manually or selected from a pre-configured
list via the Reporter Lookup window which
is accessed by clicking on [Select].
- To create an additional reporter, click on
the [New] tab of the Reporter Information
section. Manually enter or select a reporter.
 Multiple reporters are accessed by the tabs
along the bottom of the Reporter Information
section

 Report Look-up
- To select a reporter from the
Reporter Lookup window, enter
search criteria and click
[Search].
- All reporters with matching
information will be listed in the
bottom section.
- Select the correct reporter and
click [Select] to populate the
Reporter Information section
with the reporter.
- If the correct reporter is not
listed, click [Cancel] to return to
the General Tab.
DATA ENTRY PATIENT TAB
 The Patient tab is divided into
Patient and Parent sub-tabs
 The Patient Tab captures the
following information:
General patient
-
information including
patient ID, name, and
address and able to protect
patient‘s confidentiality
- Patient details including
DOB, ethnicity, occupation,
height, weight, and gender
- Other relevant medical
history
- Any related laboratory data
- Any relevant tests that
have been performed
(section not shown)
 Almost all patient data can be
entered via direct text data
entry, type ahead, or via drop-
down menu
PATIENT TAB/ PATIENT INFO
 The Patient tab is divided into
Patient and Parent sub-tabs
 The Patient Tab captures the
following information:
General patient
-
information including
patient ID, name, and
address and able to protect
patient‘s confidentiality
- Patient details including
DOB, ethnicity, occupation,
height, weight, and gender
- Other relevant medical
history
- Any related laboratory data
- Any relevant tests that
have been performed
(section not shown)
 Almost all patient data can be
entered via direct text data
entry, type ahead, or via drop-
down menu
PATIENT TAB/ PATIENT INFO
 Entering Pregnancy
Information
- If the patient
Gender = ―Female‖
and Pregnant =
―Yes‖, a section will
appear on the screen
to capture any
pregnancy
information if it is
available
- The Pregnancy
Information section
captures the
patient‘s due date,
weeks at onset or
exposure, trimester
of exposure, number
of fetuses, and
delivery information
- In the event of a
multiple birth,
additional neonate
information is
captured in separate
neonate tabs
 PATIENT TAB/ PATIENT INFO
 The Other Relevant History section captures any past medical history of the patient that is relevant to the case
 This information is used during medical reviews and contains the following:
- The Start and Stop Dates of the past event as well if the event is ongoing
- The Condition Type (type ahead or double-click on the field to display the drop-down list)
- Verbatim description of the event, the encoded Condition (PT, LLT), the encoded Indication (PT), and
encoded Reaction (PT), and any related notes

 Event Coding via MedDRA Browser

- Clicking [Encode] opens the MedDRA Browser
allowing the user to select the correct term
- The selected term and its hierarchy is then
populated in the coded fields of the Other
Relevant History section
- The green check indicates a validated
encoding
PATIENT TAB/ PARENT INFO
 The ―Parent‖ tab within
the Patient module
contains the following
information for the parent
of the patient if it is
available
- General parent
information including
the parent‘s initials,
DOB, Gender, and
Medical History
- Any other relevant
medical history of the
parent
- If the Parent Gender
= ―Female‖, the
pregnancy related
fields will editable
and the Pregnancy
Information section
will be displayed
 The ―Other Relevant
History‖ section for the
parent is populated using
the same procedure as for
the patient
DATA ENTRY PRODUCTS TAB
 The Products Tab captures all product
information related to drugs, devices, or
vaccines associated with the case
 Each product can be assigned as a drug,
device, or vaccine
 Each product tab is labeled with specific
information about the product on the case
to help the user quickly understand that
product type
 Quality Control information can also be
captured within the Products Tab by
clicking [QC Info]
 The following Drug information is
captured within the Products Tab
- General product information
including trade name, generic name,
drug code, formulation and
manufacturer coded by the Company
Product or WHO Drug Dictionaries
- Reported and coded product
indications
- Dosage regimen details
- Multiple dosage regimens are
captured in each dosage regimen tab
- Product Details including dosage
information, dechallenge and
rechallenge results, and any actions
that were taken
PRODUCTS TAB/ DRUG INFO
 The product entered
during Initial Case
Entry is available in
the Products tab
 A product may either
be a Company Product
(coded to Company
Products Dictionary) or
a Non-company
Product (coded to WHO
Drug Dictionary)
 Additional products can
be added by selecting
the (New) tab and
selecting the
appropriate dictionary
button by:
- Search for
company products
via the [Company
Products] screen
- Search for non-
company products
listed in the WHO
drug dictionary via
the [WHO Drugs]
screen
 PRODUCT TAB/ DRUG INFO
 The yellow ―DR‖ indicates that product is a Drug and the yellow ―S‖ signifies the
product is a suspect drug. This allows the end-user to quickly understand the
product type which becomes particularly helpful with multiple products on a case.
DATA ENTRY EVENTS TAB
 The Events tab is divided to capture both
[Event] and [Event Assessment] information
 A single event is added to a case during Book
In.
 Additional events may be added manually
during case processing by clicking the (New)
tab and entering all of the relevant event
information
 The [Event] sub-tab captures general event
information, event coding, the seriousness
criteria, the nature of the event, and additional
details
 The event entered at Case Book-In is carried
through to the Event section of the Events Tab
and is encoded to the following (if available):
- System Organ Class (SOC)
- High Level Group Term (HLGT)
- High Level Term (HLT)
- Preferred Term (PT)
- Lower Level Term (LLT)
- Synonym
 The Event details entered at book-in can be
edited via direct data entry
- For a new description to be coded, click
[Encode] to populate the Event Coding
section fields
EVENT TAB/ EVENT INFO
Event Coding
 The ―Description as Reported‖ is the term from
the Reporter which describes an adverse event.
It will auto-populate the ―Description to be
Coded‖ field and attempt to automatically
encode the MedDRA term.
 The ―Description to be Coded‖ value can be
manually overridden or entered to code the
term. If the term is not auto-coded signified by
a green check in the Event Coding section,
click [Encode] to manually code the term
 The MedDRA Browser will be displayed.
Select the appropriate term to code the event.
 Once coded, it will assigned terms for each
level of the SOC, HLGT, HLT, PT, and LLT in
the Event Coding section.
EVENT TAB/ EVENT INFO
Event Death Details
 If the Seriousness Criteria of ―Death‖ is checked, the
Event Death [Details] dialog opens automatically and
the ―Outcome of Event‖ field auto-populates with the
value ―Fatal‖
 Enter the ―Death Date‖, whether an Autopsy was
performed and whether Autopsy results are available
 Enter and code terms to describe the cause of death
and/or the autopsy result. If the same term is reported
as a cause of death and as an autopsy result, enter and
code a record for each term type.
 When data is entered into this dialog, the Details
button next to the ‗Death‘ checkbox will contain lines,
indicating there is additional data
Event Hospitalization Details
 If the Seriousness Criteria of ―Hospitalized‖ is checked,
the Hospitalization [Details] dialog opens automatically
 Enter the Hospitalization information (dates, duration
and appropriate tick boxes if known) and click the [OK]
button
 If data is entered into the Hospitalization details, the
[Details] button next to the checkbox will contain lines
for your reference.
EVENTS TAB/ EVENT ASSESSMENT
 The Event Assessment tab enables you to capture causality and listedness information for the company suspect
products against each of the events in a case.
 The Event Assessment tab contains Causality and Listedness information for every product-event combination
 Click the plus sign in the Datasheet column header to display the License column (each license is assigned 1
Datasheet)
 Select a ―As Reported Causality‖ value and the ―As Determined Causality‖ field will auto-populate with the
same value
- As Reported Causality‖ and ―As Determined Causality‖ fields are color coded green or red according to the
potential for reporting (red for reportable; green for not reportable)
 The As Determined Listedness is populated by the system but can be changed using the dropdown boxes
 The [Recalculate] button refreshes the data in the Event Assessment tab unless the value was previously
overwritten
DATA ENTRY ANALYSIS TAB
 The [Case Analysis] Tab
provides the ability create a
case narrative, enter an
abbreviated narrative (for
PSUR), and Case and
Company Comments as well
as a Case Summary section
 Abbreviated Narrative data is
printed on Periodic Safety
Update Report (PSUR)
reports
 Case Comment prints on the
CIOMS-I and US FDA
MedWatch reports following
the Narrative section
 Company Comment do not
appear on expedited reports
but are displayed as Sender‘s
Comments in E2b
 Case Summary is your case
level assessments and
calculated based on the event
level assessments which can
be adjusted.
ANALYSIS TAB/ CASE ANALYSIS
Narrative Creation
 Type in the Narrative field
to add the narrative
information manually.
For enhanced editing, click
on the [Binocular] icon to
enlarge the narrative field.
A new window opens that
allows you can adjust the
font size and perform a
spell check.
 Auto Narrative
functionality enables users
to generate an automated
narrative based on
configuration.
 Click [Generate] to launch
the Narrative Template
dialog and select a
template.
 You can [Append] to
existing text or [Replace]
the contents entirely in
the Narrative field
 ANALYSIS TAB/ CASE ANALYSIS
Case Level Assessments
 The Case Summary section reflects the case level assessments which may differ from the event
level assessments
 The ―Case Serious‖ field is calculated based on the event seriousness for each event
 The ―Company Agent Causal‖ is calculated using the ―As Reported Causality‖ and ―As
Determined Causality‖ fields in the Event Assessment tab
 The ―Listedness Determination‖ is calculated using the Event Assessment ‗Listedness‘ fields
 The ―Case Outcome‖ is calculated using the ―Event Outcome‖ field from all the events
 The ―Company Diagnosis/Syndrome‖ is manually populated and coded to MedDRA
 All of these fields can be overwritten and when doing so will prompt for a justification for the
override which are populated in the corresponding ―Notes‖ field
ANALYSIS TAB/ MEDWATCH INFO
 The [MedWatch Info]
tab enables you to
enter additional
details required for
the MedWatch 3500A
Drug Report
 The MedWatch
Information is printed
on the MedWatch
reports submitted to
the US FDA
 Report Source fields
are populated based
on Country (Foreign),
Report Type
(Literature / Study)
and Reporter Type /
Health Professional
values
 ANALYSIS TAB/ AFSSAPS INFO
 The [AFSSaPS Info] tab wit enables users to capture information that is
exclusive to the French AFSSaPS report form
 AFSSaPS information is required to calculate the Imputability score which is
either included on the printed forms or provided to the senders comment of the
E2B report
DATA ENTRY ACTIVITIES TAB
 The Activities tab
enables entry of
details of activities
related to processing
case information:
contact log, routing
comments, action
items, and case lock or
archive.
ACTIVITIES TAB/ CONTACT LOG
 Contact Log section allows
for entries to record
correspondence related to
the case, including letters
- To add a Contact Log
entry, click [Add] and
enter the ―Date‖, select
a ―Code‖, the
―Description― will
auto-populate based on
the code selected
- To remove unwanted
rows click [Delete]
ACTIVITIES TAB/ CONTACT LOG
Letter Correspondence
 Click [New Letter] to attach a
letter to the contact log. Select
Letter Template; click [OK].
 Open the letter; edit the letter,
save the modified letter locally.
 Click [Yes] to save the modified
letter and browse, and click
[OK] to attach the letter to the
case.
 An envelope icon will appear in
the Contact Log to enable
viewing the saved letter
 An action item for pending
follow-up is created in the
―Action Items‖ section
 Letter‘s can be sent via emailed
to the by clicking
- You will be prompted with
a message to clear the date
sent and marked read-
only. Click [Yes] to receive
the eMailing Letter dialog
box.
 ACTIVITIES TAB/ ACTION ITEMS
Action Items records the required tasks for the case and can be assigned to individuals or
groups
 To add an action item, enter the ―Date Opened‘, select a ―Code‖ (the description will
auto-populate based on the code selected)
 Click [Add] if additional action items are required
 Action Items should be closed when completed
ACTIVITIES TAB/ ROUTING A CASE

 The Case Routing dialog box opens

when routing a case forward or
returning to a previous workflow state
either from within the Routing
Comments section or utilizing the
[Routing] icons
 Routing Comments contain the
workflow routing history for the case
including comments and
Time/Date/User stamps
 Click [Route] to transition a case
forward to the next workflow state
 Click [Return] to transition a case back
to a previous workflow state
 The Date and User name are
automatically populated
 A brief description of the routing
activity may be entered as free text or
selected from a pre-defined list
 If the user has not finished workflow
activities, clicking [Cancel] will close
the dialog and routing will not occur.
 ACTIVITIES TAB/ CASE LOCK/ ARCHIVE
 Case Lock / Archive allows the user to lock, unlock, archive and un-archive a case
 From Activities tab, select ‗Unlocked‘, ‗Locked‘ or ‗Archived‘ from the ―Case Status‖
dropdown.
 To lock a case, select ―Lock‖ from the Case Status drop-down
 Locking a case prevents the core case data from being edited and enables auto-
scheduling.
- Administrative data like Contact Logs, Actions Items can be added or changed.
further data entry and enable.
 A user who is able to Lock a case is also able to Unlock a case.
 The Administrator can configure cases to auto-lock when routing to report
distribution
 Argus will auto-archive the case from the Distribution state so there is no need to
manually archive in that state. This can happen only when:
- there are no un-submitted reports in the case (i.e. no reports exist in the case
that are still in scheduled or generated state)
- there are no open action item
- there are no open contact log entries
 After routing a case to Distribution and locking the case, a final report can be
viewed
 DATA ENTRY ADDITIONAL INFO TAB
 The Additional Info module captures any Notes and Attachments and/or References related to the
case
 Source documents can be attached to each ―Notes and Attachment‖ line item by clicking the ―Attach
File‖ button
 Each attachment can be assigned a classification

 Reference numbers can be added in the References section

 A case can be linked to another case within the References section by clicking the ―Select‖ button and searching
for the linking case
UNBLINDING IN ARGUS
 BLINDING
Single Blinded Cases :
 the individual subjects do not know
whether they are so-called "test"
subjects or members of an
"experimental control" group.
 Single-blind experimental design is
used where the experimenters either
must know the full facts (for example,
when comparing sham to real surgery)
and so the experimenters cannot
themselves be blind, or where the
experimenters will not introduce
further bias and so the experimenters
need not be blind.
 However, there is a risk that subjects
are influenced by interaction with the
researchers — known as the
experimenter's bias wherein the
experimenter may consciously or
subconsciously influence the behavior
of the subject.
Double Blinded Cases :
 stringent way of conducting an experiment,
usually on human subjects, in an attempt to
eliminate subjective bias on the part of both
experimental subjects and the experimenters.
 In a double-blind experiment, neither the
individuals nor the researchers know who
belongs to the control group and the
experimental group. Only after all the data have
been recorded (and in some cases, analyzed) do
the researchers learn which individuals are
which.
 Performing an experiment in double-blind
fashion is a way to lessen the influence of the
prejudices and unintentional physical cues on
the results (the placebo effect, observer bias, and
experimenter's bias).
 Random assignment of the subject to the
experimental or control group is a critical part of
double-blind research design. The key that
identifies the subjects and which group they
belonged to is kept by a third party and not
given to the researchers until the study is over
 OVERVIEW
 Blinded Clinical Studies must be unblinded prior to submitting Serious cases to
Regulatory Authorities
 Company-sponsored studies determines whether the study is a blinded and if its
eligible to be unblinded
If a company-sponsored study is a single or a double-blinded study, restricted
-
users are unable to view blinded treatment information on the Product tab
(see fields below)
 The Medical Reviewer typically determines whether a case should be unblinded

 Once unblinded, the Unblinding Group receives single case unblinding

information by one of several methods: IVRS, Envelope, or directly from sponsor.
- The user unblinds and enters the patient treatment information in the case.

No Product Tab Blinded Fields No Product Tab Blinded Fields

1 Company Drug Code 10 Patient Route of Administration
2 Study Drug 11 Parent Route of Administration
3 Formulation 12 Package ID
4 Concentration 13 Pack Units
5 Outside Therapeutic Range 14 Batch / Lot #
6 Dose 15 Expiration Date
7 Dose Description 16 Total Dosage Units
8 Daily Dosage 17 Total Dose to Primary Event
9 Regimen Dosage
BLINDED CASES
 The case Blinding Status
and Study Type are
―Blinded‖ and ―Double
Blinded‖, respectively
 The Product Tab will
Blind fields to prevent
the user from viewing or
modifying the protected
information.
 In the Patient tab,
Patient Confidentiality is
also protected as well and
the case will be supplied
with the Pat ID and/or
Patient Randomization #
for that patient
 BREAKING BLIND OF SINGLE CASE

 The Blinded Status fields are

protected based on User
privileges while the study is not
yet unblinded.
 To unblind a single case, change
the value in the ―Blinding
Status‖ field to either Broken by
Investigator or Broken by
Sponsor as appropriate
 If user access is restricted from
unblinding a case, the user will
not be able to make changes to
Blinding Status
Blinding Status Description
Blinded Hides blinded treatment information from restricted users
Broken After Study Reveals blinded treatment information to allowed users and for regulatory reporting after the end of a study
Broken By Investigator Reveals blinded treatment information to allowed users and for regulatory reporting by request of Reporter
Broken By Sponsor Reveals blinded treatment information to allowed users and for regulatory reporting by request of Sponsor
Not Blinded Open label Study where all users are able to view treatment information
 END OF STUDY UNBLINDING

 At the end of a blinded study, Clinical Trial cases will need to be unblinded
 The End of Study utility can be used to unblind the cases associated with the study in bulk
instead of unblinding each case individually one by one
 Select Utilities > End of Study and the End of Study Unblinding dialog is provided to unblind
cases
 Select the study from the [End-of-Study Unblinding] dropdown field and a list of cases is
provided
 Select the [Drug Received] for each case
 Click [Select] to enter dosage information in the EOSU – Dosage Regimen dialog for each case as
needed
 Click [OK] to unblind all cases listed
WORK LIST
OVERVIEW
The Worklist plays an essential role in managing the case
activities that a user is responsible for including cases, letters,
contacts, reports and action items.
 The Worklist can be accessed by the menu bar to view
- New cases (not yet accepted)
- Open cases (already accepted)
- Transmission status of reports
- All bulk printed reports
- To-Do items such as action items, letters and contacts
 The Worklist displays relevant case data in the user‘s
Worklist based on the user group assignment (e.g. Case
number, seriousness, case type, product, event, workflow
status, and etc).
 Worklists are monitored to identify and prioritize work due
- Each user‟s worklist is tailored to the user‟s
responsibilities and contains only items that are relevant
to the user or the user‟s group(s).
 Once a case has been routed to the next workflow step, the
case will no longer appear in the user‘s Worklist after the
user clicks on the refresh button (unless the user is
responsible for the next workflow step as well).
NEW CASES
 Worklist > New contains
unassigned cases and case with
an owner but not accepted
- Workflow Managers able to
assigned cases to users and
the assigned user must need
to accept the case. The case
will then show on the users
Worklist > Open
- Contains cases in a
Workflow State belonging to
the user‘s group(s)
 Right-click on a row to view
actions that can be performed
(e.g. assign, accept case, adjust
priority, etc.)
 Filtering is available to quickly
search for specific items.
Available filters are:
- Filter by value: Case ID
number, Workflow state,
Product, Event PT, Event as
reported, Product Group
and Case Report Type
- Group Membership: select
your group to filter
OPEN CASES
 Worklist > Open contains
assigned and accepted cases by
the user or the user‘s group
- Cases should be accepted
by a user from Worklist
New and the user
becomes the owner.
 Right-click on a row to view
actions that can be performed
(e.g. assign, accept case, adjust
priority, etc.)
 Filtering is available to quickly
search for specific items.
Available filters are:
- Filter by value: Case ID
number, Workflow state,
Product, Event PT, Event
as reported, Product
Group and Case Report
Type
- Group Membership: select
your group to filter
CASE PRIORITIZATION
 Dynamic Workflow determines
 the time available for a given Workflow Step and
 the remaining of a Workflow until the case should be locked
Timing adjusts dynamically every time the case is routed to determine how
much time should be allocated for an on-time submission

Time left in current Time left in

workflow step overall workflow

Case Priority can be automatically or manually assigned

EXAMPLES

An example of a case at approximately

6pm on the day it was created, whose
first report is due in 11 days

An example of a case that is past the

first report due date

An example of a case that is overdue

in the current workflow state and is in
„Yellow‟ status for first report due
ACTION ITEMS
 Action Items affect case
processing

 Users can monitor the

action items on Worklist >
Action Items on a daily
basis and resolved

- Right-click and select

[Close Action Item] to
close an action item.

 Red flags indicate due /

overdue items. Blue Flags
are for future due items.

 Action Items created from

clicking [Generate Query]
icon can be displayed by
selecting [View Query
Action Items] and clicking
[Search]