ISP BestPractices LSMV Auto-Labeling-3.0

ISP Best Practices LSMV Auto-Labeling
Version: 3.0 | Effective Date: 19-Jan-2024
TP_1614, Template Version 2.2/13-Jul-2017 (Do not edit / Delete)

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June 2022
Table of Contents
Table of Contents
1 Auto-Labeling ............................................................................................................................. 1
1.1 Application Parameters Associated with Auto-Labeling.............................................................. 1
1.2 Workflow activity level Configuration .......................................................................................... 3
1.3 CPD Level Configurations for Auto-Labeling .............................................................................. 4
1.5 Auto-Labeling logic ................................................................................................................... 10
1.6 DSUR Labeling ......................................................................................................................... 13
1.7 Auto-labeling Scenarios ............................................................................................................ 15
2 Revision History ........................................................................................................................ 23
Document Classification: < Restricted > Page i

1 Auto-Labeling
Auto-labeling in LSMV is designed based on the industry standard practice (ISP) to meet the needs of
simple and complex labeling logics. The comprehensive set of fields needed for making a labeling
assessment as per the business process during processing of cases is included in the application
Company Product Dictionary (CPD) with a pre-defined logic to enable auto-labeling.
below is a high-level flow of the auto-labeling logic:
Country specific Datasheets can be configured for each product at the Preferred Product Description
(PPD) level in the CPD. The datasheets can be defined with only the labeling terms or can be defined
to include conditional rules and additional attributes to be considered for the labeling assessment.
Additional countries not associated with any datasheet can also be mapped to a PPD to create a
country specific labeling record for the product in the case.
Following sub-sections define the parameters and functionality associated with auto-labeling in LSMV.
1.1 Application Parameters Associated with Auto-Labeling
Parameter Name Options Functionality

Auto Product Labeling Checkbox This parameter drives the auto-labeling at the
application level.
If ‘Checked’, only then the system will look
into the other auto-labeling configurations
and perform auto-labeling as applicable.
Auto-Labeling Page 1
If ‘Unchecked’, no auto-labeling will be

performed for any product regardless of the
product level auto-labeling configurations.
Default Labeling Unlabeled Record OR This parameter drives whether a ‘Blank’
Blank Record labeling record should be created, or an
‘Unlabeled’ labeling record should be created
for the Selected countries (refer section 1.2) if
no Datasheet is configured for that particular
country for the product.
The system shall first look for the Default
Labeling for Country at the Selected Country
level for a product and if not configured then
shall look at the application parameter level.
Similarly, if no datasheet is maintained for
CORE or IB, a ‘Blank’ or an ‘Unlabeled’
labeling record will be created based on this
parameter.
Create Default Core Clinical Trial and/or This parameter enables to create default
Labeling Record Post-Market Cases Core labeling records for Clinical Trail and/or
Post-Market cases regardless of the Core
Datasheet being configured.
Note:
• Post-Market applies to all cases expect
Study Type = Clinical Trial
• Clinical Trial applies to all cases with
Create Default IB Clinical Trial Reports This parameter enables to create default IB
Labeling Record for and/or Post-market labeling records for Clinical Trail and/or
cases Spontaneous reports regardless of the IB
Datasheet being configured.
Note:
• Post-Market applies to all cases expect
• Clinical Trial applies to all cases with
Default Labeling for Unlabeled Record OR This parameter drives whether a ‘Blank’
Datasheet Blank Record OR No labeling record should be created, or an
Record ‘Unlabeled’ labeling record or No Record
should be created when the MedDRA term
(case) is not part of the configured Datasheet.
The Default Labeling for Datasheet is set as
'Unlabeled' by default if the term is not part of
the configured Datasheet.
The system shall first look for the Default
Labeling for Datasheet configuration at the
datasheet level for a product and if not
configured then shall look at the application
parameter level.
Refresh auto-assessed Checkbox This parameter determines when the system
labeling updates the labeling assessments associated
with a case:
• If enabled, labeling assessments will be

recalculated every time the case is saved,
regardless of whether there have been
changes to the case data.
• If disabled, labeling assessments will only
be updated in the following specific
situations:
a) A new company product or event is
added.
b) A new Country Datasheet is added.
c) There is a modification to an existing
event, specifically a change in the
MedDRA Preferred Term (PT) code.
d) There is a change to the Preferred
Product Description of an existing
product.
e) The seriousness of an event is updated
from non-serious to serious.
f) The onset date of an event is altered.
g) The form of administration under Drug-
>Therapy is changed.
h) The route of administration under Drug-
>Therapy is modified.
i) There is a MedDRA coding change for
an indication, specifically a change in
the PT code.
j) The strength or strength unit of the
product is changed.
k) The Serious Criteria at the event level
is updated, but only for 'Death' and 'Life
Threatening' criteria.
l) There is a change in the Study section,
either the Sponsor Study Number or
the Study Type.
Please note that changes to the MedDRA PT
code resulting from a MedDRA upgrade do
not trigger a recalculation of the labeling
assessment.
Note: All other country labeling records (other than IB and Core) as applicable to the product needs to
be configured at each PPD level either as a Selected Country (no Datasheet associated) or with the
corresponding Country Datasheet associated to the PPD and will be applicable to all case types.
1.2 Workflow activity level Configuration

Disable auto labeling Checkbox This parameter controls the auto-labeling
functionality in a specific workflow activity.
If configured for a workflow activity, auto-

labeling is turned off in that activity and the
labeling data will not be updated regardless
of the labeling configuration at Application
Parameter or the CPD level. By default, this
parameter is configured in activities beyond
Case Approval activity.
If not configured, the system will take into

account other auto-labeling settings, such as
those specified at the application parameter
level or product level, and will carry out auto-
labeling as configured.
1.3 CPD Level Configurations for Auto-Labeling

I Enable Auto Yes or No This parameter drives the auto-labeling at the product
Labeling? level.
If ‘Yes’ is selected, only then the system will look into the
Selected Countries/Configured Datasheet(s) and perform
auto-labeling as applicable.
If ‘No’ is selected, no auto-labeling will be performed for
the product regardless of the application level auto-
labeling configurations. Labeling for this PPD needs to be
entered manually.
Selected Country Codelist If a country is selected and no corresponding datasheet is

Countries created for the country for the product, a Blank or
Unlabeled labeling record will be created for the Country
based on the Default Labeling For Country and
Conditional Rule configuration for each selected country.
If Default Labeling for Country is not configured for a

selected country, the labeling shall be based on the
Default Labeling configuration in application parameter.
Default Labeling Unlabeled This parameter provides ability to configure default

For Country Record OR Blank labeling for selected countries at Product (CPD) level in
Record addition to the application parameter level so that user
can determine in case level for the events which are not
part of any datasheet as to be updated as "Unlabeled" or
"Blank Record" for the selected country.
If Default Labelling For Country is configured as

"Unlabelled" for a selected country record at Product
(CPD) level when the selected country was not part of the
datasheet countries then system shall update the
labelling for the event as "Unlabelled" in the case as per
the parameter for selected country record.
If Default Labelling For Country is configured as "Blank

Record" for a selected country record at Product (CPD)
level when the selected country was not part of the
datasheet countries then system shall update the
labelling for the event with "Blank" value in the case as
per the parameter for selected country record.
If Default Labelling For Country is not configured as either
"Unlabelled/Blank Record" for a selected country record
at Product (CPD) level when the selected country was not
part of the datasheet countries then system shall update
the labelling for the event as per the configuration in
application parameter for Default Labelling.
Conditional Rule Look up This parameter provides ability to configure the

conditional rules in the selected countries to create a
labelling record in the case level when case satisfied with
all the conditions as per the rule configured so that only
the required selected countries configured for a product
which needs the auto labelling will be triggered in the
case.
If conditional rule is configured for a selected country

record for a product in CPD, when the user updates the
respective product in the case, then the system shall
create a labelling record for that selected country in the
case when the case meets the conditional rule.
If conditional rule is configured for a selected country
record for a product in CPD, when the user updates the
respective product in the case, then the system shall not
create a labelling record for that selected country in the
case when the case does not meets the conditional rule.
If the user has not configured any conditional rule to a
selected country record for a product in CPD when the
user updates the respective product in the case
management then the system shall create a labelling
record in the case for the respective selected country.
1.4 Datasheet Level Configurations for Auto-Labeling
Multiple Datasheets can be configured for a PPD either by clicking on ‘Add’ to add a new Datasheet
or by clicking ‘Copy’ to copy an existing Datasheet associated with the PPD to create a new
Datasheet under the same PPD.

Datasheet Name Free Text This fields captures the name of the datasheet.
Country Country Codelist This field captures the country associated with the
datasheet for which the labeling record should be
created.
Active Checkbox This field indicates whether the Datasheet is Active or
Inactive. Only Active Datasheet are considered for Auto-
labeling.
Labeling Free Text This field captures the document number for the
Document datasheet used for labeling. The document number
Number including should include the versioning of the datasheet. Ex: IB
version version used for labeling at the time of event
Effective Labeling Calendar This field captures the effective date from when the
Date version of the datasheet should be considered.
Version of the labeling document will be considered
based on the Effective Labeling Date and Event Onset
Date/LRD as applicable (Refer section 1.4 for logic).
If the event occurred post the effective date of the
datasheet, the corresponding datasheet will be
considered for labeling.
Default Labeling Unlabeled This to define the parameter for "Default labelling for
for Datasheet Record OR Blank Datasheet" at Product (CPD) level in addition to the
Record OR No application parameter level so that user can determine in
Record a case for the events which are not part of the
datasheet/attribute not matching to the datasheet as to be
updated as "Unlabeled" or "Blank Record" or “No
Record”.
By default no value shall be selected for Default labelling
for Datasheet in the datasheet.
Given the Parameter for Default Labelling for Datasheet

is configured as "Unlabeled" in Datasheet at Product
(CPD) level when the user updates an event in the case
which is not part of the datasheet/attribute not matching

as per the datasheet then system shall update the
labelling for the event as "Unlabeled" in the case.
is configured as "Blank Record" in Datasheet at Product
as per the datasheet then system shall update the
labelling for the event with "Blank" value in the case.
is configured as "No Record" in Datasheet at Product
as per the datasheet then system shall not create any
record for the event.
is not configured as either "Unlabeled/Blank Record/No
Record" in Datasheet at Product (CPD) level when the
user updates an event in the case which is not part of the
datasheet/attribute not matching as per the
datasheet then system shall update the labelling for the
event as per the configuration in application parameter for
Default labelling.
Conditional Rule Look-up This parameter shall allow the user to configure the
conditional rules in the Datasheet level to create a
Datasheet in the case, when the case is satisfied with all
the conditions as per the rule configured so that only the
required datasheets configured for a product which needs
the auto labelling will be triggered in the case.
Given a conditional rule is configured in the Datasheet

level for a product in CPD when the user updates the
respective product in the case then the system shall
apply that respective datasheet by creating a labeling
record in the case when the defined conditions are met.
Given a conditional rule is configured in the Datasheet

level for a product in CPD when the user updates the
respective product in the case then the system shall not
apply that respective datasheet when the defined
conditions are not met.
Given the user has not configured any conditional rule for
a datasheet in CPD when the user updates the respective
product in the case then the system shall consider that
datasheet for labelling and a labelling record shall be
created for that product-event based on the Additional
Attributes and Default Labeling for Datasheet
configuration.
Additional Attributes
Indication(s) Look-up This field allows associating an additional attribute of
indication to auto-labeling.
When configured, the application looks for the indication
in addition to the Product-Event combination for auto-
labeling.
Attached Indication(s) allow to select the indications
associated with the product in the library.
Add Indication(s) allow to add additional indications not
associated with the product in the library.
Form of Admin Form of Admin This field allows associating an additional attribute of
codelist Form of Admin to auto-labeling.
When configured, the application looks for the Form of
Admin in addition to the Product-Event combination for
auto-labeling.
Route of Admin Route of Admin This field allows associating an additional attribute of
codelist Route of Admin to auto-labeling.
When configured, the application looks for the Route of
Admin in addition to the Product-Event combination for
auto-labeling.
Strength and the Free Text Field This field allows associating an additional attribute of
Strength Unit and Strength Strength and Strength Unit to auto-labeling.
codelist When configured, the application looks for the Strength
and Strength Unit in addition to the Product-Event
combination for auto-labeling.
Protocol Look-up This field allows associating an additional attribute of
Protocol to auto-labeling. The system allows maintaining
multiple protocols in this section.
When configured, the application looks for the Protocol
information in addition to the Product-Event combination
for auto-labeling.
Labeling Term: Note: A PT/LLT/SMQ or CMQ should be defined for the labeling term under a
datasheet.
PT Term and Look-up This field allows associating a PT term to the Datasheet.
Code When the Product-Event (PT) combination in the case
matches the labeling term configured in the datasheet,
auto-labeling is applied in consideration with the other
attributes (if any).
LLT Term and Look-up This field allows associating a LLT term to the Datasheet.
Code When the Product-Event (LLT) combination in the case
matches the labeling term configured in the datasheet,
auto-labeling is applied in consideration with the other
attributes (if any).
SMQ/CMQ Term Look-up This field allows associating a SMQ/CMQ to the
and Code Datasheet.
When the Product-Event (SMQ/CMQ) combination in the
case matches the labeling term configured in the
datasheet, auto-labeling is applied in consideration with
the other attributes (if any).
Labeled? Yes or No This field identifies the configured labeling term as either
labeled (Yes) or Unlabeled (No).
Conditional Checkbox If Conditional labeling? is checked, then a BLANK
Labeling? labeling record corresponding to the Country will be
created within the Case and the Reason will be updated
with the Conditional Labeling Comment. User will have to
review the Comment under the Reason and select the
Labeling accordingly.
Conditional Free Text This field allows to capture any conditional labeling
Labeling comments associated with the labeling term.
Comment
Include Fatal Checkbox
Event? System shall include the seriousness criteria with below
options and shall have OR condition between the
Life Threatening? seriousness criteria.
Other Include Fatal Event?

Seriousness? Life Threatening?
Other seriousness (Caused/Prolonged Hospitalization,
Disability/Permanent Damage? Congenital
Anomaly/Birth Defect? and Other Medically Important

Condition)
Include Fatal Event? This field allows to consider a fatal

event as labeled when checked.
- unticked = the term is only labeled for non-fatal

outcomes, provided labeled is selected as Yes
- ticked = the term is labeled for both fatal & non-fatal
outcome
By default, this will be unchecked.
Life Threatening and Other Seriousness: This field allows

to consider a Life Threatening and non-Fatal serious
event as labeled when checked.
- unticked = the term is only unlabeled for Life

Threatening and non-Fatal serious event.
- ticked = the term is labeled for both life threatening

and non-Fatal serious event
By default, this will be ticked.
Given the user configured the datasheet in CPD with

Other Seriousness Ticked then system shall auto label
the term with seriousness criteria selected as Yes (except
for Death and LT) as labelled if Labelled is selected as
Yes and shall auto label the term as unlabelled if Labelled
is selected as No
Given the user did not configure the datasheet in CPD
with any of the seriousness criteria, when seriousness in
the case for an event is Non serious, then system shall
auto label the term as labelled if Labelled is selected as
Yes and shall auto label the term as unlabelled if Labelled
is selected as No
Given the user configured the datasheet in CPD for an
event, when few seriousness criteria were checked, and
few were not checked then system shall take the
precedence in the below order.
Death>Life Threatening>Other seriousness
1.5 Auto-Labeling logic
- System first checks if a condition rule is configured to a datasheet

o If configured, the system checks if the case data is matching the condition rule set for the
datasheet
o If the case data is not matching the condition rule, the DS is not considered for labeling
o If condition rule is not configured, then the system moves to next step to check for
attributes.
- System checks, if case criteria match to a data sheet with same PPD/Attribute(s) combination
in CPD
o One match found: apply auto-labeling based on this data sheet
 The system will check if the event reported in the case is available in the
datasheet,
 If available, the system will apply auto-labeling based on this data sheet by
creating a labelling record in the case with the country from the datasheet and
label the event labelled or Unlabeled based on the configured value
 If not available, the system will mark the labeling based on Default labelling for
datasheet configuration at DS level.
 If a default labeling for datasheet is not configured, the system will check the
Default labelling for datasheet configuration at the application parameter level
o no match found: check if a data sheet is available in CPD for this PPD/Country
combination with all attributes = blank
 if yes: apply auto-labeling based on this data sheet (PPD/Country/blank
parameters)
 if no: mark the labeling as per Default labelling for datasheet configuration
As a Best Practice, it is recommended to have at least one datasheet without any
attributes.
o If partial match found in a datasheet, follow logic as per ‘no match found’
o If more than one data sheet matches, check if labeling is labeled in all the matching
data sheets
 if yes (labeling is labeled in all the matching data sheets), set to labeled
 if no (labeling is different across the matching datasheets), set to unlabeled
Note: The application shall apply the following sequence when verifying the attributes against
the case data: Protocol>Indication>Form of Admin>Route of Admin>Fatal
- System automatically adds a blank labeling record for each product-event combination
captured in the case (where company product flag is set 'Yes' for the corresponding product)
when there is no data sheet/selected countries configured for the product but ‘Enable auto-
labeling’ is selected at the Product level in the CPD. If a labeling record exists based on the
datasheet, selected country or application parameter configuration, then a Blank labeling
record for the product-event combination will not be created.
- Additionally, Blank Labeling records can be manually created by clicking the “Add” or “Add All
Events” option in the labeling screen for that product. On Clicking “Add”, the application
creates a Blank Labeling record and the user needs to select the Event and enter the Country
and the Labeling information. On Clicking “Add All Events”, a Blank Labeling record will be
created for all the events under the specific product provided no labeling record is available
for the event-product combination.
Auto-(re) calculation of labelling happens on each case save provided the manual check box
is unchecked for the labelling record.
During the auto-(re) calculation, the application considers the changes to both case data as
well as datasheet/selected counties configuration to update the labeling information.
Note:
o When data sheet is removed or made inactive, the previously populated labeling
records will not be recalculated.
o Data sheet level configurations shall take precedence over the selected country when
recalculating the labeling. For example, if a Selected Country was configured
previously and a Blank or Unlabeled labeling record was created for the Product-
event-country combination based on the application parameter and now if a data

sheet is created for the same country, then the application shall recalculate the
Labeling for the product-event-country combination based on the datasheet instead of
considering the Selected Country-Application parameter configuration.
Any labeling data populated based on application parameter will not be updated with changes
to the application parameter or recalculated by unchecking the manual checkbox.
- Auto-labeling shall consider the datasheet version corresponding to the Effective Labeling
Date based on the below logic.
o The Event Onset Date is same as or after the Effective Labeling Date
o If partial Event Onset Date is provided (MMM-YYYY/--YYYY), the imprecise date
logic (first day of the month or the first day of the year respectively) should be applied
to compare the Event Onset Date against the Effective Labeling Date
o If Event Onset Date is Blank, Latest Received Date (LRD) shall be compared against
the Effective Labeling Date to identify the Datasheet version to be applied.
Effective Labeling
Date (V 1.0) 15-Jan-19 Logic
No auto labeling will be performed as event occurred
Event onset date 15-Oct-18 prior to the Effective Labeling Date
Event onset date 15-Oct-19 Auto labeling will be performed as per V 1.0
Auto labeling will be performed as per V 1.0
Event onset date Oct-2019 considering event onset date as 01-Oct-2019
No auto labeling will be performed considering event
onset date as 01-Jan-2019, which is prior to Effective
Event onset date 2019 Labeling Date.
Event onset date blank Auto labeling will be performed based on the LRD
- Labeling Functionality in Compare and Reconcile:

o The Auto-labeling data is refreshed or retained on Compare and Reconcile based on
the Application parameter configuration and case data changes in the merged follow-
up.
o Manual labeling is retained from parent to follow-up for existing Product-Event-
Country combination. If for a Product-Event-Country combination the manual labeling
is populated in both Parent and Follow-up case, then the latest information is
retained.
o In a scenario where the parent case is unblinded and the follow-up receipt is
processed as blinded, on compare and reconcile, the labeling records from the
unblinded parent case will be retained along with the unblinded status of the case.
1.6 DSUR Labeling
- System shall allow to bulk update the DSUR labeling record for a series of case corresponding to
the DSUR period, so that the appropriate data can be included in the DSUR report with minimal
user intervention to update the DSUR labeling within each case identified for the DSUR.
Note: Datasheet of DSUR and Country of DSUR shall only be applicable for DSUR labeling.
- User can create DSUR Case Series from QBE and the system shall provide the option to
perform DSUR labeling from Case Series.
- When the user clicks on the DSUR labeling option in case series, the system shall provide the
user an option to select the appropriate DSUR labeling data sheet (regardless of the
Active/Inactive status) corresponding to the product selected using the product look-up. DSUR
Labeling Datasheet should be configured in the CPD for the selected product.
- The user shall select the DSUR datasheet to be applied and execute the DSUR labeling, then the
system shall create a DSUR labeling record for all the cases within the Case Series for the
selected Product as per the selected Datasheet. Note: OOB Auto-Labeling logic shall be applied.
- For a case if DSUR labeling record already exists, then the system shall update the existing
DSUR labeling record based on the selected DSUR datasheet on executing the DSUR labeling.
- When the DSUR labeling has failed or partially updated (ex: conditional labeling) after execution,
the system shall allow the privileged user to manually update the labeling information within the
case from the Case Series.
- Note: Manual update shall be allowed for successfully labeled cases as well.
- When a case is being processed by the user workflow, then the system shall not auto-label the
product-event combination based on DSUR datasheet even though the criteria is met and the
Datasheet is Active.
- The system shall display the following status against each case included in the series, when the
user reviews the individual cases within the Case Series,
o Success: Auto-labeling updated as per the Latest/Selected DSUR Datasheet
o Failed: Auto-labeling was not updated due to no match (Ex: Product not available) or case
version is unapproved/open in workflow
o Partial: Conditional Auto-labeling record updated. Manual intervention required to update the
labeling as per condition.
1.7 Auto-labeling Scenarios
Parameter Name Options Configuration

Enable Auto Labeling? Yes or No Yes
Default Labeling Unlabeled Record OR Blank Unlabeled
Record
Create Default Core Labeling Clinical Trial Reports and/or Post- Post-Market
Record Market Reports
Create Default IB Labeling Clinical Trial Reports and/or Post- Clinical Trial
Record Market Reports
Default Labeling For Datasheet Unlabeled Record OR Blank Unlabeled
Record OR No Record
1.7.1 Scenario 1: Attributes configured, Conditional Rule Configured for DS, and Default
Labeling for DS: Not Configured
Product 1 Auto- Labeling Yes

Selected Countries
USA
GERMANY
Data Sheet 1 Country Labeled? Data Sheet 2 Country Labeled?

Headache CORE Yes Headache USA Yes
Confusion CORE Yes Rash USA Yes
Case 1 Case 2
Report Type Spontaneous Report Type Study
Suspect/Drug Suspect/Drug
Interaction/DNA Product 1 Interaction/DNA Product 1
Event (PT) Red Eye Event (PT) Red Eye
Labeling Country Labeling Labeling Country Labeling
CORE Unlabeled IB Unlabeled
USA Unlabeled USA Unlabeled
GERMANY Unlabeled GERMANY Unlabeled
Case 3
Report Type Spontaneous
Suspect/Drug
Interaction/DNA Product 1
Event (PT) 1 Red Eye Event (PT) 2 Rash
Labeling Country Labeling Labeling Country Labelled?
CORE Unlabeled CORE Unlabeled
USA Unlabeled USA Labeled
Event (PT) 3 Confusion Event (PT) 4 Headache

Labeling Country Labelled? Labeling Country Labelled?
CORE Labeled CORE Labeled
USA Unlabeled USA Labeled
1.7.2 Scenario 2: Labeling for fatal events

Selected Countries
USA
GERMANY
Data Sheet 1 Country Labeled? Fatal?

Heart Attack CORE Yes Yes
Shock CORE Yes No
Case 1 Case 2
Report Type Spontaneous Report Type Spontaneous
Product 1 Product 1
Interaction/DNA Interaction/DNA
Event (PT) Heart Attack Event (PT) Shock
Outcome Fatal Outcome Fatal
CORE Labeled CORE Unlabeled
Case 3
Suspect/Drug
Product 1
Interaction/DNA
Event (PT) 1 Heart Attack Event (PT) 2 Shock
Outcome Recovered Outcome Recovered
CORE Labeled CORE Labeled
1.7.3 Scenario 3: Labeling based on different attributes (Form of Admin, Route of Admin and
Indication):

Selected Countries
USA
GERMANY
Datasheet
Datasheet 3>Core>Form of Datasheet
Datasheet
2>Core>Route Admin (Solution 4>Core>Indication (Lung
1>Core>Blank
of Admin (Oral) for injection Cancer)
/infusion)
Abdominal pain Yes - - -
Weight loss - - Yes
Anaphylactic
- - Yes -
reaction
Dry mouth - Yes - -

Headache Yes Yes - -
Fever - Yes Yes -
Case 1 Case 2
Product 1 Product 1
Event (PT) Anaphylactic reaction Event (PT) Anaphylactic reaction

Solution for
Form of Admin Capsule Form of Admin
injection/infusion
Labeling (correct, DS3
Labeling Country Labeling (correct, DS1 applied) Labeling Country
applied)
CORE Unlabeled CORE Labeled
Case 3 Case 4
Product 1 Product 1
Event (PT) 1 Dry Mouth Event (PT) 2 Rash
Route of Admin Oral Route of Admin Intravenous Infusion
Labeling (correct, DS 1
Labeling Country Labeling(Correct, DS 2 applied) Labeling Country
applied)
Case 5 Case 6
Product 1 Product 1
Event (PT) 1 Weight Loss Event (PT) 1 Weight Loss
Indication Hypertension Indication Lung Cancer
Labeling (correct, DS 4
Labeling Country Labeling (correct, DS 1 applied) Labeling Country
applied)
CORE Unlabeled CORE Labeled
Case 7 Case 8
Product 1 Product 1
Event (PT) 1 Headache Event (PT) 1 Headache
Indication Hypertension Indication Lung Cancer
Route Intravenous infusion Route Not reported
Labeling Country Labeling (DS 1 applied) Labeling Country Labeling (DS 4 applied)
Case 9 Case 10
Product 1 Product 1
Event (PT) 1 Weight Loss Event (PT) 1 Headache
Indication Hypertension Indication Hypertension
Solution for
Route Oral Route
infusion/injection
Labeling Country Labeling (DS 2 applied) Labeling Country Labeling (DS 3 applied)
CORE Unlabeled CORE Unlabeled
Case 11
Suspect/Drug
Product 1
Interaction/DNA
Event (PT) 1 Headache
Indication Hypertension
Route Oral
Labeling Country Labeling (DS 2 applied)
CORE Labeled
USA Unlabeled
GERMANY Unlabeled
1.7.4 Scenario 4: Labeling based on Protocol:

Selected Countries
USA
GERMANY
Datasheet Datasheet
Datasheet
2>IB>Protocol 3>IB>Protocol
1>IB>Blank
(Paediatric) (Adult)
Abdominal pain Yes - -
Nausea - Yes -
Rash - - Yes
Urticaria - - Yes
Headache Yes Yes
Case 1 Case 2
Report Type Study Report Type Study
Product 1 Product 1
Event (PT) Abdominal Pain Event (PT) Nausea

Protocol NA Protocol Paediatric
Labeling (correct, DS
Labeling Country Labeling (correct, DS1 applied) Labeling Country
2 applied)
IB Labeled IB Labeled
Case 3 Case 4
Product 1 Product 1
Event (PT) Rash Event (PT) Urticaria
Protocol Pediatric Protocol Adult
Labeling (correct DS 3
Labeling Country Labeling (correct DS 2 applied) Labeling Country
applied)
IB Unlabeled IB Labeled
Case 5 Case 6
Product 1 Product 1
Event (PT) Headache Event (PT) Headache

Protocol NA Protocol Adult
Labeling (DS 3
Labeling Country Labeling (DS1 applied) Labeling Country
applied)
IB Labeled IB Labeled
Case 7
Report Type Study
Suspect/Drug
Product 1
Interaction/DNA
Event (PT) Headache

Protocol Pediatric
Labeling Country Labeling (DS2 applied)
IB Unlabeled
USA Unlabeled
GERMANY Unlabeled
Scenario 5: Attributes configured, Conditional Rule Configured for DS, and Default Labeling for DS:
Configured
2 Revision History
Document Revision History

Version Section Description of Change Justification of
Number Change
0.1 All New document. NA
0.2 1.4 Updated the logic based on Effective Labeling Decision from
EA Workshop
0.3 1 and 1.4 Updated the flow-chart as per the sequence of Customer
verification performed by the application for auto- feedback
labeling
Updated the auto-labeling logic for sequence of
verification performed by the application for auto-
labeling and the logic when multiple datasheet
matches are found.
Added DSUR
0.4 1.1, 1.3, Updated the application details with Default Customer
1.4 and 1.5 Labeling for Datasheet feedback
Updated Additional Attributes with Strength
details
Updated auto-labeling logic
Added details on DSUR Labeling
1.0 1.4 Updated scenarios corresponding to Auto-labeling Customer
recalculation feedback
2.0 1.3 Updated the protocol section with implemented New
changes in 10.4.4 implementation
3.0 1.1, 1.2 and Updated the following in line with 2023.2.0.0 New
1.5 implementation. implementation
• Added details of new configuration “Refresh
auto assessed labeling.”
• Added new section of “1.2: Workflow activity
level Configuration: Disable auto labeling “
• Added: Labeling Functionality in Compare
and Reconcile
REVISION HISTORY Page 23

ISP BestPractices LSMV Auto-Labeling-3.0

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ISP Best Practices LSMV Auto-Labeling

Version: 3.0 | Effective Date: 19-Jan-2024

TP_1614, Template Version 2.2/13-Jul-2017 (Do not edit / Delete)

Document Classification: < Restricted > Page i

1.1 Application Parameters Associated with Auto-Labeling

Parameter Name Options Functionality

If ‘Unchecked’, no auto-labeling will be

• If enabled, labeling assessments will be

1.2 Workflow activity level Configuration

Parameter Name Options Functionality

If configured for a workflow activity, auto-

If not configured, the system will take into

1.3 CPD Level Configurations for Auto-Labeling

Parameter Name Options Functionality

Selected Country Codelist If a country is selected and no corresponding datasheet is

If Default Labeling for Country is not configured for a

Default Labeling Unlabeled This parameter provides ability to configure default

If Default Labelling For Country is configured as

If Default Labelling For Country is configured as "Blank

Conditional Rule Look up This parameter provides ability to configure the

If conditional rule is configured for a selected country

1.4 Datasheet Level Configurations for Auto-Labeling

Parameter Name Options Functionality

Given the Parameter for Default Labelling for Datasheet

which is not part of the datasheet/attribute not matching

Given a conditional rule is configured in the Datasheet

Given a conditional rule is configured in the Datasheet

Other Include Fatal Event?

Anomaly/Birth Defect? and Other Medically Important

Include Fatal Event? This field allows to consider a fatal

- unticked = the term is only labeled for non-fatal

Life Threatening and Other Seriousness: This field allows

- unticked = the term is only unlabeled for Life

- ticked = the term is labeled for both life threatening

By default, this will be ticked.

Given the user configured the datasheet in CPD with

1.5 Auto-Labeling logic

- System first checks if a condition rule is configured to a datasheet

event-country combination based on the application parameter and now if a data

- Labeling Functionality in Compare and Reconcile:

1.6 DSUR Labeling

1.7 Auto-labeling Scenarios

Parameter Name Options Configuration

Product 1 Auto- Labeling Yes

Data Sheet 1 Country Labeled? Data Sheet 2 Country Labeled?

Event (PT) 3 Confusion Event (PT) 4 Headache

1.7.2 Scenario 2: Labeling for fatal events

Product 1 Auto- Labeling Yes

Data Sheet 1 Country Labeled? Fatal?

Product 1 Auto- Labeling Yes

Dry mouth - Yes - -

Report Type Spontaneous Report Type Spontaneous

Event (PT) Anaphylactic reaction Event (PT) Anaphylactic reaction

GERMANY Unlabeled GERMANY Unlabeled

USA Unlabeled USA Unlabeled

GERMANY Unlabeled GERMANY Unlabeled

GERMANY Unlabeled GERMANY Unlabeled

GERMANY Unlabeled GERMANY Unlabeled

GERMANY Unlabeled GERMANY Unlabeled

1.7.4 Scenario 4: Labeling based on Protocol:

Product 1 Auto- Labeling Yes

Event (PT) Abdominal Pain Event (PT) Nausea

GERMANY Unlabeled GERMANY Unlabeled

Event (PT) Headache Event (PT) Headache