eLabels Initiative - eLabels Toolkit v2.0

eLabels Toolkit v2.0
11 December, 2017
Disclaimer: The eLabels Design and Delivery Toolkit is not tailored to any particular factual situation and is provided “as is” without warranty of any kind, express or implied,
including but not limited to fitness for a particular purpose. TransCelerate, accepts no responsibility for any loss of any kind including loss of revenue, business, anticipated savings
or profits, loss of goodwill or data or for any indirect consequential loss whatsoever to any person using this Toolkit or acting or refraining from action as a result of the information
contained in this Toolkit. TransCelerate provides this Toolkit for informational and illustrative purposes only. Each company must make its own decisions and is responsible for its
own choices and actions regarding how it designs and implements any eLabels solution. By using and exercising your license to these materials, you manifest your
acknowledgment and agreement that TransCelerate bears no responsibility or liability for any loss, harm, or damage arising from your use of this Toolkit.

Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 2
TABLE OF CONTENTS
1. Introduction
2. Key eLabels Concepts
3. Conventional Clinical Labeling
4. eLabels Concepts
4a. eLabels Overview
4b. Universal Printed Label
4c. Documenting eLabels Processes and Illustrative Cycle Time Improvement
4d. eLabels Risk Assessment
5. eLabels Health Authority Landscape
6. eLabels from the Site and Patient Perspective
6a. Overview
6b. Insights from Investigative Sites
6c. Insights from Patients
7. eLabels Technology Approach
6a. Technology Landscape Assessment
6b. eLabels Technical Architecture
6c. eLabels Use Cases and Example of an eLabel
8. Appendices

Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
Preamble – Why eLabels?
The world around us continues to evolve and become more technologically advanced. Technology improves our lives in many ways and may fit
in a number of categories such as safety, efficiency, access to information, medical advancements, and providing entertainment to name a few.
The purpose of the eLabels initiative is to advance label technology based upon safety and efficiency advantages.
An electronic label, or eLabel, is the provision of a complete investigational medicinal product (IMP) label on an electronic device while still
utilizing a printed label on the physical packaging. There are no regulatory requirements that preclude repeating the printed label information in
an electronic format. However, the long term goal is to use the elabel in conjunction with a simplified paper label that will contain minimal,
language agnostic, information and/or symbols that are non-translatable for identification, dispensing, and safety purposes, “Universal label”. This
Universal label concept is being discussed with global Health Authorities and acceptance of the concept is dependent on the regulations of each
country, which vary.
Relative to conventional booklet labels, eLabels:
• Are more patient centric and could be combined with instructional videos, eDiaries, patient communications, smart packaging technology, etc.
• Do not have a maximum length or number of panels
• Are not printed with a small font on a paper label, but could be enlarged
• Would require less time to develop, modify, and apply which will lead to faster delivery of clinical trial material
• Do not need to be removed prior to use of a device (e.g., syringe)
• Can be customized “just in time” for a specific study and/or site with the remaining paper label containing only general information so that the product can be used
in multiple clinical trials and/or countries within a development program
• Can be developed in parallel to packaging rather than sequentially
• Can be updated mid-trial without needing to “tamper” with the physical packaging to replace/modify a paper label which could lead to product mix-ups, time out
of storage conditions, and causing the packaging to appear opened
• Leverage technology to present the label information to a patient in his/her own language immediately instead of searching through a multi-page booklet label
A listing of pain points and benefits across stakeholders is available on Slide 5.
TransCelerate’s Toolkit is intended to facilitate a company’s ability to implement eLabels. TransCelerate is also working with Health Authorities to
evolve regulatory requirements in a manner that would allow broad eLabels usage in clinical trials.
1 Introduction
4

▪ Low usefulness of booklet labels: Few are opened,
limited space and small fonts
▪ Booklet labels may impede functional use of a syringe
or auto-injector
▪ Information on label is there to meet regulatory
requirements, but may not include helpful information
for the patient (eg, administration information)
▪ Increases efficiency in clinical development allowing for patients to
receive medicines faster
▪ Increases patient safety
▪ Enhanced utility of clinical labels and potential for better
compliance, e.g.:
▪ Limited to no utility for sites except for the trial alias
and kit number to aid in dispensing
▪ Limited or no space to write on the label
▪ Rapid access to up-to-date information
▪ Greater efficiencies in Labeling approaches
▪ Lays a future foundation for engaging with the patient about their
medication
▪ New labeling technology has surpassed regulations
▪ Need to advance public health by accelerating
innovation
▪ Decreases potential for deviations during extension re-labeling: e.g.:
sterility, tamper evident seal, product mix-up, time out of
environment
▪ Ensures latest information available for patients
▪ Ties into broader digital and innovation strategies
▪ Paper labels are static, making updates lengthy and
costly
▪ Multiple label groupings are needed to support global
trials
▪ Long creation and approval times (multiple months)
delay getting medicine to patients
▪ Increases operational efficiencies in creation of label
▪ Allows for additional pooling strategies which decreases waste
▪ Decreases reaction time to study changes
▪ Increases options for significant value-adds such as adherence
programs, patient analytics, patient education
Patients
Sites
Sponsors
Pain Points of Current Labeling eLabels Benefits
Health
Authorities
➢ Dosing videos
➢ Supplements to communication
➢ Improved usability (e.g. larger font size)
eLabels Address Common Pain Points and Benefits
Stakeholders Across the Industry
1 Introduction
Pain points and benefits may vary by sponsor
5

Toolkit Objectives and Guiding Principles
1 Introduction
The toolkit can be used in a highly flexible manner, as reflected in the guiding principles below.
• Each company is free to decide for itself and must decide for itself whether and to what extent to adopt eLabels. This
toolkit is merely intended to help those who decide to implement eLabels to do so.
• Each company must make its own decision where to use any or all individual Design and Delivery toolkit components.
• Each company is free to (re)design one or multiple components to meet its needs.
• The implementation toolkit is a high level roadmap and is meant to provide general guidance, not a step-by-step set of
instructions.
• Implementation components are generic and may need to be tailored to a company prior to use.
• Detailed steps for each implementation component are merely potential options to be further defined by each company.
• The order of the modules is a suggested order, but this is not fixed.
The Design and Delivery toolkit is:
• High-level roadmap of activities that facilitate implementation of eLabels
• Potential sequence of activities and resource considerations
• A collection of feedback from external stakeholders (Health Authorities,
Patients and Sites)
.. but is not:
• A standard
• A detailed work plan
• Activities that must be followed
including company-specific
documentation
6

Considerations for Planning and Implementing eLabels
Step Description Purpose
Review the toolkit instructions and use Understand toolkit’s flexibility
Identify company’s eLabels capabilities Understand how applicable toolkit
modules can facilitate company’s
implementation
Assess feasibility of eLabeling for your company Use as input to define scope of
implementation
Identify applicable modules and create
implementation plan
Understand work efforts and
resource needs
Execute against plan. Feel free to use modules,
templates and examples in this toolkit and modify,
as needed.
Complete implementation steps
1
2
3
4
5
1 Introduction
7

Introduction – eLabels Modular Design is the Foundation to
Enhance Patient Benefits and Enable Future Innovation
The TransCelerate eLabels initiative has identified three themes for a Modular Design
approach to eLabels for clinical studies.
Enhance
Foundation
Add-on
2 Key eLabels Concepts
▪ Provide enhanced access to information about the Investigational
product, preparation, dispensing, storage and use.
▪ In the future, links to multiple media types and languages could be
added to enhance further accessibility.
▪ Adherence reminders
▪ Provide ability for real-time updates to label content.
▪ Enable innovation through added functionality to improve patient and site
experience and enhance data integrity. Potential examples:
▪ Features to simplify Investigator sites processes such as receipt, inventory
management, and accountability
▪ Sensors (e.g., temperature, humidity, compliance) to record real-time data
▪ Provide regulatory-compliant label content via a user-friendly,
electronic equivalent with a simplified paper label.
9

Sample eLabels Modular Design Functionalities (1 of 2)
Companies must make independent decisions on which eLabels design elements they wish to implement.
Sample eLabels Design Functionalities
Sample Modular Design Component
Foundation
Information currently
on paper labels
electronically
Enhance
Information
content and
delivery
Add
Functionality
# Description
1
Simple and immediate information access for users of the system at the site, home, or
other clinical setting
X
2
Accessible via portable devices, web computers, etc. (existing means for accessing
information)
X
3
User Interface with accessibility tools (font size, colors, etc.) and country-required
languages
X
4 Validated, compliant system with data privacy and secure access X X X
5 Complete audit trail of labels and changes on a per kit basis X X X
6 User interface with multiple format options (text, instructional videos, icons, etc.) X X
7
Ability to electronically verify the correct investigational product is given to the correct
patient in the correct clinical trial
X X
8
Improved information and added functionality that can result in improved medication
compliance
X X
9
Ability to provide content updates (expiry dates, changes in regulatory requirements,
changes in dose or dosage regimen, other product-related information) in real-time with
the potential for end-user acknowledgment and without requiring manual label changes
at the site/container level
X
10

Sample eLabels Modular Design Functionalities (2 of 2)
Sample eLabels Design Functionalities
Sample Modular Design Component
Foundation
Information currently
on paper labels
electronically
Enhance
Information
content and
delivery
Add
Functionality
# Description
10 Potential to provide notification of safety/recall issues quickly X X
11
Ability to integrate with other systems to streamline both Sponsor processes (e.g., label
creation/approval, QA/QP release, etc) and Site processes (e.g., receipt, assignment,
accountability, etc)
X X
12
Enhanced connectivity to enable communication between the patient/site and sponsor and
provide access to information
X X
13
Ability to link to learning modules and other relevant Clinical Trial tools (e.g., ePRO and
eConsent)
X X
14
Late stage and/or study-specific customization allows for shared/pooled supplies across trials,
sites, and/or countries
X
15
Sensor features in the eLabel for temperature, motion, container opening, product use, etc. to
facilitate monitoring of storage conditions and patient compliance
X
16 Ability for user to acknowledge alerts/messages in real time X
17 Ability to send reminders to end users (i.e., reminder to take study drug to patient) X
18
Robust drug supply tracking capabilities that automate the management of inventory by
leveraging the eLabel technology
X
19 Ability for user to select Fahrenheit or Celsius X
Companies must make independent decisions on which eLabels design elements they wish to implement.
11

eLabels Stakeholder Analysis:
Design Elements Benefit Multiple User Groups
Element # and Brief Description
Patients &
Caregivers Sites Sponsors
Health
Authorities
1. Simple, immediate information access anywhere X X
2. Access via portable devices X
3. User interface with accessibility tools X
4. User interface with multiple format options X
5. Ability to differentiate labeling for different trials X X
6. Improved information/functionality to aid medication compliance X X X
7. Real-time updates without changing label on each container X X X
8. Integration with other systems to aid Sponsor and Site processes X X X
9. Potential to provide notification of safety/recall issues quickly X X X X
10. Validated, compliant system with data privacy & secure access X X
11. Connectivity to patient/site to provide access to all information X X
12. Linkage to learning modules and other tools X X
13. Complete audit trail of labels and changes per container X X
14. Late stage customization to share supplies across studies/sites X X
15. Sensor features in smart packaging X X
16. Ability for user to acknowledge alerts/messages in real time X X
17. Ability to send reminders to users X X
18. Robust drug supply tracking capabilities X X X
12

eLabels Design Implications and Challenges
eLabels are expected to provide many benefits to each of the following
stakeholders: Patients, Investigators, Health Authorities, and Sponsors.
To achieve the benefits of eLabels, companies may have to overcome certain
challenges, including:
• The eLabel, along with the supporting infrastructure and processes, needs to be designed to meet
GCP and GMP principles. Reducing the printed label content is not yet a viable option in all
geographic locations.
• Per 21 CFR Part 11 and Annex 11, the eLabels system design must incorporate data security, patient
privacy, and a thorough, documented Risk Assessment.
• Importation and custom processes will need to be considered in the implementation of eLabels.
13

Conventional
Clinical Labeling
03

Approach Overview: Document Conventional State Clinical
Labeling
3 Conventional Clinical Labeling
Purpose:
Accurately capturing the conventional state clinical
labeling process, systems, and roles involved will provide
a snapshot of existing business context, systems, and
stakeholders at your company. After creating a vision for
a potential clinical labeling approach with eLabels at
your company, you can then modify the existing state to
meet that vision.
Key Considerations:
• Consider the generic Conventional State process map
provided as simply a reference. It is anticipated that
companies may want to go into additional levels of detail and
modify the reference process map significantly to accurately
capture their company’s conventional state processes.
• When developing conventional state process map(s),
consider including roles, and systems within the map in
addition to roles and systems inventories to quickly reference
conventional state.
Action Steps:
Outputs:
• Conventional state clinical labeling process map
• Conventional state clinical labeling systems inventory
• Conventional state labeling roles & resources
Templates(s) and Reference Material(s):
Document Conventional
State Clinical Labeling
Process Tailored to Your
Company
Create Inventory of
Systems Conventionally
Used in Clinical Labeling
by Your Company
Create List of
Conventional Roles &
Resources in Clinical
Labeling at Your
Company
Template:
Systems Inventory
Template:
Roles & Resources List
15

Conventional Clinical Labeling Label Process Map (1 of 2)
* Representative, High-Level, Multi-country booklet, using IVR/IRT
16
*Notes: For simplification, steps and swim lanes may be combined or omitted. Map is intended to depict a representative conventional state across companies.
Clinical
Clinical Supplies
Label Group /
Librarian
Label
Vendor
Packaging
(Internal or CRO)
Country or CRO
QA / QP
Distribution
1.0 Start:
Clinical develops
Protocol via
Clinical System
2.0 CS interprets
protocol and generates
master label text
3.0a Label
System up
to date?
3.0b Provides
country regulations &
phrase translations
No
4.0 Librarian updates
Label System with
phrases (including
translations)
5.0 Label group
creates label using
regulations and
phrases via Label
system
Yes
6.0 Label Vendor
formats Booklet
Label
7.0 QA (or CS
group/country
affiliate) approves
Label
9.0 CS develops
links and RANDS
10.0 Label Group
(or CS group)
creates variable
text portion of the
labels via IVR
10.1 Is *aux” label
needed?
10.2 Label
Group
creates &
prints *aux”
labels
8.0 Label Vendor
manufactures
booklet labels
11.0
Variable
Text Printing
in house?
Yes
No
10.3 See steps
17.1, 23.1, 25.3
on slide 5
12.0 Label Vendor
overprints variable
text onto Booklet
Label
No
13.0 Label
Group overprints
variable text onto
booklet labels
Yes
14.0 Packaging
applies Label
15.0 QA/QP
approves
completed
packaging order
16.0 Distribution
receives Kits (See
Process Map 2 of 2)

Conventional Clinical Labeling Label Process Map (2 of 2)
17
Distribution
Site
Patient
16.0 Distribution
receives Kits
(See Process
Map 1 of 2)
17.0
Is *aux” label
needed?
19.0
Move to
Hub?
No
18.0 Reference
Step 9.1
Yes
18.1 Distribution
or CRO P&L
group applies
aux label
20.0 Distribution
picks, packs,
and ships to Site
No
21.0 Distribution
picks, packs,
and ships to Hub
Yes
26.0 Site
Receives and
manages
inventory
22.0 Hub
receives kits
23.0
Is *aux” label
needed?
25.0 Hub picks,
packs, and ships
to Site
No
24.0 Reference
Step 10.1
Yes
24.1Hub applies
auxiliary label
26.1
Is *aux” label
needed?
26.2Reference
Step 9.1
Yes
26.3Siteapplies
auxiliary label
27.0 Site
dispenses via
IVR
No 28.0
Patient or Site
administered?
29.0 Patient
receives Kits, takes
home Kits for use
32.0 Site reads label
and administers
Investigational
Product
Site
Patient
30.0 Patient reads
Label and
administers
investigational
product
31.0 Patient
returns used
Kits
33.0
Destroyed at Site or
Distribution?
33.1 End: Site
performs
accountability and
destroys used Kits
Site
33.2 End:
Distribution
performs
accountability and
destroys used Kits
Distribution

eLabels in Conjunction with a Universal Printed Label* Is An Efficient Alternative to
Conventional Clinical Labeling
BookletLabel Current State
Full regulatory-
compliant label on
electronic device
eLabel = “The Label”
Minimal content on
physical label to
ensure patient safety
and accurate
dispensing
Universal Printed Label*
Potential Future State
* Reducing the printed
label content is not yet
a viable option in all
geographic locations
4a eLabel Overview
19

A Universal Printed Label is a paper label that contains limited, language neutral information (e.g.
numbers and pictograms), and refers to a label on a higher level in the packaging structure. A Universal
Printed Label includes information required for dispensing medication at the site, safety information and
may also include trial or molecule specific information. There are no regulatory requirements that
preclude repeating the printed label information in an electronic format. However, the long term goal
will be to use the eLabel in conjunction with the universal label. The universal label concept is being
discussed with global Health Authorities and acceptance of the concept is dependent on the
regulations of each country, which are variable. Therefore reducing the printed label content is not yet
a viable option in all geographic locations.
A Universal Printed Label
4b Universal Printed Label
Pictogram defined:
A pictogram is a graphic symbol that conveys its
meaning through its pictorial resemblance. It can also
be defined as a picture that explains with or without
words an instruction. When pictograms are utilized on
the Universal label, it is recommended that the
pictogram be repeated on the eLabel with the
applicable text.
Universal Label Example
20

Example Universal Printed Label
Universal Label Content Drivers:
Safety and Dispensing
Example Label
Component
Description Rationale
Company name Easier to find containers
and call center for
emergencies
Web address Back-up or link on what to
do
Storage conditions
and Keep out of
reach of children
pictograms
Patient safety
Barcode* Provides an eLabel
access point and/or
access to additional
information
Identification #
Identification, traceability
and ensures correct
dispensation
*Example shown is using a barcode. Other access approaches may include RFID, NFC,
eInk, etc.
184736903
Company
Name
www.companyclinicaltrial.com
184736903
21

Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. 22
Universal Printed Label Concept Example: How does it work?
+ =
Secondary Level Label aka
Universal Printed Label
Full Clinical Label via
Smart Device
Packaged Kit with
Example: Simple multi-level kit with an eLabel (single primary unit within secondary unit) Universal label on kit.
Primary level label can be the same as secondary level label in order to limit the number of label configurations required
Primary Level Label

Documenting eLabel Processes
4c Documenting eLabel Processes
Action Steps:
Key Considerations:
• Consider the sample eLabels process map provided as simply a reference.
It is anticipated that companies may want to go into additional levels of
detail and modify the reference process map significantly to accurately
capture the particular company’s desired processes.
• As you’re developing desired process map(s), consider including roles and
systems within the map in addition to roles and systems inventories to
quickly reference the desired situation.
• Assess gaps from the existing to the desired state.
Output(s):
• eLabels process map(s) (see following slides for starting point)
• eLabels systems inventory
• eLabels roles & resources
• Gap Analysis
Purpose:
Accurately capturing desired eLabels
process, systems, and roles will provide a
snapshot of desired business context,
systems, and stakeholders at your
company. After creating a vision for the
use of eLabels at your company, you can
modify the existing situation to meet that
vision.
Document eLabels Process
Tailored to Your Company
Create Inventory of Systems to
be Used in the eLabels Process
by Your Company
Create List of
Roles & Resources in the eLabels
Process at Your Company
23

Clinical
Clinical Supplies
Label Group /
Librarian
Label
Vendor
Packaging
(Internal or CRO)
Country or CRO
QA / QP
Distribution
Clinical Labeling eLabel Process Map (1 of 2)
1.0 Start:
Clinical develops
Protocol via
Clinical System
2.0 CS interprets
protocol and generates
master label text
3.0a Label
System up
to date?
3.0b Provides
phrase translations
No
4.0 Librarian updates
Label System with
phrases (including
translations)
5.0 Label group
creates Universal
label
Yes
6.0 Label group
develops local
language text based
on regulations and
phrases via Label
system
7.0 QA (or CS
group/country
affiliate) approves
Universal & eLabel
9.0 Label Group
prints Universal
Printed Label
8.0 CS develops
RANDS
10.0 Label Group (or
CS group) creates
variable text portion
of the labels via IVR
11.0 Label Group
uploads country
specific language
text to eLabel system
12.0 Packaging
applies Universal
Printed Label
13.0 QA/QP
approves completed
packaging order
14.0 Distribution
receives Kits (See
Process Map 2 of 2)
1.0 Start:
Label Update Required
2.0 Label update
uploaded into
eLabel System
3.0 Label update
transmitted to
steps 24.0 and
28.0
24

Distribution
Site
Patient
Clinical Labeling eLabel Process Map (2 of 2)
14.0 Distribution
receives Kits
(See Process
Map 1 of 2)
15.0
Move to
Hub?
17.0 Hub
receives kits
16.0 Distribution
picks, packs,
and ships to
Site
No
Yes
18.0 Hub picks,
packs, and ships
to Site
19.0 Site Receives
and manages
inventory
20.0 Site
dispenses via IVR
21.0
Patient or Site
administered?
22.0 Patient receives Kits,
takes home Kits for use and
eLabel uploaded to mobile
device
Site
Patient
26.0 *eLabel
uploaded to site
device
27.0 Site reads
eLabel and
administers
Investigational
Product
28.0 Label update
(i.e. Expiry)
transmitted to site
device
29.0
Destroyed at Site or
Distribution?
29.1 End: Site performs
accountability and
destroys used Kits
Site
23.0 Patient reads
Label and administers
investigational product
24.0 Label update (i.e.
Expiry) transmitted to
patient device
25.0 Patient
returns used Kits
29.2 End: Distribution
performs accountability
and destroys used Kits
Distribution
25

Weeks 17-30Weeks 1-16
Illustrative Cycle Time Improvement:
Conventional Model vs. eLabels Model *
Conventional Model
Sequential
QP release
final KIT Ship to site
Clinical
Supplies
packaging
Clinic
dispenses
KIT
Overprint
bulk
booklet
stock
Manufac-
ture Booklet
labels
QA
release
proof if
applicable
Design
and
approve
booklet
labels
Ship
booklet
labels to
packaging
site
QP release
final KIT
Ship to site
QA release
country
specific KIT
eLabel
Upload
country
specific
eLabel to
patient
device
Design and
approve
country
specific
eLabels
eLabels Model
Weeks 2-15
Week
<1
Design
Universal
Printed
Label
and print
Parallel
*Not designed to scale; not all steps individually depicted
Clinical
Supplies
packaging
Green boxes
represent
same
activities
between
conventional
and eLabel
Week 31
Week 16
Clinic
dispenses
KIT
26

▪ A label content Risk Assessment could provide value to help advance
acceptance of eLabels within your company as an alternative to booklet
labels.
▪ The TransCelerate eLabels team identified potential risks and developed
potential mitigation strategies in the following slides.
▪ Each company seeking to implement eLabels should do its own Risk
Assessment based upon the label contents chosen.
eLabels Risk Assessment
4d eLabels Risk Assessment
Disclaimer: TransCelerate provides this sample risk assessment and mitigation alternatives for illustrative purposes only. Each company is
responsible for identifying any risks associated with its clinical labeling approach and mitigating any such risks to a reasonable and acceptable
level. Neither TransCelerate, its employees and agents, nor any other TransCelerate member bears any responsibility or liability for any
damage, injury, or loss resulting from any company’s use of this sample risk assessment and potential mitigation alternatives set out in this
Toolkit.
27

Sample Risk Assessment of eLabels (1 of 3)
# Risk Potential Mitigation/Prevention
1
By only including the expiry date on the electronic
label, there is a risk of being not compliant with EU
requirement (rest of world ok) for expiry/use by end
date to be placed on all levels of packaging.
▪Need to continue advocacy with EU regulators
▪Leverage other technologies – digital display of the
Expiry date or Clear cartons and integration with IRT to
prevent dispensing of expired kit
2
By replacing storage condition (both temperature and
protect from light), precautions, and any other
handling text in the appropriate language, with only a
pictogram, patients and/or investigators could be
unclear on how to store drug product resulting in the
potential for drug degradation.
▪Risk level may be tolerable on the condition that the
pictogram would clearly give the guidance needed
3
By replacing statements such as Keep Out of Reach of
Children with only a pictogram, there may be safety
concerns with the clarity of how the drug product
should be handled.
▪Existing controls such as child-resistant containers and
general knowledge to keep all medication out of reach
of children may be considered sufficient
(statement/text does not provide further safety guards).
This sample assessment assumes use of Universal Printed Label concept.
Note: Each company must make its own independent risk assessment and eLabels decision.
28

4
By replacing statements For Clinical Trial Use Only &
Investigational Drug with only a pictogram, there
could be safety concerns with the clarity of how the
drug product should be handled.
▪Risk level may be tolerable on the condition that the
pictogram would clearly give the guidance needed
▪Electronic version of the label details the caution
statement, plus the caution statements will be contained
in the consent document.
5
By replacing multiple unique identifiers such as the
Packaging Order Number, Batch Number, and
Reference Number with a single unique packaging
reference number, there could be confusion as to the
contents (i.e. customs).
▪Risk level may be tolerable on the condition that one
unique packaging reference number link would work
6
By replacing name, address, and telephone number
of the sponsor, investigator, etc. with a logo and
Website address, it could be unclear who to contact
in the event the need arises.
▪Risk level may be tolerable as website provides contact
information
▪Annex 13 allow for this information to be included on
patient card or other communication vehicles
▪Could possibly also include global contact details on
29

7
By replacing dosing instructions with a pictogram, it
could be unclear how to administer or take the drug
product.
▪Risk level may be tolerable as patient will have
information on device (instructions will be available
electronically).
▪Common for label to contain “Use as directed”
instructions.
▪Leverage site instructions.
8
By replacing the dosage form, product name, potency,
route of administration, and quantity of units with a
unique identifier, it could create confusion as to the
product being administered.
▪Leverage use of a key to describe pictograms.
▪Product name not required for blinded studies.
▪Traceable through trial or packaging number.
9
System failure or outage could prevent patient or site
from accessing the label text.
▪Back-up processes must be established.
30

▪ One model for performing a Risk Assessment is to develop a RIV (Risk Index Value), calculated from the combination
of “Consequences” and “Likelihood”.
▪ Risk scores are assigned an RAG status: Red Amber Green
10-25 RED: Unacceptable risk – Will need elimination/immediate attention
5-9 AMBER: Will need mitigation and/or elimination
1-4 GREEN: No action – acceptable risk
A Typical Framework for Risk Assessments
Individual companies can perform a risk assessment to determine acceptability of risks for their companies.
Consequences
Likelihood
Insignificant
1
Minor
2
Moderate
3
Major
4
Catastrophic
5
Almost Certain
5
5 10 15 20 25
Likely
4
4 8 12 16 20
Possible
3
3 6 9 12 15
Unlikely
2
2 4 6 8 10
Rare
1
1 2 3 4 5
31

eLabels Health
Authority Landscape
05

eLabels Regulatory Landscape
Summary:
The TransCelerate member companies have worked together to discuss eLabels with various Health Authorities. The
basis for selecting the HAs included, 1) level of influence, 2) number of studies conducted in that country, 3)
perceived technology receptivity, and 4) willingness to meet with industry.
Currently there are no regulations that precludes the use of an eLabel. Sponsors are able to utilize technology to
provide the label content in all geographies as long as the printed label meets local regulations. Utilizing a printed
label with reduced content “Universal Label”, along with the technology, may take additional time and require
experimental data for some Health Authority acceptance. In some cases, regulations will need to be modified.
It is our belief that the uptake of the universal printed label in conjunction with the eLabel will increase over time. In
order to drive acceptance, eLabels must be implemented flawlessly, with patient safety at the forefront of the
design. Additionally, implementing an eLabel where allowed and gathering data via patient and site surveys will
further acceptance by Health Authorities. Sponsors can also implement an eLabel in a parallel fashion along with the
traditional printed label for the countries where the regulations prevent removing text from the printed affixed label.
Increasing the use of the electronic version of the label, even when the printed label is available, will aid in
normalizing that the electronic version is the label.
Additional Health Authority meetings in Asia and South America are planned with no firm meeting dates. This toolkit
will be updated with additional feedback upon receipt.
Disclaimer: Nothing in this document constitutes a legal advice or a legal opinion.
5 eLabels Health Authority Landscape
33

Summary of eLabels Health Authority Engagements
EFPIA (Feb 2016)
▪ Expressed that eLabels will be extremely challenging
especially with Annex VI
▪ Stated that a universal printed label would not be compliant
with Annex 13 requirements
▪ Offered to participate in an e-initiatives, cross-Health
Authority meeting to determine implementation options
EMA (Jun 2016) FDA (Oct 2016)
▪ Had no questions regarding eLabel technology or the use of
an electronic means to transmit the label information
▪ Questioned if a pictogram could solely represent the
cautionary statement on the universal label.
▪ Indicated eLabels team does not need to return until there
is something specific to share such as pilot data
EFPIA (Feb 2016)
▪ Open and receptive to eLabels concept
▪ No perceived barriers to implementing eLabels
▪ Would like to see data in Taiwanese patients, particularly
the elderly
▪ Not mandatory to get approval prior to pilot execution
▪ Offered to conduct pilot in Taiwan
TFDA (July & Nov 2016) MFDS (Nov 2016)
▪ Stated the universal printed label would not meet PIC/S Annex 13
requirements
▪ Currently allow additional information via bar code on commercial
label and view eLabel as adjunctive
▪ Has issued draft guidance on pictograms for commercial labels
▪ Would like to see data from Korean pharmacists and patients,
particularly the elderly
Agencies did not appear to have issues with the concept of an eLabels technology
Concerns expressed were related to what would remain on the physical label
34

Summary of eLabels Health Authority Engagements
▪ Appreciated the attention given to e-Initiatives as the direction of the future
and indicated alignment with their and ICH future direction
▪ Indicated general support of the eLabels concept and noted having had
several discussions with individual companies on the concept
▪ Suggested that we be aware of convergence of post-approval studies and
clinical trials
▪ Mentioned that they will be publishing industry non-prescription codes for
Facts table on July 31st. They are also coming out with something on QR
codes/ landing page
▪ We are exploring an opportunity for additional meeting in 2017
Health Canada (Jun 2017)
EFPIA (Feb 2016)
MHRA (Jun 2017)
▪ Collaborative and encouraged continued dialogue
▪ Indicated they while they are bound by regulations for what is
on the physical label, there may be situations such as Clinic run
studies where some flexibility may exist
▪ Will accept a dual approach but a discussion approx 3 months
before is needed. (Ensure connection with Simon Lewis)
▪ Indicated they are pragmatic about the direction we need to
head
▪ No current plans to change from Annex VI when issued
▪ Implications of Brexit are unknown at this time
▪ Agreed re-labeling provides opportunity for error. Would have
accepted IRT control of expiry date, but Annex VI precludes
that
▪ Liked the promise of eLabels and additionally, the opportunity
to enrich the label (eg, instructional videos and recall
notifications)
▪ Provided a caution to not repeat the information on the
physical label in a video
▪ Think through emergency situations
▪ Continued agreement with eLabels direction
▪ Supportive of our engagement with patient/site groups as a way to provide
their perspective to other stakeholders
▪ Pilot data will be useful to demonstrate regulations can be met using modern
tools
▪ EFPIA is working with EMA to develop a reflection paper on a commercial
eLabels technical pilot. EFPIA will share this with us.
EFPIA (Jun 2017)
Agencies did not appear to have issues with the concept of an eLabels technology
Concerns expressed were related to what would remain on the physical label
35

Approach for Introducing the eLabel
2a. Dual paper
and eLabel in
specific
countries
and/ or
2b. Universal
printed label
and eLabel in
other countries
1. Current State
Paper (booklet)
Label
3. Collect
and provide
global data
on all
approaches
Iterate to
enhance
based on
pilot data
4. Fully
electronic
label utilizing
a universal
printed label
in all
countries
Increasing functionality and benefits for sponsor companies, patients and sites
36

eLabels From the Site
and Patient Perspective
06

The Site and Patient Perspective: Overview
Sites and patients are key stakeholders in the eLabels process. As stated in prior sections, the
printed (booklet) label, while meeting regulatory agency requirements, has limited utility for
patients and sites.
As part of this initiative, TransCelerate reviewed patient surveys previously conducted by
International Society of Pharmaceutical Engineering (ISPE) and also engaged with patient and
site advocacy groups. The purpose of these engagements was to gain feedback on the
current use of paper labels and on eLabels concepts including an example proof of concept.
A list of the engagements is below.
6 eLabels from the Site and Patient Perspective
1. TransCelerate Site Advisory Group Meetings (May 2016 to Apr 2017)
2. TransCelerate Site Advisory Group eLabels Simulation Meeting (NYSIM) (Mar 2017)
3. “Patient Perceptions of IMPs.” Pharmaceutical Engineering 36, no. 1 (Sadler-Williams, Esther. January/February
2016): 22–23.)
4. “Patient Perceptions of Investigational Medicinal products 2015 Surveys in EU (and China)” Esther Sadler-Williams,
8th March 2016, ISPE EU annual meeting.
5. TransCelerate CISCRP Patient Survey (unpublished) (August 2016)
6. TransCelerate Patient Focus Group Meetings (Sept 2016 to Feb 2017)
38

Insights from
Investigative Sites

Over 65 site interviews in EU, US, Latin America and Japan1 expressed support for
eLabels and acknowledged the potential to:
Insights on eLabels from Investigational Sites
1TransCelerate Site Advisory Group and Lilly site interviews (SCRS)
2TransCelerate eLabels Site Advisory Group Sept 2016
Site Advisory Group (n=12)2
Sites also expressed dissatisfaction with
current labels (booklet and single panels)……
“Difficult to locate
and select correct
container based on
Kit ID”
“A link for patients to
access information on-
line would be
premium”
“We’d never
dispense something
like this in a retail
setting”
When shown eLabels prototypes, sites positively responded with:
• Unanimously liked the concept
• “Simple and clean”
• Liked “push” real time updates and notifications
• Making it language friendly allows patients to focus on what is useful to them
• Extremely helpful to have detailed dosing instructions
…..and asked for the following information
• Patient dosing reminders
• Electronic ways to improve efficiency and accuracy of drug
accountability
• Dosing videos and pictures which serve as reminders/information when
the patient is at home
• Machine readable ways to verify the site picked the right container
• Sites indicated patients are motivated and most will use an electronic
device to obtain information
“Patients rip it off
or don’t even
open it”
6a eLabels Site Feedback
▪ track compliance
▪ provide notification to patient
▪ allow integration with patient diaries
▪ provide access to supportive videos
▪ reduce human error and workload
▪ enhance readability of the label
▪ eliminate relabeling
▪ provide detailed dosing instructions
“It doesn’t contain
information
needed by
patients”
40

eLabels Site Advocacy Group (SAG) Simulation Engagement
Site Advocacy Group Simulation
TransCelerate engaged in a unique opportunity in March 2017 to simulate using an eLabel as
part of an Investigator meeting and an initial patient visit.
Location: The City University of New York
Simulation Center (NYSIM)
An organization which uses real life clinical simulations to
train first responders and medical staff. Their intent is to
improve communication, patient safety and the quality
of healthcare through a unique training approach.
Objective of Simulation
Use simulations of eLabels-related processes and
related tools to understand how they could be used
by clinical sites to enhance their experience and
improve their ability to perform clinical trials and
engage with patients.
41

Site Feedback from the Simulation Exercise
X
Technology
averse is not
just the elderly
Encourage
patient
engagement
with the
technology
Consistency across
sponsors is considered
advantageous by sites*
Enable site personal
to be the experts
Space/storage
at sites is limited
and valuable
Enable site
(engagement)
communication
with a patient
Sponsors can
help sites
help patients
Connect to other
systems & minimize
hardware/ software for
a study
*TransCelerate is not set up to develop standards nor has an
objective to develop consistency across companies
42

Site Feedback from the Simulation Exercise: Technology
Connect to existing systems
Connect new technologies to systems
the site is already using to allow
efficiencies. Eg, IRT systems
Minimize hardware/ software across a study
Multiple approaches, hardware, software, sign-
ons “would be daunting” for both the patient
and site. Training complexity, decreased
comprehensive and risk of error could occur.
(eg, eDiaries, drug accountability, receipt
verification, eLabel)Encourage patient engagement
with Technology
Look for meaningful ways to allow the patient to have
regular interactions with the technology (eg, alarms,
site adding visit reminders). Avoid overcomplicating
or non-value add activities
End to end process including saving
data for site records
Information captured by a sponsor or through
the applications, may also need to be
maintained in site records.
43

Site Feedback from the Simulation Exercise: Sites and Patients
Space/storage at sites is limited and
valuable
Tools shared were perceived as advantageous
because they could facilitate connection with
the patients. Sponsors could potentially enhance
that by including site/patient connection
opportunities.
Enable site (engagement)
communication with a patient
Instructions/training should be simple, clear and printable. Provide sufficient training to allow site
staff to become the experts for patient facing technologies. Ensuring sites can answer questions
quickly will instill patient confidence in the technology. Additionally, while sites recognize that there
is a need to move away from paper, they did request the ability to have a printed version they could
hand out to patients that may need it.
Enable site personnel to be the experts
Entire rooms are dedicated for sponsor study
related storage. Shipping packaging, hardware
and other sponsor provided items are
opportunities to look for efficiencies. This is even
more complicated by a site that works with
multiple sponsors.
44

Site Feedback from the Simulation Exercise: Additional Learnings
Transition takes time
Military, those with limited finances, and those concerned
with patient privacy should also be considered. Providing
print-outs (and perhaps other ways) to ensure their
participation is a viable option. Sites encouraged the
ability to provide printed handouts regardless of
technology adverse or not.
Technology averse is not just the elderly
….is considered highly valuable as it has the potential to:
1) minimize the time for a site to learn and maintain knowledge on an app or hardware
2) minimize the potential for errors which could occur as a site deals with multiple approaches
3) decrease storage requirements to limit what is needed or harmonize across sponsors is of great value to sites.
Consistency across sponsors*
Sites were extremely supportive of the
concepts shared and urged a continued
move forward as they saw value for patients
and sites. They shared advancement will
take time and were appreciative that
TransCelerate is working on this and are
visiting with the regulators as they (sites) will
be audited and they must explain the
approach.
X
*NOTE: TransCelerate is not set up to develop standards nor has an objective to develop consistency across companies
45

Insights on eLabels from Patients
Patients are considered a key stakeholder for an
eLabel. To gain patients’ perspective, TransCelerate:
6b eLabels Patient Feedback
• Reviewed patient survey outcomes conducted by ISPE
• Considered a general patient survey conducted by CISCRP on
behalf of TransCelerate
• Reviewed feedback from a pilot conducted by Janssen
• Engaged with a Patient Advisory Group (organized by CISCRP) to
discuss and provide feedback on an eLabels proof of concept
47

ISPE Surveys
5,000+ previous clinical trial patients surveyed indicated:
(3,000+ US, 109 EU and 1,935 China)
▪ Written and verbal instructions were valued most to ensure compliance
▪ The most helpful instructions via demonstration or verbally from site personnel
where patients can ask questions
▪ Most preferred means to obtain information:
➢ Email (EU and US)
➢ Text message and postal mail (China)
Patient Survey Outcomes
1Patient Perceptions of Investigational Medicinal Products 2015 surveys in EU (and China), Esther Sadler-Williams 8th March 2016, Frankfurt
TransCelerate/ CISCRP Patient Survey
N= 3045 (NA, AP, EU, LA)
▪ 93% of individuals are comfortable with electronic devices (2817 out of 3045)
▪ Other than from their doctor or other healthcare professional, the 2nd and 3rd most
preferred methods to receive information on their clinical trial medicine was online and
email respectively
▪ 87% of 65 and older are comfortable with electronic devices
48

Patients Reported
• 84% of subjects scored smartphone use as
easy to very easy, despite only 25% having
smartphone experience
• 92% indicated eLabels updates easy to
understand
• 72% of participants proactively consulted
eLabels content in addition to reading the
notifications.
• Overall positive feedback on ease of using
eLabels and clarity of eLabels update
notifications
• Being notified of dosing changes (eLabels
updates) was considered the most
important advantage of the eMeds
technology
Janssen eMeds/eLabel Technical Pilot 1
Objectives
• Technical evaluation of the different eLabel and eMeds components
• Evaluation of user-friendliness and satisfaction of subjects and sites
1Janssen eMeds/eLabel Technical Pilot
2 SUBJECT SATISFACTION SURVEYS
+ INDIVIDUAL SUBJECT INTERVIEWS
12 DAYS24 VOLUNTEERS
3 LABEL UPDATES
• 18-40 yr
• 40-65 yr
• > 65 yr
• Dutch
• French
• English
• “1 morning & 1 evening capsule ”
• “2 morning, 1 noon & 2 evening
capsule”
capsules”
capsules”
Morning
Noon
Evening
Day 5
Day 12
Final visit
1Vanaken H. Digitally Enhanced: Janssen Drives Effort to Bring Suite of ‘Smart’ Clinical Trials into Practice in 2017
(applied Clinical Trials Dec 2, 2016) http://www.appliedclinicaltrialsonline.com/digitally-enhanced-smart-trial-
platform.
49

TransCelerate Patient Advisory Group Feedback
TransCelerate eLabels initiative engaged a Patient Advisory Group with the purpose of
gaining feedback on eLabels concepts.
• Engagements were both virtual and F2F
• Advisory Group included 12 individuals from North America, EU, AsiaPac regions.
• Meetings were conducted over a 1 year timeframe
Concepts discussed with the Patient Advisory Group included:
• Perspectives on usability of current printed labels versus an eLabel
• Feedback on the TransCelerate eLabels example eLabel proof of concept (See Section 7c
eLabels Use Cases and Example of an eLabel
• Feedback on pictograms
The following slides represent the feedback received.
50

Patients Advisory Group expressed dissatisfaction with current
labels (booklet and single panels)
“Doesn’t contain the
information I need”
Most patients learned about their study medication through the informed consent
document and from study staff
“Font is too small”
“Booklet label was too
difficult to open”
Caregiver “labelled
bottles with a magic
marker to highlight when
to take pills from
different bottles”
Investigator told me
“don’t bother to open it
(booklet) that is just the
technical information.”
51

Patient Advisory Group provided positive feedback on the eLabel
proof of concept and gave feedback in these categories
Access
The Patient-
centric eLabel
Supportive
Information
Contacts
Content
Design &
Features
Pictograms
52

Patient Feedback on Proof of Concept
Design and Features
Patients agreed with foundational content in the proof of concept they were shown and
additionally suggested including
• Medication Name
• Dosing instructions (especially important when taking multiple medications and/or IMP/placebo from
multiple containers)
• Sponsor name
• Contact Information (Study nurse, Patient Advocate - specific role for all NIH studies)
• Adverse event information
Content and Contacts
Patients liked:
• “Clean and simple” design – (colors, layout, bolded headers, etc)
• Search function is helpful
• Ability to select their native language, even when traveling
• Update functionality, notifications
Patients suggested:
• Ability to easily make call from contact information
• Notifications (e.g., texts) so they don’t have to be checking for updates
• Ability to scan only one time
• Individual location and preference information could be pulled from phone settings
53

Patient Feedback on Proof of Concept
Patients expressed a desire for the
following information
• Side Effect Information
• Video on how to take medication
• Single App for E-Label and medication
diary
Supportive Information
• Use of an eLabel can allow increased
ease of access for patients with
physical, visual or auditory challenges
• Want access for other family
members/caregivers
• Access to study medication name
and dosage information post study
• Accessible by emergency room,
hospital personnel
Access
Pictograms
• Consistency across pictograms is helpful: consider
• Shapes (e.g. triangles and squares)
• Use of X versus a slash to indicate “do not”
• Outlines around pictograms (not needed)
• Pictograms on a white (vs black) are easier to recognize
• Use patient centric text (as opposed to clinical /sponsor
terms)
• Leverage site staff to provide support/education to
ensure understanding of pictograms
• Simplicity in a pictogram is preferred versus overly
complicated pictograms
• Use of color was perceived to be beneficial
• The availability of a “pictogram glossary” was considered
as helpful
• On the universal label, ensure the pictogram for
connection to the eLabel (eg, Barcode, etc) indicates
that the patient will be able to obtain additional
information through that access
54

Trends Regarding Seniors and Technology
During TransCelerate stakeholder engagements, stakeholders asked a repeated question on seniors’ ability to use this
new approach.
Electronic usage trends indicate that there is an upward trend for seniors acceptance of technology. However,
considering seniors ability (and technology adverse individuals) to have and/or use the technology should be a
consideration for any eLabels solution.
Resources Results
TransCelerate (CISCP)
Patient Survey
• 87% (717/827) of those 65 and older were are comfortable using electronic devices (laptop, tablet, smartphones)1
AARP factsheet • Adoption of a mobile device (smartphone or regular cell) among the 50+ in the US is 89%. Smartphone penetration is at 55%
. Age groups for senior smartphone ownership: 50-59 is 73%; 60-69 is 54% and the 70+ age group is 29%. 2.
• Nearly nine in ten (89%) US adults over 50 own some type of mobile device and nearly three quarters of adults age 50-59
(73%) own a smartphone3
Pew Research Center
papers
• US senior (65+) internet use has climbed from 14% in 2000 to 64% in 20163
Australian Communication
and Media Authority
• Internet use in AU seniors (65+) is on the rise, increasing from 65% rate in 2011 to a rate of 79% in 2015)4
Internet users in the UK:
2017
• Recent internet use in the 65 to 74 age group has increased from 52% in 2011 to 78% in 2017, closing the gap on younger age
groups. 5
1. TransCelerate Global Patient Survey (September 2016 unpublished)
2. Anderson, O. (November 2016). 2016 Technology Trends among Mid-Life and Older Americans. AARP Research. Retrieved from: http://www.aarp.org/research/topics/technology/info-2016/2016-technology-trends-older-americans.html
3. Internet and broadband fact sheet (January 2017). Pew Research Center. Retrieved from: http://www.pewinternet.org/fact-sheet/internet-broadband/
4. Research and Analysis Section (August 2016). Digital Lives of Older Australians. Australian Communication and Media Authority. Retrieved from: http://www.acma.gov.au/theACMA/engage-blogs/engage-blogs/Research-snapshots/Digital-lives-of-older-Australians
5. Internet users in the UK: 2017: https://www.ons.gov.uk/businessindustryandtrade/itandinternetindustry/bulletins/internetusers/2017
55

Patient/
Caregiver
device set-
up
and testing
Assess
Patient/
Caregiver
technology
Potential activities to consider prior to the
patient/caregiver viewing the eLabel
A potential 2 step process to consider
1 2
6c eLabels Site and Patient Considerations
56

Assess patient’s technology – activities
1. Determine if a company or site provides a device or if they rely on patient using their own device
a. What are the potential considerations for the device?
i. Verify operating system (e.g. Windows, Android, iOS, etc.)
ii. Assess storage capacity for application on device and subsequent updates
iii. Verify access to data services
a. Wi-Fi/Internet Access at home?
b. cellular data plan?
b. Assess barriers that would prevent patients from using this technology
i. Does the patient have access to a device?
ii. How comfortable are they with using a device for visualization, search, back-up plan, etc. ?
2. Verify access to other services which may be required as a ‘back-up plan’
a. Cell phone/land phone line for calling support
b. Internet/computer/browser for accessing eLabels data via a website with a unique identifier
c. What if the device (e.g. phone) is updated after visit to the site, and now the device is no longer compatible with the
application?
d. What if the patient loses their device account (e.g. stops their services) on their digital account access after starting in the
trial?
e. What if phone is upgraded/traded in?
1
57

Patient device set-up and testing – Sample activities
1. Site provides ‘Guided Set-up’ of device and eLabel for patient
a. Selection at site for ‘country of participation’ by site
b. Selection of preferred language of the participant
c. Selection of Text size if applicable
2. Assist in download of the application (from app store) during visit, if application is used
3. Verify eLabel is viewable on device and application is functioning
a. If strategy is ‘push’ of label to phone (to be visible without internet connection) test this?
4. Describe or train patient on scenarios when an ‘update’ to the e-label is needed (what does the patient
see/expect/interactions)
5. Review follow-up / back-up plan information
6. Document device testing / patient education and acceptance of the ‘technology and processes’ around the e-label
7. If sponsor provides device, usage information such as the following must be communicated:
a. How to power on device
b. How to charge device
c. How to lock device
8. Check with your internal device/eCOA (electronic clinical outcomes assessment)/patient diary team for additional
device considerations
2
58

Patient and Site Training Considerations
• Training on the use of an eLabel may be required
• “Easy start up” handouts may be helpful, along with help desk information
• Clear instructions regarding how to access an eLabel and what to do if a problem arises may be
helpful
• Training of the site may be required and may need to be robust enough to allow the site to become
the trainer for the patient to ensure competency of use.
• During the initial visit where the patient/care giver receives the technology, it may be helpful to assess
the effectiveness of patient / care give training.
• A demonstration of patient and/or caregivers competency in the use of an eLabel prior to leaving
the site may be an additional consideration.
6c Labels Site and Patient Considerations
59

eLabels Technology
Approach
07

Introduction
The eLabels Technology Approach section provides guidance on potential technology options and
processes that companies may consider when implementing eLabels.
Included in this section:
1. A high-level technology landscape analysis (technology assessment) process that includes the
following steps
o Identifying potential features that may be part of an eLabels solution
o Exploring technology options to implement those features
o Evaluating solution considerations and implementation considerations for each option
2. High level considerations for technology architecture and system integration needs.
3. Use cases and an example wireframe that illustrates the potential functionality for an eLabel
o View eLabel
o View eLabel updates
o Search eLabel
o Change User preferences
o Back-up plan, if technology fails
7 eLabels Technology Approach
61

Technology
Landscape
Assessment

High Level Considerations Regarding eLabels Technologies
A company might wish to consider whether the:
Solution is based on a company’s business practice, solution
architecture and infrastructure.
Approach fits today’s current labeling needs and has the ability to
expand to provide additional enhancements, capabilities and
functionalities.
Approach considers options that can stand alone but provides
enhanced benefits if used across the clinical supply chain.
Solution considers mechanisms that can be flexible, innovative,
and scalable.
7a Technology Landscape Assessment
63

Technology Landscape Assessment Process
STEP 1:
Identify available
potential features
that may be part of
an eLabel solution
STEP 2:
Explore technology
options to implement
those features
STEP 3:
Evaluate solution
considerations and
implementation
considerations of
each option
STEP 4:
Evaluate back-up
options
64

A. What will be applied to
packaging?
B. How will label be read and
understood?
C. What label content will be
embedded in packaging v/s
information cloud?
D. What method will be
used to update and review
label content?
E. How will patient and
sites be notified of label
changes?
65

A. What will be applied to packaging?*
Barcodes
A1 QR bar code
A2 2D data matrix
A3 Bokodes
Interactive Displays
A4 LED display
A5 Electronic
paper display
Augmented Reality
A6 Augmented
Reality
Electronic chips
A7 RFID
A8 Bluetooth
A9 NFC
Interactive Buttons
A10 Audio button
A11
Video/Hologram
button
* Technologies listed are based on a 2015 Technology Landscape Assessment and may not be inclusive of all viable options. Sponsors may wish to
consider available options other than those listed here for illustrative purposes.
66

B. How will label be read and understood?*
Hardware
B3 Smartphone
B4 Handheld scanner
B5 Fixed scanner
Ownership Options
B6 Bring your own
B7 Sponsor provided
B8 Vendor/Site provided
Software
B1 Developed by Vendor
B2 Developed by Sponsor
* Technologies listed are based on a 2015 Technology Landscape Assessment and may not be inclusive of all viable options. Sponsors may wish to
consider available options other than those listed here for illustrative purposes.
67

C. What label content will be embedded in packaging versus
information on cloud?*
All
Content
ALL
English
only
ALL
Static
only
On packaging/On cloud
C1 All information on label/ None on cloud
C2 English only on label/ All other info on cloud
C3 Reference to cloud record on label / All other info on cloud
C4 Static content on label / All other info on cloud
* Technologies listed are based on a 2015 Technology Landscape Assessment and may not be inclusive of all viable options. Sponsors
may wish to consider available options other than those listed here for illustrative purposes.
68

D. What method will be used to update and review label content?
Old
New
Physical
replacement
Old
New
Wired
Connection
Old
New
Internet
Connection
Old label
New Label
Method of Update
D1 Replace
D2 Local reprogram
D3 Remote reprogram
D4 Update on cloud
Method of Review
D5 On site review
D6 Remote review
D7 Vision detection
D8 Review on cloud
* Technologies listed are based on a 2015 Technology Landscape Assessment and may not be inclusive of all viable options. Sponsors may
wish to consider available options other than those listed here for illustrative purposes.
69

E. How will patient and sites be notified of label changes?*
Push
E1 Email
E2 Text
E3 Voice
E4 Packaging alert
Pull
E5 Rescan
E6 Check on website
E7 Query button
E8 Call center
* Technologies listed are based on a 2015 Technology Landscape Assessment and may not be inclusive of all viable options. Sponsors
may wish to consider available options other than those listed here for illustrative purposes.
70

Solution Considerations
Is the technology
safe for patients?
Does the
technology
comply with
Health Authority
regulations?
Is the technology
easy to use?
Does the
technology
improve sponsor
efficiency?
Does the
technology
improve site
effectiveness?
71

Implementation Considerations: Example Questions
Is there special
training and
security
needed?
Durability and
can it withstand
external
environment
factors?
What is the
effect of the
different sizes
and shapes of
packages?
Is a replaceable
or rechargeable
power source
needed?
What impact is
there on
resource
usage?
What is the test
approach of
the solution?
Can this work
throughout the
different clinical
stages? (e.g.
vendor, site,
sponsor, etc.)
How mature is
the
technology?
How reliable is
the
technology?
How complex is
the technology
solution to
implement?
What is the cost
to implement?
Who will
implement the
technology?
(e.g. vendor)
72

Key Consideration – Redundant Systems and Back-up
Plans
Potential eLabel Failure Points
• Unreadable Label
• Device
inaccessibility
• Loss of power
• Broken device
• Lost device
• Server
• Loss of internet
• Loss of wireless
signal
• eLabel
application bug
• eLabel
application is not
properly installed
on user’s device
Hardware Software
Signal Connectivity Universal Label
• Business continuity plan developed
• URL printed on universal label to allow user
to enter a unique identifier (e.g. Kit
Number) to retrieve label
• Once label is scanned, it is available in
the device history off-line
• Can be downloaded to local electronic
and/or hard copy storage
• Call number on patient card for trouble
shooting and support on device /
application usage
• Retrain user
Potential Solutions
Digital Examples
Human to Human Examples
eLabels solutions will need to comply with 21 CFR Part 11 and Annex 11 Computerized Systems
73

eLabels
Technical
Architecture

What is Technical Architecture?
Technical architecture identifies the grouping and interaction of technology components.
It enables data, application infrastructure, hardware, and custom and packaged software
to unify in a coherent structure of components and interfaces.
Key Considerations
Productivity
Flexibility and
Maintainability
Risk Reduction
Usability and
Operability
Portability
Consistency can
help reduce the
learning time of
application
developers by
providing a
common
framework from
which to work.
A consistent
structure and
shared vision can
help improve
flexibility and
maintainability.
The architecture
encourages
developing
applications, with
consistent
behavior and
interfaces,
resulting in user-
friendly
applications.
A well-built
architecture can
help isolate
technical
complexities from
the application.
A well-defined
architecture can
help improve the
portability of the
architecture and
applications and
its ability to
interact with other
delivery vehicles
and applications.
7b eLabels Technical Architecture
75

Why create a Technical Architecture?
• Following the principles of the toolkit, the technical architecture provides companies a high-level
guidance on which potential systems have a relationship to the eLabels system itself. The eLabels
system is the software that will generate the eLabels content.
• The technical architecture offers some considerations for what companies may want to consider
when developing an eLabels system with the understanding that such a system may have touch
points to other systems – whether internal or external. Implementing an eLabels system will have a
big impact for companies as the system may likely be a new one (or at least a significant update
to an existing system).
• The technical architecture will minimally provide a suggested foundation of an eLabels system
implementation. It can also evolve to a prospective technical architecture that includes
forward-thinking integration with other systems that can ultimately enhance or add-on for patient
centricity
Technical architecture can impact the development of an eLabels system
76

eLabels is an integrated component within the Study Conduct
Business Process
77

An Example eLabels Integrated Architecture
78

An Example High Level eLabelS Technical Architecture*
Foundational eLabel
*Technical Architecture and
capabilities will vary based on
company approach
** As the architecture is
enhanced, companies may
add capabilities
Example Enhancements**
79

Key Systems for Integration Consideration
System Potential Integration Points
Enterprise Resource Planning
(ERP) System(s)
▪ The eLabels system could interact with the ERP system via the demand and planning tool to provide better clinical
supply inventory management potentially reducing wastage and the need for expiry extension of supplies.
Clinical Supply
Demand/Planning and
Distribution System(s)
▪ The eLabels system could enable supplies for different protocols to have common packaging with a Universal
Label and be kept at the same depot/distribution hub until needed.
▪ When needed by a particular protocol, the protocol identifier could be added physically and/or electronically
(just-in-time / on-demand labeling).
▪ This may reduce overstock and stock-out issues.
Interactive Response
Technology (IRT)
▪ The randomization and clinical trial material management system which allocates correct investigational product
(IP) to individual patient per randomization assignment can integrate with the eLabels system to streamline
traceability of IP pack or kit to a given patient(link pack/kit identifier with patient identifier).
Label Management System(s) ▪ The eLabels system could streamline content creation and approval workflows for initial and updated labels.
Regulatory Systems ▪ The eLabels system could enable Regulatory content management and allow customization for country-specific
regulatory content in the elabels.
Sensor Systems ▪ Smart packaging and sensor systems (eg. Temperature or motion sensors) could integrate with the eLabels system
to track how any particular pack or kit was stored/handled throughout its lifespan and detect investigational
product usage as a way to capture protocol compliance.
Site Portals/Shared Investigator
Portal
▪ Accessibility to site portal via the eLabels system would tie drug supply to a particular site and allow quick access to
relevant information.
Drug Accountability and
Tracking System(s)
▪ eLabels system integration can enhance the tracking of clinical supply inventory from manufacturing site to
depot/distribution hub to site to patient, help facilitate recall of clinical supply if needed and track study site
performance based on the quantity of investigational product used by the number of patients at any particular
site.
80

eLabels Use Cases
and Example of an
eLabel

Example eLabels Use Cases
eLabel Backups
Change User Preferences
View eLabel
View eLabel update
eLabels Use Case and Example eLabel Overview
7c eLabels Use Cases and Example of an eLabel
As part of the TransCelerate eLabels initiative, a series of use cases were identified as a basis for development of an example
eLabelS (wireframe). These use cases and the resulting example wireframe are intended to provide a glimpse into the “art of the
possible” for an eLabel. Each company should identify/ consider their own use cases.
Search eLabel content
Describes the process of a user viewing
eLabels information
Describes the process of searching for
eLabel content
Describes the process of a user
changing the eLabel system
preferences (eg, language, font size)
Describes digital, non-digital and
exception back-up processes
Brief Description
Describes the process of a user
viewing an update to eLabel
information
1
2
3
4
5
82

View eLabels
Use case describes the process of an actor viewing the eLabel content
Points for consideration:
• Initiating Actors can be Patient, Caregiver, Pharmacist, Site, Customs, or Distribution
• Companies to consider how to showcase information, e.g. Static vs collapsible
categories
• Should all data elements be viewable on one screen?
• Should important information for the patient not be collapsible?
• Should Drug & Usage information and Warning data elements be static?
View eLabel Use Case and Design Considerations
1
83

View eLabels Update
Use case describes the process of an actor viewing an update to eLabel
content
Points for Consideration:
• Initiating actors can be patient, caregiver, pharmacist, or site
• Should information be received via push and/or pull systems?
• Should you require users to acknowledge eLabel updates ?
View Update Use Case and Design Considerations
2
84

Search eLabels Content
Use case describes the process of an actor searching eLabel content
Points for Consideration:
• Initiating actors can be patients, caregivers or site
• Company to decide level of search complexity, eg. Caps should not cause issue with
searches
Search Content Use Case and Design Considerations
3
85

Change User Preferences
Use case describes the process of an actor changing the eLabel
system preferences
• Initiating actors can be patient, caregiver, pharmacist or site
• Sample user preferences include language and font size
• Company should consider ways to capture the users participating country,
eg. If country selection should control language options
Change User Preferences Use Case and Design Considerations
4
Notes: Language settings and Regulatory compliant label content are subsets of this use case.
86

eLabels Back-up: Digital
Use case describes the process of actors viewing digital
eLabel information on their secondary digital device
• Initiating actors can be patient, caregiver, pharmacist, site or Distribution
• Consider if a unique identifier should be required to access a digital
backup solution
Digital Back-Up Use Case and Design Considerations
5a
87

eLabels Back-up: Non-Digital
Potential non-digital
backup options
Email/mail
information to actor
Call the actor
Use case describes the process of actors proactively contacting an
external actor
• External actor needs to receive a notification to provide non-digital back-up
Non-Digital Back-Up Use Case and Design Considerations
5b
88

Device fails to detect eLabel’s unique
identifier
• Consider responses that company can
take to mitigate a situation where the
actor’s device fails to detect an eLabel’s
unique identifier
Invalid information is populated
• Consider notification options if actor
entered something in error so he/she
can go back to input data
Exception Flow Use Cases and Design
Considerations
Potential Responses
Notification
message
Emergency
contact
information
Re-scan
unique
identifier
i
5c
eLabels Back-up: Exception Flows
89

eLabels Wireframe
Viewing the TransCelerate eLabels Wireframe
The TransCelerate eLabels wireframe demonstrates:
1. Use cases for a foundational eLabel described in this toolkit
2. A few possible enhancements
The wireframe can be viewed through a video in this location
Foundational eLabels………………………..to enhanced
90

Glossary of Terms (1 of 3)
8 Glossary
Term Definition
Alt. Flow (Alternate
Flow
Given a condition, an alternate flow deviates from the Basic Flow but the actor achieves the
use case post-condition.
Auxiliary or “Aux”
Label
Supplemental label that augments or changes the original label content (e.g., expiry update,
country-specific regulatory change, investigator address label, etc.).
Basic Flow Primary flow where the actor fulfills the use case.
Enhanced eLabel
Provides additional information above what is required by regulations or delivers the
information in dynamic or augmented fashion versus a printed label.
eLabel
Provision of a full label on an electronic device with some type of paper label on the product.
Integrated local regulatory and study specific requirements are provided via electronic media
at the time of dispensation of medication to the patient via Mobile/Smart Phone, PC, Tablet PC
or other devices.
Exception Flow Given a condition, an exception flow deviates from the Basic Flow but the actor does not
achieve the use case post-condition.
Foundational eLabel
Transmitting information that is currently on paper labels electronically in a human readable
format.
Initiating Actor
An initiating actor is either a person or an application that directly interacts with the system. In
general an initiating actor is any person, system, or event that inputs data into or receives data
from the application.
92

8 Glossary
Term Definition
IMP Investigational Medicinal Product
JIT (Just in Time)
Labeling
Local regulatory, country and study specific requirements are printed on a label, per shipping
request and then applied to the final pre-assembled kit prior to shipment.
Multi-Level Kit A patient kit that has one or more single level packages.
On-demand Labeling
Local regulatory and study specific requirements are printed on a label, on demand, at point of
assembly and applied to create a unique kit.
Pictogram
A graphic symbol that conveys its meaning through its pictorial resemblance. It can also be
defined as a picture that explains with or without words an instruction.
Process Map A method of visually documenting the steps involved in performing certain stakeholder needs.
93

8 Glossary
Term Definition
Real-time A quantification of the time it takes for a change in data to be reflected.
Single Level Unit/Kit
or Pack
Primary Pack = Patient Kit e.g. a bottle with tablets
Primary pack attached to a secondary pack which makes kit one unit.
Stakeholder
A person, group or organization that has interest or concern about the eLabel initiative
outcomes.
Stakeholder Need
Objectives that eLabels should strive to achieve to satisfy the interest or concern of
stakeholders.
Universal Printed
Label
Paper label that contains limited, language independent information e.g. numbers and
pictograms, and directs to an electronic label.
Use Cases A use case describes a sequence of actions the application performs for the initiating actors.
Wireframe
An image or set of images which displays the functional elements of a website or software
system, typically used for planning structure and functionality.
94

eLabels Initiative - eLabels Toolkit v2.0

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