eLabels Toolkit v2 - Transcelerate€¦ · eLabels Toolkit v2.0 11 December, 2017 Disclaimer: The...

eLabels Toolkit v2.0 11 December, 2017Disclaimer: 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 Concepts4a. eLabels Overview4b. Universal Printed Label4c. Documenting eLabels Processes and Illustrative Cycle Time Improvement4d. eLabels Risk Assessment

5. eLabels Health Authority Landscape

6. eLabels from the Site and Patient Perspective6a. Overview6b. Insights from Investigative Sites6c. Insights from Patients

7. eLabels Technology Approach6a. Technology Landscape Assessment6b. eLabels Technical Architecture6c. eLabels Use Cases and Example of an eLabel

8. Appendices

Introduction

01

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

Key eLabels

Concepts

02


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 FunctionalitiesSample Modular Design Component

Foundation

Information currently

on paper labels electronically

Enhance

Information

content and delivery

Add Functionality

# Description

1Simple and immediate information access for users of the system at the site, home, or

other clinical settingX

2Accessible via portable devices, web computers, etc. (existing means for accessing

information)X

3User Interface with accessibility tools (font size, colors, etc.) and country-required

languagesX

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

7Ability to electronically verify the correct investigational product is given to the correct

patient in the correct clinical trialX X

8Improved 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 FunctionalitiesSample Modular Design Component

FoundationInformation 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

12Enhanced connectivity to enable communication between the patient/site and sponsor and

provide access to information X X

13Ability to link to learning modules and other relevant Clinical Trial tools (e.g., ePRO and

eConsent)X X

14Late stage and/or study-specific customization allows for shared/pooled supplies across trials,

sites, and/or countriesX

15Sensor features in the eLabel for temperature, motion, container opening, product use, etc. to

facilitate monitoring of storage conditions and patient complianceX

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

18Robust 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 DescriptionPatients & 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 country regulations & 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” labelneeded?

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




17.0Is *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 28.0Patient 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

33.0Destroyed 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 Concepts

04


eLabels in Conjunction with a Universal Printed Label* Is An Efficient Alternative to

Conventional Clinical Labeling

Bo

ok

let

Lab

el

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.com184736903


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 Universal Printed Label

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 country regulations & phrase translations

No

4.0 Librarian updates Label System with country regulations & 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


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)



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

21.0Patient 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

29.0Destroyed 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

Se

qu

en

tia

l

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 2-15Week

<1

Design Universal Printed Label

and print

Pa

ralle

l

*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

Universal Printed Label




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.

9System 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

LikelihoodInsignificant

1Minor

2Moderate

3Major

4Catastrophic

5

Almost Certain5

5 10 15 20 25

Likely4

4 8 12 16 20

Possible3

3 6 9 12 15

Unlikely2

2 4 6 8 10

Rare1

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

XTechnology

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 from Patients


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”

• “0 morning, 2 noon & 1 evening capsules”

• “0 morning, 0 noon & 0 evening

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

http://www.aarp.org/research/topics/technology/info-2016/2016-technology-trends-older-americans.html

http://www.pewinternet.org/fact-sheet/internet-broadband/

http://www.acma.gov.au/theACMA/engage-blogs/engage-blogs/Research-snapshots/Digital-lives-of-older-Australians

https://www.ons.gov.uk/businessindustryandtrade/itandinternetindustry/bulletins/internetusers/2017


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 patienta. 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 stepso 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 featuresSTEP 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

ALLEnglish

only

ALLStatic

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 labelNew 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

ProductivityFlexibility 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

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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

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eLabels is an integrated component within the Study Conduct

Business Process


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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**


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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.


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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

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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.


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eLabels Back-up: Digital

Use case describes the process of actors viewing digital

eLabel information on their secondary digital device

Points for consideration:• 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

contactinformation

Re-scan

uniqueidentifier

i

5c


eLabels Back-up: Exception Flows

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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


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https://youtu.be/flJKohKpg0o

Appendices

08


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 eLabelProvides 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 eLabelTransmitting information that is currently on paper labels electronically in a human readable

format.

Initiating ActorAn 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.

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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 LabelingLocal regulatory and study specific requirements are printed on a label, on demand, at point of

assembly and applied to create a unique kit.

PictogramA 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.

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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.

StakeholderA person, group or organization that has interest or concern about the eLabel initiative

outcomes.

Stakeholder NeedObjectives 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.

WireframeAn image or set of images which displays the functional elements of a website or software

system, typically used for planning structure and functionality.

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