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.
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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.
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.
▪ 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
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
Sample eLabels Modular Design Functionalities (1 of 2)Companies must make independent decisions on which eLabels design elements they wish to implement.
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
Conventional Clinical Labeling Label Process Map (1 of 2)
* Representative, High-Level, Multi-country booklet, using IVR/IRT
16
3 Conventional Clinical Labeling
*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
Conventional Clinical Labeling Label Process Map (2 of 2)
* Representative, High-Level, Multi-country booklet, using IVR/IRT
17
Distribution
Site
Patient
3 Conventional Clinical Labeling
*Notes: For simplification, steps and swim lanes may be combined or omitted. Map is intended to depict a representative conventional state across companies.
16.0 Distribution receives Kits (See Process Map 1 of 2)
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
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
*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
Clinical Labeling eLabel Process Map (1 of 2)
* Representative, High-Level, Multi-country booklet, using IVR/IRT
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
*Notes: For simplification, steps and swim lanes may be combined or omitted. Map is intended to depict a representative conventional state across companies.
4c Documenting eLabel Processes
Clinical Labeling eLabel Process Map (2 of 2)
* Representative, High-Level, Multi-country booklet, using IVR/IRT
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
21.0Patient 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
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.
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)
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
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
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 ?
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
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