2018: eConsent Country Overview
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 2
We advise
users to be
cautious in their
interpretation
and use of the
data. Consider
the following:
eConsent Landscape Assessment:
Overview
The intention of the eConsent Landscape Assessment is to share the
collected, aggregated, and blinded survey data on global experience
with eConsent. The survey was sent to pharmaceutical companies,
clinical research organizations (CROs), and eConsent vendors in
December 2016 and updated in March 2018.
Due to the anonymized approach for data aggregation, there
could potentially be duplicate data from the same submission/pilot.
• For example, a pharmaceutical company and eConsent vendor could
report on the same submission.
A lack of precedent of an operational or multi-media component in
a given country does not imply that it CANNOT be used.
• For example, the lack of use of electronic signature in a given country may
be due to business decisions, rather than due to regulatory considerations.
The information provided does not supersede any local regulation.
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 3
eConsent Landscape Assessment:
Data Presentation
The Data is presented in 3 levels:
1. Global LevelGlobal view which shows where survey respondents have submitted eConsent and used eConsent to consent patients.
Note: Additional data included for the use of eConsent with vulnerable populations and reasons for removal of a country from planned eConsent strategy.
2. Country LevelCountry-specific information which highlights the multi-media components, operational considerations, signature types, and HA and IRB submission materials used. Details on HA and IRB feedback are also included.
3. Detailed LevelThe blinded and aggregated results from the survey are provided in detail in an excel sheet.
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 4
eConsent Landscape Assessment:
Stakeholder Response Breakdown
There were a total
of 17 responses to
the 2016
eConsent
Landscape
Survey and 3
responses to the 2018 Survey as
updates to
previous
responses.
11
3 2 10
2
4
6
8
10
12
Sponsor
Company
eConsent
Vendor
CRO Other*
Stakeholder Perspective
*Note: 1 response was submitted by a self-identified patient. The response answers are not included in the summary report or detailed report.
Global Level
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 6
eConsent Around the World 2016-2018eConsent used to consent patientseConsent submissions
The following data were collected in December 2016 from 16 responses* to the TransCelerate eConsent
Landscape survey and in March 2018 from 3 responses as updates to those provided in 2016. In total, according
to the survey results, 33 countries have had eConsent submissions (to HAs and/or IRB/IECs), of which 17 have
actively consented patients using eConsent.
* Dec 2016 Survey: Originally there were 17 responses. 1 response was submitted by a self-identified patient and is not included in the summary report or detailed report.
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 7
2016-2018 Global eConsent
Submissions and Patients Consented
The following data were collected in December 2016 from 16 responses* and in March 2018 from 3 responses
as updates to those provided in 2016 to the TransCelerate eConsent Landscape survey.
Countries with eConsent
submissions: 33
Countries where patients were consented via
eConsent: 17
*1 response was submitted by a self-identified patient. The responses are not included in the summary report or detailed report.
CountryeConsent
Submissions
Patients
Consented
w/eConsent
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Denmark
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
CountryeConsent
Submissions
Patients
Consented
w/eConsent
Japan
Korea, Republic of
Mexico
Netherlands
New Zealand
Norway
Poland
Puerto Rico
Romania
Saudi Arabia
South Africa
Spain
Sweden
Taiwan
Turkey
UK
USA
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 8
Reasons for Removal of Country from
eConsent Strategy
In total, 5 responses out of 16 were received for reasons that a country*
was removed from the original scope of an eConsent pilot
Total Responses Additional information provided
2Health Authority/
IRB Feedback
• “USA: One IRB did refuse eConsent as the site were already piloting
for another sponsor.”
• “Some countries will not allow eConsent to be utilized at all.”
3 Other
• “We tried in Japan. In Japan would do eSource but the PIs wanted to
use paper ICFs at the last minute.”
• “Site did not accept eConsent”
• “Resistance to acceptance of eSignature, or lack of commitment to
accept eSignature”
*Note: In this survey, we did not collect information regarding which countries were specifically removed.
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 9
Vulnerable Populations Included in
eConsent Study
4 Free Text Responses
“Deployed for pediatric and rare disease populations, no special considerations other than to reframe
some of the pediatric content to be age appropriate for educational purposes.”
“Illiterate patients in India”
“One of the pilot studies included a population with visual impairment. For this population, we included a
zoom in/zoom out feature to enlarge the font size, we also provided sites with large monitors so the
patients could view the eICF more easily; this may be a consideration for use of eICF in other visually
impaired populations.”
“One of the studies was in a population of rheumatoid arthritis patients, we provided a stylus as an option
to interact with the iPad”
In total, 4 responses out of 16 were received for respondents who included
vulnerable populations* in their study. Their free response details are
included below.
*Vulnerable population is defined as a subset of the community that may have additional considerations
impacting their ability to make a voluntary and informed decision (e.g., children, physically/visually impaired)
Country
Specific Level
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 11
How to Use the Country-Specific Information
Country Name & Flag
Response Breakdown: Of the 16* total survey responders, the number that submitted for eConsent and consented patients using eConsent in this country.
Multi-Media Components: The multi-media
components included in the total submission documents
and/or used to consent patients in this country will be
highlighted in green, those not indicated in the survey
responses will be greyed out. Signature Types: Check marks will indicate the signature types used for sites and patients from this country.
Submission Documents:Check marks will indicate the type of document submitted to HAs and IRB/IEC for this country.Feedback Received:
Any free text responses captured via the survey for feedback received from HA, IRB/IECs, and
other official reviewers for submission documents to this country.
Operational
Considerations/ Issues: The operational
considerations and issues included in the total
submission documents and/or used to consent
patients in this country will be highlighted in blue, those not
indicated in the survey responses will be greyed out.
Other*The asterisk designates fields that have additional data in the Excel spreadsheet containing the blinded and aggregated survey results.
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 12
Description of Multi-media Components
Media Type Description
Tiered ConsentConsent form that front loads all essential elements into a concise opening section, and assigns more-detailed, information to later sections
Video Visual and auditory overview of information included in the ICF
Audio Auditory overview of information included in the ICF
Pictures/Diagrams Visual that help to explain and reinforce key trial components or complex topics
Summary BoxesUsed to highlight and reinforce key ideas in 1 or 2 simple sentences within the consent content section
Knowledge Review Highlights key information/ concepts
Dictionary/Glossary Provides definitions for unfamiliar words and phrases
Content FlagsMark or flag content or specific words/sentences where a study participant would like to ask a question to ensure his/her clarity and comprehension, or to simply indicate that a question exists regarding the specific text
Section-based Subject Attestation
Per section confirmation of patient understanding
Patient Comment Box
Highlight areas and add notes where the patient has questions or concerns
Site Comment Box Free text fields to record all documentation regarding the informed consent process
Other* Additional details can be found in detailed view.
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 13
Description of Operational Considerations/Issues
Patient received paper copy
after consentingAfter the patient consents using
eConsent, the paper copy is provided
to the patient.
Patient received electronic
copy after consentingAfter the patient consents using
eConsent, an electronic version is
provided to the patient.
Consent Components
Available for Home UseMulti-media components (e.g., video,
audio) from the eConsent are
available on the patient’s own device
outside of the site.
Collected Patient NameThe name of the patient is a captured
field for the eConsent form.
Site-Provisioned DeviceeConsent is delivered on site-owned
device
Bring Your Own Device
(Patient-Provided)eConsent is delivered on patient
owned device
Remote ConsentingConsent process conducted outside
of site. Additional details can be found
in detailed view.
Date/Time RegistrationDate and time stamp captured at the
start of consent, for each section of
the consent, and/or completion of the
consent form.
Other Operational
Consideration“Other” choice selected in survey.
Additional details can be found in
detailed view.
Issues Importing DevicesAdditional consideration was taken
while importing or planning to import
devices into the specific country
Remote MonitoringMonitoring on the trial and the
consent process is done remotely.
On-Site MonitoringMonitoring on the trial and the
consent process is completed on site.
Central MonitoringMonitoring on the trial and consent
process is completed at a centralized
location.
Other MonitoringOther form of monitoring the trial and
consent process. Additional details
can be found in detailed view.
Collected Patient MetadataPatient experience descriptors,
including but not limited to time spent
on a specific section, the number of
words marked unfamiliar, the number
of correct/incorrect knowledge
checks.
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 14
Argentina2 Total Responses
2 eConsent Submissions
0eConsent used to Consent Patients
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓
Feedback Received
HA • No feedback and submission approved
IRB/IEC • No feedback and submission approved
Other • N/A
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
SummaryBoxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 15
Australia 3 Total Responses
3 eConsent Submissions
0eConsent used to Consent Patients
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓
Feedback Received
HA • No feedback and submission approved
IRB/IEC • No feedback and submission approved
Other • N/A
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
SummaryBoxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature ✓ ✓
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 16
Austria
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
SummaryBoxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 17
Belgium
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 18
Brazil
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓
Feedback Received
HA • No feedback and submission approved
IRB/IEC • No feedback and submission approved
Other • N/A
2 Total Responses
2 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature ✓ ✓
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 19
Canada5 Total Responses
5 eConsent Submissions
2eConsent used to Consent Patients
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓ ✓
Link to Portal ✓
PDF/Word Consent Content ✓ ✓
Link to Video/Video Script (New 2018) ✓ ✓
No Additional Submission Documents ✓
Other* ✓ ✓
Feedback Received
HA• Due to study design, Health Canada will only be involved in
the second phase and wants to receive a report on the first
phase before they grant approval
IRB/IEC• Submissions occurred, but approval will only be given after
the Health Canada "No Objection letter"" is received
Other• One ethics committee wanted the details of the patient
name to be removed
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature ✓ ✓
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other* ✓ ✓
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 20
China
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 21
Denmark
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots
Link to Portal
PDF/Word Consent Content
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other*
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 22
Finland
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • No feedback
Other • N/A
1 Total Responses
1 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature
Qualified Certificate
On Paper
On Paper and Uploaded into System
Other* ✓ ✓
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 23
France
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓ ✓
Link to Portal ✓ ✓
PDF/Word Consent Content ✓ ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓ ✓
Feedback Received
HA • No feedback and submission approved
IRB/IEC • No feedback and submission approved
Other • N/A
4 Total Responses
4 eConsent Submissions
3eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature ✓ ✓
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System ✓ ✓
Other* ✓ ✓
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 24
Germany
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓
Feedback Received
HA • No feedback
IRB/IEC• Requested to make it clear in the information and IC
that in any case for study participation the written IC including the hand-written date are decisive
Other • N/A
2 Total Responses
2 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other* ✓ ✓
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 25
Greece
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 26
Hungary
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓ ✓
Link to Portal
PDF/Word Consent Content ✓ ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓ ✓
Feedback Received
HA • No feedback and submission approved
IRB/IEC • No feedback and submission approved
Other • N/A
2 Total Responses
2 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary
Boxes
Knowledge
Review
Dictionary/
Glossary
Content Box/
Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 27
India
Submission Documents Submitted HA IRB/ IEC
Patient Facing Screen Shots ✓ ✓
Link to Portal
PDF/Word Consent Content ✓ ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓ ✓
Feedback Received
HA
• Requested changes to video and audio content (additional
specific language added to video voiceover)
• Expressed interest in expanded multimedia content
• Told to collect either electronic or paper signature, not both,
as both would be a burden to the patient
IRB/IEC • General Positive/Supportive Feedback
Other • N/A
2 Total Responses
2 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 28
Israel
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 29
Italy
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 30
Japan
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓ ✓
Link to Portal
PDF/Word Consent Content ✓ ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • Feedback regarding site
IRB/IEC • No feedback
Other • N/A
2 Total Responses
2 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other* ✓ ✓
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 31
Korea, Republic of
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal ✓
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018) ✓
No Additional Submission Documents
Other* ✓ ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • Study recruitment ended before approval
2 Total Responses
2 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 32
Mexico
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓
Feedback Received
HA • No feedback and submission approved
IRB/IEC • No feedback and submission approved
Other • N/A
2 Total Responses
2 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 33
Netherlands
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 34
New Zealand
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other*
Feedback Received
HA • No feedback and submission approved
IRB/IEC • No feedback and submission approved
Other • N/A
2 Total Responses
2 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 35
Norway
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓ ✓
Link to Portal ✓ ✓
PDF/Word Consent Content ✓ ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓ ✓
Feedback Received
HA • No feedback and submission approved
IRB/IEC • No feedback and submission approved
Other• Additional required document review by data
privacy committee
1 Total Responses
1 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature
Qualified Certificate
On Paper
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 36
Poland
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based
Subject Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 37
Puerto Rico
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots
Link to Portal
PDF/Word Consent Content
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other*
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature ✓ ✓
Qualified Certificate
On Paper
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based
Subject Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 38
Romania
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based
Subject Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 39
Saudi Arabia
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other• Additional documentation required by another
official reviewer
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 40
South Africa
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots
Link to Portal
PDF/Word Consent Content
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other*
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 41
Spain
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓
Feedback Received
HA • No feedback and submission was approved
IRB/IEC • No feedback and submission was approved
Other • N/A
2 Total Responses
2 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 42
Sweden
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots
Link to Portal
PDF/Word Consent Content
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other*
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature ✓ ✓
Qualified Certificate
On Paper
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 43
Taiwan
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 44
Turkey
Submission Documents Submitted HAIRB/
IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents
Other* ✓
Feedback Received
HA • N/A
IRB/IEC • N/A
Other • N/A
1 Total Responses
1 eConsent Submissions
0eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature
Advanced Electronic Signature
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based Subject
Attestation
Patient Comment Box
Site Comment Box
Other*
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 45
United Kingdom
Submission Documents Submitted HA IRB/ IEC
Patient Facing Screen Shots ✓
Link to Portal
PDF/Word Consent Content ✓
Link to Video/Video Script (New 2018)
No Additional Submission Documents ✓
Other* ✓
Feedback Received
HA • No feedback and submission approved
IRB/IEC• We had a generic approval of the system with each
individual consent form a number of studies loaded in to the
system
Other• The Vendor had met with the HRA in the UK and had
discussed the use of their eConsent system and had secured
their approval
3 Total Responses
3 eConsent Submissions
1eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature ✓ ✓
Qualified Certificate
On Paper ✓ ✓
On Paper and Uploaded into System
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based
Subject Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 46
United States
Submission Documents Submitted HA IRB/ IEC
Patient Facing Screen Shots ✓ ✓
Link to Portal ✓ ✓
PDF/Word Consent Content ✓ ✓
Link to Video/Video Script (New 2018) ✓
No Additional Submission Documents ✓
Other* ✓ ✓
Feedback Received
HA• No feedback and submission approved
• General Positive/Supportive Feedback
IRB/IEC
• No feedback and submission approved
• General Positive/Supportive Feedback
• IRB wanted boxes next to each item that the subject
was consenting for
Other • N/A
15 Total Responses
15 eConsent Submissions
15eConsent used to Consent Patients
Signature Types Patient Site
Electronic Signature ✓ ✓
Advanced Electronic Signature ✓ ✓
Qualified Certificate ✓ ✓
On Paper ✓ ✓
On Paper and Uploaded into System ✓ ✓
Other*
*Note: Additional details can be found in the Excel spreadsheet containing the blinded and aggregated survey results for fields designated with an asterisk
Multi-Media Components Submitted
ICF (Tiered Consent)
Video Audio Pictures/ Diagram
Summary Boxes
Knowledge Review
Dictionary/ Glossary
Content Box/ Flag
Section Based
Subject Attestation
Patient Comment Box
Site Comment Box
Other*
Operational Considerations/Issues Submitted
Patient Received
Paper Copy After
Consenting
Patient Received Electronic Copy After Consenting
Consent Components Available for
Home Use
Collected Patient Name
Site-Provisioned
Device
Bring Your Own Device
(Patient-Provided)
Remote Consenting*
Date/Time Registration
Other Operational
Consideration*
Issues Importing Devices*
Remote Monitoring
On-Site Monitoring
Central Monitoring
Other Monitoring*
Collected Patient
Metadata (New 2018)
Copyright ©2018 TransCelerate BioPharma Inc., All Rights Reserved. 47
Detailed information
Link to detailed aggregated
information from the survey
Link to the survey questions