2018: econsent country overview - transcelerate · country name & flag response breakdown: of...

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.



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.



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


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.


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


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.


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


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.


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.


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.


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


(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*


Australia 3 Total Responses




IEC


Link to Portal




Other* ✓

Feedback Received



Other • N/A





SummaryBoxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)



Advanced Electronic Signature ✓ ✓


On Paper ✓ ✓


Other*


Austria


IEC


Link to Portal



No Additional Submission Documents

Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*





SummaryBoxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Belgium


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Brazil


IEC


Link to Portal




Other* ✓

Feedback Received



Other • N/A

2 Total Responses







On Paper ✓ ✓


Other*





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Canada5 Total Responses




IEC

Patient Facing Screen Shots ✓ ✓

Link to Portal ✓

PDF/Word Consent Content ✓ ✓

Link to Video/Video Script (New 2018) ✓ ✓


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


Electronic Signature ✓ ✓



On Paper ✓ ✓


Other* ✓ ✓





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


China


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Denmark


IEC

Patient Facing Screen Shots

Link to Portal

PDF/Word Consent Content



Other*

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Finland


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • No feedback

Other • N/A

1 Total Responses







On Paper


Other* ✓ ✓



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


France


IEC


Link to Portal ✓ ✓




Other* ✓ ✓

Feedback Received



Other • N/A

4 Total Responses







On Paper ✓ ✓

On Paper and Uploaded into System ✓ ✓

Other* ✓ ✓





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Germany


IEC


Link to Portal




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







On Paper ✓ ✓


Other* ✓ ✓





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Greece


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Hungary


IEC


Link to Portal




Other* ✓ ✓

Feedback Received



Other • N/A

2 Total Responses







On Paper ✓ ✓


Other*





Summary

Boxes

Knowledge

Review

Dictionary/

Glossary

Content Box/

Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


India

Submission Documents Submitted HA IRB/ IEC


Link to Portal




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







On Paper ✓ ✓


Other*





Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Israel


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Italy


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Japan


IEC


Link to Portal




Other* ✓

Feedback Received

HA • Feedback regarding site

IRB/IEC • No feedback

Other • N/A

2 Total Responses







On Paper ✓ ✓


Other* ✓ ✓



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Korea, Republic of


IEC


Link to Portal ✓


Link to Video/Video Script (New 2018) ✓


Other* ✓ ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • Study recruitment ended before approval

2 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Mexico


IEC


Link to Portal




Other* ✓

Feedback Received



Other • N/A

2 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Netherlands


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


New Zealand


IEC


Link to Portal




Other*

Feedback Received



Other • N/A

2 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Norway


IEC






Other* ✓ ✓

Feedback Received



Other• Additional required document review by data

privacy committee

1 Total Responses







On Paper


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Poland


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag

Section Based

Subject Attestation

Patient Comment Box

Site Comment Box

Other*


Puerto Rico


IEC


Link to Portal




Other*

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag

Section Based

Subject Attestation

Patient Comment Box

Site Comment Box

Other*


Romania


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag

Section Based

Subject Attestation

Patient Comment Box

Site Comment Box

Other*


Saudi Arabia


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other• Additional documentation required by another

official reviewer

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


South Africa


IEC


Link to Portal




Other*

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Spain


IEC


Link to Portal




Other* ✓

Feedback Received

HA • No feedback and submission was approved

IRB/IEC • No feedback and submission was approved

Other • N/A

2 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Sweden


IEC


Link to Portal




Other*

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Taiwan


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


Turkey


IEC


Link to Portal




Other* ✓

Feedback Received

HA • N/A

IRB/IEC • N/A

Other • N/A

1 Total Responses







On Paper ✓ ✓


Other*



Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)




Summary Boxes

Knowledge Review


Content Box/ Flag


Attestation

Patient Comment Box

Site Comment Box

Other*


United Kingdom



Link to Portal




Other* ✓

Feedback Received


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







On Paper ✓ ✓


Other*





Summary Boxes

Knowledge Review


Content Box/ Flag

Section Based

Subject Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


United States





Link to Video/Video Script (New 2018) ✓


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






Qualified Certificate ✓ ✓

On Paper ✓ ✓

On Paper and Uploaded into System ✓ ✓

Other*





Summary Boxes

Knowledge Review


Content Box/ Flag

Section Based

Subject Attestation

Patient Comment Box

Site Comment Box

Other*


Patient Received

Paper Copy After

Consenting



Home Use


Site-Provisioned

Device


(Patient-Provided)

Remote Consenting*


Other Operational

Consideration*


Remote Monitoring

On-Site Monitoring

Central Monitoring

Other Monitoring*

Collected Patient

Metadata (New 2018)


Detailed information

Link to detailed aggregated

information from the survey

Link to the survey questions

https://www.transceleratebiopharmainc.com/wp-content/uploads/2019/02/eConsent-Survey-Data-By-Country-2018-Update.xlsx

https://www.transceleratebiopharmainc.com/wp-content/uploads/2019/02/eConsentGlobalExperienceSurvey.pdf