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Electronic Consent:Obtaining & Documenting Informed

Consent When the Patient is Not in the Room

Melanie Morris Associate Director,

Decentralized Clinical Trials

Industry Shifts & The Evolution of Data

Defining eConsent and Suitability

Requirements and Best Practices

The Patient Experience and Impact to Current Processes

Agenda

Overcoming Adoption Barriers

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Question and Answer Period

Industry Shifts

31

PAPER CRF EDC

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100% SDV/SDR RISK-BASED MONITORING

TRADITIONAL TRIALS DECENTRALIZED TRIALS

The Evolution of Clinical Research Data

Greater

availability of

digital

patient data

Paper-based

CRF

1990 2000 2010 2020

Early adoption of

EDC

EDC

Maturity

Medical

Grade Devices

eSource

Virtual

trials

Consumer Grade

Devices

Mobile

apps

EHR

ePRO

Da

ta-D

rive

n R

ese

arc

h In

sig

hts

• Point data source

• Rise of data digitization

• Lack of connectivity

• Digital data revolution

• Cloud connectivity

• Orchestration of

multimodal digital patient

data

eConsent

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MORE CONFIRMED

DECENTRALIZED TRIALS

STARTED IN JUNE 2020

THAN ANY OTHER MONTH

ON RECORDDecentralized Clinical Trials in 2020:

A Global Survey

PharmaIntelligence Informa

eConsent Defined

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THEDIGITIZATION

OF THECONSENTING

PROCESS

A DYNAMIC

AND

CONFIGURABLE

MULTI-MEDIA

SOLUTION

ENABLES

SHIFT OF TRIAL

ACTIVITIES

INTO THE HOME

eConsent Multimedia Components

6

SIGNATURE INTEGRATION

DocuSign, Adobe Sign, Free-form signatures

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KNOWLEDGE CHECKS

Provide knowledge checks to patients to ensure

understanding and identify gaps for discussion

VIDEO/ AUDIO CONTENT

Integrate video training and audio

recording into the app

DOWNLOADABLE ICF

Store and log any sessions recorded

in a secure environment

SUMMARY BOXES

Providing section highlights

ABC

LANGUAGE OPTIONS

Select language of preference for audio

content

Benefits

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Sponsor/CRO

Site

Patient

► Decreased inspection findings due to improved version control

► Improved oversight via immediate notification of signed consent

► Timely monitoring of informed consent data

► Reduced CRA time on site

► Facilitates version tracking leading to fewer inspection findings

► Ensures consistent messaging to all participants

► Reduced administrative burden

► Self paced learning

► Ability to complete remotely

► Family, caregiver, LAR involvement in consent review

► Informed of updated information in timely manner

The eConsent Continuum

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TRADITIONAL HYBRID FULLY DECENTRALIZED

+ ++

Protocol

Suitability & Risk

Assessment

Subject Suitability

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Pediatric

Rare Disease

Visually Impaired

Language and presentation must

be understandable to a child

Reduced need for long distance

travel and patient inconvenience

Patient should have the choice

of paper based or eConsent

Regulatory RequirementsModality Changes, Requirements Do Not:

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Ensure protection of the rights, safety,

and welfare of

human subjects

Facilitate the subject’s comprehension of

the information

presented during the

eConsent process

Ensure that appropriate

documentation

of consent is obtained

when electronic systems

and processes that may

employ multiple

electronic media are

used to obtain

informed consent

Ensure the quality and

integrity of eConsent

data included in FDA

applications and made

available to FDA during

inspections

21 CRF Compliant

Restricted Access

Secure

Capture Date of Signature

Patient &

Investigator Team

VIRTUAL

PRE-SCREENING

& ASSESSMENTS

ECONSENT

& EASSENT

MEDICATION

ADHERENCE &

REMINDERS

ENGAGEMENT

EPRO /

ECOA /

EDIARY

REIMBURSEMENT

TELEMEDICINE

TRANSPORTATION

MOBILE NURSING

APPLICATIONS

MEDICAL DEVICE

INTEGRATION

GAMIFICATION

& REWARDS

INVESTIGATOR

ALERTS

Technology Platform Requirements

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Presenting eConsent to ParticipantsOHRP and FDA, eIC Must:

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Contain all elements required by FDA regulations

1 Be easy to navigate2 Use appropriate electronic strategies3

Provide copy to patient65 Permit questions and understanding checks4 Permit adequate time

eConsent Administration

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SUPPORT PATIENT ENGAGEMENT PROCESSES

Support the consenting process and discussion, ensure

understanding

SCREEN SHARING

Allow the clinician to share any documents for discussion

LIVE DISCUSSION/INSTANT MESSAGING

Use other methods of communication for preference

TEAM CALLING

Support sessions that include the patient, caregivers, LAR

and clinicians

SUPPORT TECHNOLOGY NAVIGATION

Support patients with technology navigation as required

Impact to Study Start-Up

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Process Flow

Decision to use

eConsent

Standard

process ICF

development

Site and Patient

training

Device

provisioning

eConsent

release to

Platform

EC submission/

approval

Materials

provided for EC

submission

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PATIENT

IDENTIFIED

FOR STUDY

CONSENT

DISCUSSION

PATIENT AND PI

PATIENT

SIGNS

CONSENT

PATIENT RECEIVES

eCOPY OF SIGNED

CONSENT

PATIENT DOWNLOAD

APP/ REVIEWS

CONSENT

PI SIGNS

CONSENT

PATIENT-DIRECTED

PI CONSENT

DISCUSSION

The Patient Experience: Remote

PI VERIFIES

PATIENT ID VIA

TELEVISIT

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1

2

3

4

5

6

PATIENT

IDENTIFIED

FOR STUDY

PATIENT

REVIEWS

CONSENT

WITHIN

PATIENT APP

PATIENT AND

PI CONSENT

DISCUSSION

PATIENT

SIGNS

CONSENT

PI SIGNS

CONSENT

PATIENT

RECEIVES

COPY OF

SIGNED

CONSENT

The Patient Experience: Onsite

Centralized Monitoring of eConsent

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CRA logs into platform1Verifies that the approved versionof the consent is available

2Verifies approved versionused for each participant

3

Reviews source documents pertaining to consent

4 Verifies against EDC data5Review/collects regulatory documentation

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Overcoming Adoption Barriers

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Demonstrate success to ease concerns

Gather participant feedback

Build awareness around unchanged requirements

and similarities to paper-based process

Further regulatory guidance will ease concerns

Key Messages

eConsent enhances the patient experience

A change in how consent is administered, not process

Fundamental principles and requirements do not change

Protocol and Subject Suitability must be assessed

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Paper ICF

• Complex language

• Long forms

Electronic Consent

• User-friendly navigation and content

• Review at patients own pace

• Integrated tools

• Targeted discussions

• Improved version control

References

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•eConsent: Implementation Guidance (eConsent Initiative).

Transcelerate BioPharma Inc.

https://www.transceleratebiopharmainc.com/wp-content/uploads/2017/10/eConsent-

Implementation-Guidance.pdf

•Decentralized Clinical Trials in 2020: A Global Survey

•PharmaIntelligence Informa

•Use of Electronic Informed Consent: Questions and Answers:

Guidance for Institutional Review Boards, Investigators, and Sponsors

•Office for Human Research Protections, Food and Drug Administration

•https://www.fda.gov/media/116850/download

https://www.transceleratebiopharmainc.com/wp-content/uploads/2017/10/eConsent-Implementation-Guidance.pdfhttps://www.fda.gov/media/116850/download

Question & Answer

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