The life science industry is keen to leverage electronic means for consenting trial participants but are uncertain of regulatory positions on the topic.

Medidata conducted a study to understand the regulatory positions, adoption and variability regarding electronic informed (eConsent) around the world. The study initially focused on the countries in the European geographic region, where Medidata engaged EU regulatory authorities and industry trade associations on the concerns using eConsent.

PROTECTIONOF PATIENT DATA

01“Will management/oversight fall

under the investigator or the sponsor?”

TRIAL PARTICIPANTVERIFICATION

04“How to ensure that person electronically signing the Informed Consent Form is the actual person participating?”

RESPONSIBILITIES OFTHE INVESTIGATOR

05“How should the investigator

qualify and supervise thirdparties’ personnel and computer system(s)?”

SHARING ELECTRONIC CONSENT DATA

02

“Only anonymized data should be shared with the sponsor.”

REGIONAL &LOCAL DATA

03

“Does European data privacy rules allow athird party to host patients’ signature?”

SITEBURDEN

06“Investigators may not

be keen to adopt such technologies as theyneed to use multiple

systems per trial.”

PRIVACY LAWS

COMMON AUTHORITYCONCERNSFOR eCONSENT

Sponsors are blinded to a patient’s Personally

Identifiable Information(PII), with investigators only

sharing de-identified data

If a solution is proposed to an investigator, it is the

sponsor and third party who need to provide

assurance that the process and technology

are in line with ICH Good Clinical Practice (GCP)

and computer system validation compliance

eConsent provider complies with EU General Data Protection Regulation (GDPR) when it enters a direct data protection agreement with the investigator or where its contract with the sponsor is for the benefit of the investigator. At Medidata, PII is protected by having all electronic records and signatures have audit trails in compliance with FDA and ICH guidelines

The investigating site maintains control of subjects’ PII, and pseudonymized data (information is replaced by artificial identifiers and non-attributable) is shared with the sponsor

eConsent does not have to replace paper-based methods and can be used to assist the investigator to explain details. eConsent can also be done with real time audio or audio-visual methods to verify a participant’s identity

1. Medidata, 2020. White Paper : Electronic Informed Consent in Clinical Research*For more detailed information, please reach out directly to relevant national health or local privacy data protection authorities

Site burden needs to be analyzed in the context of

the patient. Sponsors and CROs should review

their technology footprint to help reduce burden.

Medidata believes the industry should collaborate

to develop more streamlined, simplified,

integrated processes with an end-to-end unification of

technologies

Full eConsent is permitted. So far, the

only example is the UK.

1

The use of electronic methods for informing a

trial participant is permitted, but the

signature, if electronic, has to be a qualified signature. Poland is

an example.

2

The use of electronic methods for informing

a trial participant is permitted, but the

signature has to be a handwritten wet

signature on paper only. Austria is an example.

3

There was either no position and/or the

position was pending EMA and inspector’s

working group guidance.

4

Pending response of acknowledgement.

5

eConsent enables potential research participants to make an informed decision via the convenience of a tablet, smartphone, or other digital multimedia, and it enables their informed consent to be documented using electronic signatures. It can supplement the traditional paper-based approach or, where appropriate, replace it.

Regulatory Considerations On

ELECTRONIC INFORMEDCONSENT IN CLINICAL RESEARCH

1