Introduction to econsent for Sites

Transcription

1 Introduction to econsent for Sites Last Updated on May 19, 2017

2 General considerations for use General Considerations: The contents of this document were developed as a result of outputs of an econsent site advocacy group (SAG) TransCelerate commissioned through the Society for Clinical Research Sites (SCRS). The purpose of this document is to provide a brief overview of econsent and describe some of the practical aspects that a site might consider when implementing econsent. As described in TransCelerate s econsent Implementation Guidance, sponsor companies can use this presentation to support early and on-going engagement with sites. There are certain slides for which sponsor companies will need to develop customized content. These slides are highlighted by the following icon: Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 2

3 Table of Contents What is econsent? Who benefits with econsent? What are examples of the multi-media components? What is the process for econsent at Sites? What changes for me? Implementation Considerations ICF Process and Document Management Training econsent Submission and Approval System Capability and IT Support Better Practices for Patient Engagement Introducing the econsent Tool to Patients Using the tool to improve patient understanding Where can I get more information? Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 3

4 What is econsent? Pictures Diagrams Video/Audio ICF (e.g., tiered consent) Comment Box/Flags Digital Patient Engagement Digital Signature Dictionary/ Glossary Empowers patients to make informed decisions though the use of interactive, multi-media components Call out boxes Reports, Data/Time Registration System Integration Knowledge Review Enables the improved quality and efficiency of clinical trials through insight into the patient experience, improved data quality, and a fully electronic system. econsent is a tool which can improve the site staff/patient discussion *The term patient refers to study participants, trial participants, subjects Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 4

5 Who benefits with econsent? Patient-Focused Benefits Health Authorities/Ethics Committees Patients Easy to understand Simplified and consistent Engaging and interactive No pressure/ at own pace Tailored to personal learning style Improved version control Improved protection of patients Ability to focus on patient s targeted questions and areas of concern Sites Fewer inspection findings Increased transparency Less paper, less quality risk Sponsors/CROs Timely insight into consentrelated activities Continuous improvement of consent Improved efficiencies Improved ongoing oversight of regulatory compliance Potentially improved patient retention & compliance Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 5

6 Sites Patients What are examples of multi-media components? This section will need to be customized by the sponsor using the tool, but general elements could include: VIDEO Visual and auditory overview of information included in the ICF KNOWLEDGE REVIEW Highlights key information/ concepts. COMMENT BOX Highlight areas and add notes where they have questions or concerns GLOSSARY Provides definitions for unfamiliar words and phrases Sites have access to much more patient data compared to traditional consent to support the site/patient discussion Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 6

7 What is the process for econsent at sites? This activity has been outlined based on pilots conducted in the certain countries in EU, US, Canada, and Australia, with potential for global use Site logs into application using password Key Takeaways: Overall process flow remains very similar to paper consenting process Site verifies patient identity and provides device with appropriate instructions Patient and site have discussion and review any questions Patient and site sign the document econsent does not remove the interaction between site personnel and patient The paper document can always be used when the patient does not want to use econsent. Patient reviews econsent at his/her own pace Patient leaves with print out of informed consent or can be provided with electronic access Site owns the consenting process econsent should be utilized to improve the consenting discussion Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 7

8 What changes for me? What Stays the Same? What Changes? Process mostly stays the same The ICF will still be provided to the patient Patient will still review ICF with as much time as they need Site will still be responsible for ensuring patient has an understanding of the content Both patient and designated site staff will sign the ICF Information will be presented on a digital device including multimedia econsent may change where a patient is provided the ICF Access to Wi-Fi If video is being used may need access to headphones or a private location for privacy Automatic Version Control Re-consenting control Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 8

9 Implementation Considerations This section will need to be customized by the sponsor using the tool, but general elements could include ICF Process and Document Management Training econsent Submission and approval System capability and IT Support Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 9

10 Implementation Considerations: ICF Process and Document Management This section will need to be customized by the sponsor using the tool, but general elements could include: Any Local/Site Specific requirements Site SOP Considerations How will the patients receive their signed copy of the ICF? Site Audits and Inspections Site Archiving Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 10

11 Implementation Considerations: Training This section will need to be customized by the sponsor using the tool, but general elements could include: Who needs to be trained? How and when will the training occur? What type of documentation will the site receive after completion of the training? Will the sponsor accept previously completed econsent training? Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 11

12 Implementation Considerations: System Capability/IT Support and Device Management This section will need to be customized by the sponsor using the tool, but general elements could include: Who will provide the device and where will it come from? Printing from device Device Storage and Security Help Desk Awareness and Details Internet Connection Access and Availability Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 12

13 Implementation Considerations: econsent Submission and Approval This section will need to be customized by the sponsor using the tool, but general elements could include : Insert sponsor specific requirements and considerations for the approval of econsent If site/study is using a central IRB/IEC, it may be beneficial to include information specific to that submission process Regional needs/requirements Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 13

14 Better Practices for Patient Engagement: Introducing econsent to Patients This section will need to be customized by the sponsor using the tool, but general elements could include: 1) Make sure the patient understands the technology and how to navigate it 2) Explain to the patient the content is the same, it is only enhanced by multimedia tools 3) Make it clear that the site staff will always be available 4) See if they prefer paper 5) Observe how patients are interacting with the econsent tool (where are they fumbling, where are they asking questions) Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 14

15 Better Practices for Patient Engagement: Using the tool to improve patient understanding This section will need to be customized by the sponsor using the tool, but general elements could include: Key Messages to include: econsent does not replace the site/patient discussion Patients may highlight specific questions that they have about the content Data coming out of econsent should enhance the discussion Knowledge review, comments/questions Observe if the patient had questions while reviewing Ask if they have any additional questions Time spent per section may not be a direct indicator for comprehension Communicate with the sponsor about the patient experience with econsent this will inform how the tool evolves and also how content can be improved (e.g., continuous improvement) Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 15

16 Where can I get more information? TransCelerate econsent Website FDA econsent Guidelines CTTI Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 16