Implementation Guidance

It is helpful to review the following for pilot studies:

1. Study design, duration, and complexity
2. Region(s)/countries(s)
3. Clinical sites
4. Study size and patient population
5. Language

Additional Tools to Consider:

eConsent Considerations for Health Literacy

eConsent Considerations for Vulnerable Populations

Some simple considerations when defining multimedia components include connecting with colleagues who have experience with eConsent to seek advice and to determine if any details have been missed, gathering input from sites and involving team members from various functional areas who will have different ideas about functionalities, uses, etc. It is important to:

• Review study considerations as it will help determine which multimedia components are needed versus nice to have
• Create clear criteria that a potential vendor may use to customize their product demonstration
• Review number and type of multimedia components, particularly if this is the first time this technology is being used within the company

Additional Tools to Consider:

CTTI/WHO Operational Examples of eConsent

One may consider lessons learned from similar technology implementations. Specifically, this is important when contemplating:

• Device management (on-site)
• Re-consenting
• Optional consent
• Withdrawal of consent
• Remote Consent (or home consent)
• Other methods of documenting informed consent (Digital fingerprinting, voice recording or passcode)

As with other technologies, data protection and data transparency are of utmost importance. The following suggestions are key to data privacy and legal compliance:

Data Privacy/Confidentiality

• Consult with the privacy experts/legal department at your company
• Review IT security
• Consider the capabilities/logistics of the vendor with regard to server location, administrator location, access to data, and data storage

Remote Monitoring Considerations

• Build protections against potential issues with breach of confidentiality associated with remote monitoring
• Identify areas of training for remote monitoring and best security practices
• Restrict certain data fields that could identify patient to comply with any applicable local and legal requirements

Considerations for Different eConsent Components

• Consider the impact of access to a knowledge valuation, time spent for the informed consent process, and the potential for inspection findings
• Review requirements/restrictions for components by the regulatory and data privacy agencies
• Understand the need for supplemental information (e.g., additional text including glossary)

Fraud Considerations (Critical for at-home use)

• May include concerns around verification of identity, potential workarounds, and guidance to influence IRBs/HAs
• Consider technology that controls user access and ensures patient/participant identity

Provide clear governance to all internal stakeholders. Below are examples of possible topics to include:

• Review SOPs related to informed consent form to ensure there are no barriers for eConsent use
• Assess company-specific stakeholders and obtain their endorsements
• Clear goals, objectives, roles, responsibilities, guidance, and instructions
• Forum to drive/lead innovation
• Leadership involvement/sponsorship to set a culture for change
• Financial considerations such as initial cost, return on investment, resource impact
• eConsent enterprise-wide/study strategy
• Champion change management
  • Communication planning to minimize internal stakeholder adoption barriers

Consider the following throughout the study to ensure a good working relationship between sponsor and vendor:

• Kickoff Meeting with Vendor
• Governance planning:
  • Communication plan
    • Ensure communication lines are set up; define working relationships
    • Identify the main contact person assigned at the vendor
  • Create an issue escalation plan
  • Create a risk identification and contingency plan
• Changing regulatory environment
  • Work collaboratively between the sponsor and vendor to ensure the project remains on track given the regulatory landscape

All versions of the eConsent should be available during the study and following archiving. This requires the sponsors to decide access requirements by stakeholders and various stages of the clinical study. For example, during the study the sponsor may have access to participant data, but after archival the data is de-identified for the sponsor.

As part of the process sponsors must:

• Vendor Considerations: Discuss the vendor’s policies for storing and archiving approved documents
• Site Considerations: During and after the study the site will have access to eConsent data, although the format of that data may change after archival (e.g., CD-ROM). In addition, some countries permit filing in an electronic system, while others require printed copies of all documents to be available

Critical success factors (CSFs) allow an organization to define and measure the outcomes of an initiative (e.g., what does success look like). Analysis of CSFs should also provide guidance on how to better manage broader eConsent organizational implementation and assist with more efficient and effective ways of executing work, optimizing resources and increasing quality. CSFs for an eConsent pilot and/or scale-up should demonstrate improved patient-centric efforts and enhanced integration of the patient in the overall consent process. It may be useful to consider the following CSFs when planning an eConsent pilot and/or scale-up analysis:

• Audit/inspection reports (e.g., comparative assessment with historical data)
• Quality assessments
• Timing assessment (e.g., study start-up timelines)
• Usage assessment (e.g., participant comprehension/satisfaction, participant engagement)

Develop processes to ensure the sponsor has up-to-date access to information from the vendor and can direct or participate in problem solving if issues arise. Consider the following:

• Provide Guidance for Monitors
• Define Analytic Data Fields
• Establish an eConsent Go-Live Plan
• Develop a Contingency Planning
• Training Strategy for Sites
• Training for sites can take place in a variety of formats, usually one or both of the following: (1) virtual, (2) electronic training upon initial system access or (3) live training on site or during the investigator meeting. The format can be decided at the kickoff meeting

There are fundamental similarities in the objectives of the core activities between the paper ICF and eConsent. Critical to consider:

• Site Processes: Work with sites to determine the site’s capabilities to use eConsent. Create guidelines on how eConsent can be aligned with the normal site procedures. For helpful site facing tools, click here.
• IRB/IEC Processes: Timing of IRB/IEC submissions are essential to a smooth eConsent process. Before submissions, consider the approval timeline, particularly if multiple countries are selected, and the impact this may have on the study timelines.
• Health Authority Processes: Potential interactions with health authorities should be considered in planning, as well as the early involvement of internal regulatory compliance and legal groups. In countries where there is no established precedent for eConsent, consider a discussion with HAs to define the submission package. The elements of the submission will likely depend on whether the country has IRB/IEC review processes in place and the extent of the health authorities current consent review process.
• CRO Processes: When considering using CROs to implement eConsent for a study initial engagement is as important as continued oversight of and collaboration with the CROs. The initial engagement should precisely and clearly define the expectations for eConsent management and development for the study. Determine if the eConsent development process will be led by the CRO or sponsor.

Monitoring is the act of overseeing a clinical study and ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, ICH GCP guidelines, and any applicable local regulatory requirement(s). This can be done on site, remotely, or via centralized monitoring activities as indicated in the monitoring plan.

Below are some example reports that can be used to support oversight, compliance, and study management:

• List of all approved ICF versions with dates of implementation
• List of participant numbers with approved ICF versions
• List of comments by the investigator by subject number
• List of consented participants
• List of re-consented participants

eConsent provides the capability of accessing data remotely and centrally, allowing for real-time eConsent review and analysis and thus quicker identification, resolution and prevention of issues/concerns

The sponsor’s procedures/policies should be followed to ensure proper audit/inspection readiness, including:

• Inspector/auditor access to eConsent (system, document, and reports)
• Contingency plan in case of eConsent system failure (business continuity)

The sponsor’s procedures/policies should be followed to ensure proper management of filing and archiving.