Selecting the right electronic consent (eConsent) solution is crucial for ensuring compliance, participant comprehension, and efficient management of the informed consent process in clinical trials. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have stringent guidelines and regulations that eConsent solutions must meet to ensure the integrity, security, and accessibility of the informed consent process.

This comprehensive checklist is designed to guide clinical trial sponsors, CROs, and other stakeholders in evaluating eConsent solutions. The checklist aligns each requirement with relevant FDA and EMA regulations, ensuring that the chosen solution not only meets operational needs but also adheres to regulatory standards. By following this checklist, you can make an informed decision that enhances participant experience, maintains data integrity, and ensures regulatory compliance.

1. Media Support

• Video Capability
  • Requirement: Can the system support video content, allowing for the inclusion of visual aids and dynamic explanations of the trial’s purpose, procedures, risks, and benefits?
  • Alignment: FDA and EMA guidelines emphasize the importance of clear communication in informed consent. Video content can enhance understanding by providing visual explanations, aligning with FDA’s 21 CFR Part 50 and EMA’s Guideline on Good Clinical Practice (GCP).
• Multimedia Tiered Approach
  • Requirement: Can the system support a multimedia tiered approach for the consent process, where essential information is presented first, with the option for participants to access more detailed information as needed?
  • Alignment: A multimedia tiered approach involves breaking down consent information into multiple levels of detail. The initial tier provides essential elements in a concise main section, ensuring that participants grasp the core aspects of the study quickly. Subsequent tiers offer expanded sections that delve into more detailed information for those who want a deeper understanding. This approach enhances comprehension and retention by allowing participants to absorb information at their own pace, aligning with FDA and EMA guidelines on informed consent documentation, which stress the importance of presenting information in a clear and understandable manner.
• Voiceover Support
  • Requirement: Can the system support voiceovers of consent documents, allowing participants to listen to the consent information instead of reading it?
  • Alignment: Voiceovers cater to participants with reading difficulties or visual impairments, aligning with FDA and EMA mandates for accessible informed consent processes.

2. Configurability

• Study Element Configuration
  • Requirement: Can the system support configuring study elements such as custom recurrence and frequency of visits, and logical branching based on participant responses?
  • Alignment: Customization aligns with the FDA’s 21 CFR Part 11 requirements for electronic records, ensuring that the system can be tailored to specific study protocols.
• Customizable Content
  • Requirement: Is the consent content customizable based on the study requirements, allowing for the inclusion of specific study details and adjustments as the study progresses?
  • Alignment: Customizable content ensures compliance with EMA’s ICH E6 (R2) GCP guidelines, allowing the consent form to be adapted to the specific details of the study.

3. Monitoring and Compliance

• Participant Monitoring
  • Requirement: Can the system support participant viewing management, ensuring all required sections of the consent form are viewed and acknowledged by the participant?
  • Alignment: Ensures compliance with FDA’s and EMA’s requirements for thorough documentation of the informed consent process, including confirmation that all parts of the consent form have been reviewed by the participant.

4. Participant Experience

• Multilingual Support
  • Requirement: Does the system support multiple languages, allowing participants from different linguistic backgrounds to understand the consent information?
  • Alignment: FDA and EMA regulations mandate that consent information must be understandable to participants, requiring support for multiple languages in international trials.
• User-Friendly Interface
  • Requirement: Is the interface user-friendly, intuitive, and accessible for participants of varying ages and technical abilities?
  • Alignment: Ensures that the consent process is accessible to a diverse participant pool, aligning with ethical guidelines for obtaining informed consent.
• Accessibility Features
  • Requirement: Does the system include features to aid participants with disabilities, such as text-to-speech, screen readers, and adjustable text sizes?
  • Alignment: Aligns with FDA and EMA requirements for making the consent process accessible to all participants, including those with disabilities.

5. Data Security and Compliance

• Regulatory Compliance
  • Requirement: Is the system compliant with regulatory requirements such as 21 CFR Part 11, GDPR, HIPAA, and other relevant data protection and electronic records standards?
  • Alignment: Ensures that the eConsent solution meets the stringent electronic record and data protection standards set by FDA, EMA, and other regulatory bodies.
• Data Encryption
  • Requirement: Are data transmitted and stored using robust encryption methods to protect participant confidentiality and integrity?
  • Alignment: Compliance with data protection regulations such as GDPR and HIPAA is critical, ensuring participant data is secure.
• Audit Trails
  • Requirement: Does the system maintain comprehensive audit trails for consent activities, providing a detailed log of all actions and changes?
  • Alignment: FDA’s 21 CFR Part 11 and EMA’s GCP guidelines require robust audit trails to ensure the integrity and traceability of electronic records.

6. Integration and Compatibility

• Integration with EDC Systems
  • Requirement: Can the eConsent solution integrate seamlessly with Electronic Data Capture (EDC) systems, ensuring a unified data management approach?
  • Alignment: Integration with EDC systems is essential for maintaining a unified electronic record system as required by FDA and EMA.
• Compatibility with Devices
  • Requirement: Is the solution compatible with various devices, including desktops, tablets, and smartphones, ensuring participants can access the consent process on their preferred device?
  • Alignment: Device compatibility ensures that participants can access the consent process regardless of their technological resources, aligning with regulatory requirements for accessibility.

7. Support and Training

• Technical Support
  • Requirement: Is there available technical support for both participants and administrators, ensuring any issues can be promptly addressed?
  • Alignment: Ensures compliance with regulatory expectations for maintaining the integrity of the informed consent process through reliable support systems.
• Training Programs
  • Requirement: Are there training programs and resources available for study teams and participants, ensuring everyone is adequately prepared to use the eConsent system?
  • Alignment: Training aligns with EMA’s GCP guidelines, ensuring that all stakeholders are well-versed in using the eConsent solution effectively.

8. Data Analytics and Reporting

• Real-Time Analytics
  • Requirement: Does the system provide real-time analytics and reporting capabilities, allowing for continuous monitoring and quick identification of any issues?
  • Alignment: Real-time analytics support ongoing compliance monitoring and timely reporting to regulatory bodies as required by FDA and EMA.
• Participant Progress Tracking
  • Requirement: Can the system track participant progress and completion rates, providing insights into the consent process and participant engagement?
  • Alignment: Tracking participant progress ensures that the informed consent process is thoroughly documented and can be audited as required by regulatory guidelines.

This expanded checklist ensures that the eConsent solution not only meets the operational needs of clinical trials but also adheres to the rigorous standards set by FDA and EMA regulations.