Managing informed consent and other types of consent is a vital component of clinical studies, ensuring compliance with regulations, protecting participant rights, and facilitating clear communication. However, traditional consent processes are time-consuming, cumbersome, and difficult to scale. With the 2024.2 release, AEC introduces enhancements designed to enhance consenting options for clinical studies and address specific regulatory requirements in the UK.
The updates in this release address common challenges faced by medical device manufacturers and clinical teams:
Regulatory Compliance
Global regulatory frameworks like ISO 14155 and regional rules (e.g., explicit consent in the UK) require adaptable and compliant consent processes. Meeting these standards efficiently is essential for trial success.
Improving Participant Engagement and Experience
Today’s clinical trials prioritize participant autonomy and transparency. Features like explicit consent and customizable sign-up workflows help participants make informed decisions and stay engaged.
Streamlining Operational Workflows
Manual consent management can slow study progress and drain resources. Automating consent workflows and digitizing the process reduces administrative burdens while maintaining compliance.
Supporting Diverse Study Needs
From low-risk PMCF studies to complex, multi-country trials, clinical teams need flexible consent tools that adapt to the unique demands of their studies. The 2024.2 release provides the scalability and customization required to meet these challenges.
The New Consent Features: Innovation in Action
Explicit Consent: Enabling Optional Elements
Designed for studies with optional elements, explicit consent lets participants actively engage with consent documents. They can tick checkboxes or select yes/no options before signing electronically, ensuring compliance and participant clarity.
- Designed to be compliant with UK study requirements.
- Fully customizable fields to fit your study needs.
- Eliminates paper-based consent processes for optional elements.
Fully Automated Consent Flow: Reducing Manual Work
Our new automated workflows allow consent events to be initiated automatically based on triggers like participant enrollment, completed events, or timers. Participants can progress independently through inclusion/exclusion criteria, signing consent, and starting study tasks.
- Saves time for research coordinators.
- Supports participant self-enrollment (where permissible).
- Reduces bottlenecks in study workflows.
Customizable Public Sign-Up Process: Enabling More Flexible Patient Recruitment
With an overhauled public sign-up process, teams can create tailored workflows with four optional sections:
- Information text.
- Simple consent for data processing.
- Investigator attributes (optional).
- Subject information collection.
This flexibility ensures your sign-up process aligns with the needs of your study while delivering a seamless participant experience.
Single Signature: Streamlined for Low-Risk Studies
For PMCF and other low-risk studies, single signature functionality digitizes consent collection. Participants can sign electronically without requiring clinician counter-signatures, accelerating workflows while maintaining compliance.
Driving the Future of Clinical Trials
AEC 2024.2 release doesn’t just upgrade consent functionality—it transforms it. By addressing challenges with innovative, participant-focused solutions, we’re empowering medical device manufacturers to manage their clinical trials with confidence and ease.
Are you ready to see how these tools can enhance your studies? Contact us today for a personalized demo and take the first step toward a more efficient, compliant, and participant-centric trial.
