Regulatory Alignment
Compliance and Responsible Recruitment
Trial Scanner is designed to align with the regulatory and ethical frameworks governing clinical trial recruitment. Compliance with applicable guidance is a foundational design principle, not an afterthought.
Core Compliance Commitments
Trial Scanner does not access medical records or protected health information.
The platform does not monitor private patient communities or health forums.
Participation begins only when individuals voluntarily respond to a recruitment message.
All campaign materials are structured to support IRB review and approval before deployment.
The platform optimizes how clinical trial information reaches relevant audiences, not patient identification.
Regulatory Frameworks
Alignment with Applicable Standards
FDA Recruitment Advertising Guidance
Campaign materials are designed to align with FDA guidance on recruitment advertising for clinical trials. All materials are structured to support IRB review and approval before deployment. Advertisements present factual information about the study without making medical claims or implying guaranteed outcomes.
- Campaign materials structured to support IRB review
- Factual information presented without medical claims
- No implication of guaranteed therapeutic benefit
IRB Oversight Requirements
The platform is designed to integrate with existing IRB oversight structures. Recruitment materials and campaign parameters are documented to support IRB submission and review. Campaigns are not deployed without confirmation that appropriate IRB review has been completed.
- Documentation support for IRB submissions
- Campaign deployment contingent on IRB confirmation
- Audit trail for recruitment materials and parameters
HIPAA Privacy Protections
Trial Scanner does not access medical records, electronic health records, or any protected health information at any stage of the recruitment process. The pre-qualification workflow collects only the information necessary to assess potential eligibility based on study criteria.
- No access to medical records or protected health information
- Minimum necessary data collection principle
- Data handling designed to be consistent with HIPAA requirements
FTC Advertising Standards
All recruitment advertising is designed to comply with FTC standards for truthful and non-deceptive advertising. Advertisements clearly identify the nature of the communication. The voluntary nature of participation is communicated at each stage of the process.
- Truthful and non-deceptive advertising practices
- Clear identification of recruitment communications
- Voluntary participation communicated at each stage
Sponsor and IRB Documentation
Structured materials to support review and oversight
IRB Documentation Support
Designed for Sponsor and IRB Review
Trial Scanner's campaign infrastructure generates structured documentation to support IRB submission and sponsor review processes. All recruitment materials are designed to be reviewed and approved before deployment, providing transparency and oversight at every stage of the recruitment program.
Voluntary Participation
Participation Begins with Individual Choice
Every individual who enters the Trial Scanner pre-qualification workflow has done so voluntarily, after encountering recruitment information in their normal digital environment. Trial Scanner does not contact individuals directly or pursue outreach beyond the initial advertising impression. The platform is designed to support the voluntary and informed nature of research participation from the first interaction.
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