Self-Assessment Scorecard

For DHTs used as data capture devices in clinical trials (RWE)

DHT Compliance Readiness Self-Assessment Scorecard

Select Your Stakeholder Type

This self-assessment tool provides a preliminary evaluation of compliance readiness for Digital Health Technologies (DHTs) used as data capture devices in clinical trials for Real-World Evidence (RWE) generation. The DHTs are not part of the investigation but serve as tools for data collection.

Note: This is a simplified self-assessment tool for informational purposes. The scoring methodology and detailed remediation strategies are proprietary. For comprehensive compliance evaluation and specific regulatory guidance, professional consultation is recommended.

Please select your stakeholder type to begin the assessment aligned with EU MDR (Medical Device Regulation), FDA DHT (Digital Health Technology), and DCT (Decentralized Clinical Trials) guidelines.

Biopharma / CRO

Sponsors and Contract Research Organizations using DHTs in clinical trials

Logistics Supplier

Companies providing DHT distribution, support, and logistics services

DHT Manufacturer

Manufacturers developing and producing DHTs for clinical trial use

Choose Assessment Type

Select the assessment type that best fits your needs:

Quick

Quick Assessment

10 essential questions covering critical compliance areas. Takes approximately 5-10 minutes to complete.

Best for: Initial screening, quick compliance check, or time-constrained evaluations.

Advanced

Advanced Assessment

Comprehensive evaluation with detailed questions across all compliance dimensions. Takes approximately 20-30 minutes to complete.

Best for: Thorough compliance audits, detailed gap analysis, or pre-deployment evaluations.

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Overall Compliance Readiness Score