Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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Prepare for the ACRP Certified Professional Exam with our comprehensive quiz. Elevate your clinical research skills with targeted flashcards and multiple-choice questions. Enhance your readiness with detailed explanations and insights for improved performance!

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What must an Electronic Data Capture (EDC) system conform to in a clinical trial?

Data accessibility
Validation
User-friendly interface
Cost-effectiveness

The correct answer is: Validation

In the context of a clinical trial, an Electronic Data Capture (EDC) system must conform to validation requirements because it is critical that the data collected is accurate, reliable, and capable of withstanding regulatory scrutiny. Validation ensures that the EDC system functions correctly and consistently over time, fulfilling the intended purpose of collecting data that supports clinical trial results. This process involves detailed documentation to prove that the system meets predefined specifications and quality standards, allowing for the collection of data that can be trusted for regulatory submissions and comprehensive analysis. While data accessibility, a user-friendly interface, and cost-effectiveness are important considerations for any EDC system, they do not hold the same regulatory weight as validation. Validation is a fundamental requirement that supports the integrity and compliance of the clinical data, making it paramount in a clinical trial setting.