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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When a CRO moves to an Electronic Data Capture system, what must the new system ensure?

Cost-efficiency and accessibility
Validation, accuracy, reliability, and completeness
Ease of use for investigators
Integration with other systems

The correct answer is: Validation, accuracy, reliability, and completeness

The new Electronic Data Capture (EDC) system must ensure validation, accuracy, reliability, and completeness because these factors are critical in maintaining the integrity of clinical trial data. Validation involves confirming that the system meets required standards and regulations, which is essential for compliance and trust in the data collected. Accuracy ensures that the data reflects what was intended to be recorded without errors. Reliability refers to the system's ability to produce consistent and dependable results over time, which is crucial for making informed decisions based on the data. Completeness ensures that all necessary data points are captured without omissions, thus safeguarding the comprehensiveness of the clinical trial results. In the context of clinical research, these elements help to uphold the quality of the data collected, which is imperative for regulatory submissions and ensuring participant safety.