[Numeric case report: realization and practical utilization in cardiovascular research]

Area of Science:

• Cardiovascular Medicine
• Clinical Research Methodology
• Health Informatics

Background:

• Clinical trial reliability hinges on rigorous design, execution, and data recording.
• Ensuring data quality is paramount for valid research outcomes.
• Traditional data collection methods can present challenges in real-time monitoring and data integrity.

Purpose of the Study:

• To describe the application and benefits of digital Case Report Forms (CRF) in clinical research.
• To demonstrate how digital CRF facilitates high-quality clinical trials adhering to Good Clinical Practice (GCP).
• To present a case study of a Phase III multicenter trial utilizing digital CRF for antihypertensive drug efficacy evaluation.

Main Methods:

• Implementation of digital Case Report Forms (CRF) using microcomputer technology and user-friendly software.
• Real-time data monitoring capabilities for ongoing clinical trials.
• Ensuring data continuity from investigator sites to statistical analysis departments.

Main Results:

• Digital CRF provides a robust tool for monitoring trial data in real-time.
• The system ensures seamless data flow and continuity.
• Facilitates adherence to Good Clinical Practice (GCP) standards.

Conclusions:

• Digital CRF significantly enhances the reliability and quality of clinical trials.
• This technology is crucial for efficient data management in cardiovascular research.
• The application demonstrated supports the evaluation of therapeutic interventions like antihypertensive drugs.