A NoSQL document based eCRF system for study of vaccines with variable adverse events case study on COVID19 vaccines

Area of Science:

• Computer Science
• Health Informatics
• Data Management

Background:

• Structured databases struggle with unstructured adverse event data from drug/vaccine studies.
• NoSQL, particularly document-oriented models, is suitable for handling such variable data.
• Electronic Case Report Forms (eCRFs) require flexible data models.

Purpose of the Study:

• To develop and evaluate a reporting system for drug intervention studies with high variability in adverse events.
• To manage both structured and unstructured data efficiently using a document-based NoSQL model.
• To create a flexible, fast, and efficient system for collecting and analyzing drug/vaccine adverse event data, especially for COVID-19 vaccines.

Main Methods:

• Applied-descriptive research methodology.
• System requirements defined using Software Requirements Specification (SRS) standards.
• Prototype development of a web-based system, evaluated using User Experience Questionnaire (UEQ) and Application Security Verification Standard (ASVS).
• Comparative performance analysis between MongoDB (document-oriented) and SQL Server (relational).

Main Results:

• The system achieved an average user experience score of 2.31, placing it in the top 10% of results.
• Effective security controls were identified, though improvements in meeting management and authentication are needed.
• The document-oriented NoSQL model demonstrated superior performance in response time and unstructured data management compared to relational models.

Conclusions:

• Document-oriented data models combined with eCRFs are effective for collecting essential data in interventional studies, especially for drug side effects like the COVID-19 vaccine.
• The developed system offers a flexible and precise approach for managing variable and potentially unknown adverse event data.
• The system's usability and security assessments indicate its potential effectiveness, with suggestions for improved external system integration.