Monitoring

EasyMedStat's Monitoring module is designed for clinical study teams who need to maintain data integrity throughout the data collection process. It provides a set of tools to track data changes, manage data quality issues, apply electronic signatures, and enforce data entry constraints, all within an integrated environment aimed at supporting accurate statistical analyses.

Audit Trail

• Every change made to patient data is logged automatically.
• Authorized users can view the full history of data modifications.
• The audit trail supports ongoing database oversight and helps ensure data reliability ahead of statistical analysis.

Query Management

• Queries can be opened and assigned directly to study investigators.
• The query workflow supports the collection of quality data in accordance with good clinical practices (GCP).
• Investigators can be held accountable for resolving data discrepancies through the query assignment system.

Electronic Signatures

• Patient forms can be signed, verified, and locked electronically.
• Electronic signatures support remote source data verification.
• The feature is designed to comply with FDA 21 CFR Part 11 requirements for electronic records and signatures.

Bound Values for Data Entry Control

• Authorized value ranges can be set for variables at the time of e-CRF creation.
• These constraints prevent users from entering data outside the defined acceptable range.
• Bound values reduce the monitoring burden by catching data entry errors at the point of collection.

The Monitoring module is part of the broader EasyMedStat platform. It integrates with the platform's e-CRF and statistical analysis features, and its electronic signature functionality is built to meet FDA 21 CFR Part 11 compliance standards.