July 8, 2024
Effective Solutions for Multi-Cohort Patient Numbering
Due to the study's requirements, a complex patient numbering system is necessary.
When a patient is initially created, an automated screening number is assigned based on the site and the sequence number within that site.
Once the patient is enrolled, the EDC system will generate a patient number based on the subject cohort and the sequence number at the study level.
🎯 Challenges
The sponsor required patient numbering to be assigned per cohort at the study level. With multiple cohorts opening simultaneously, the allocation of patient numbers needed to be automated and handled by the EDC system.
How should we address the situation if an incorrect cohort is indicated when the enrollment number is being created?
💡 Solution
The solution specification was drafted and reviewed by all parties, followed by a detailed UAT.
The solution was implemented, and detailed instructions were provided to the study team, such as in the CRF Completion Guidelines.
There was close cooperation between Clincase and the CRO to address any issues.
Email alerts were set up to notify the team when a new subject is created, ensuring they are informed and alerted to any potential errors by site users.
🌟 Results
Cohort-based subject numbering at the study level with email alerts to the study team has been successfully implemented. The system is user-friendly for site users and ensures accurate numbering at the study level, providing a clear overview of patient enrollment across all cohorts.
