PROJECT BRIEF
James Cook University’s Australian Institute of Tropical Health and Medicine wanted a system to ensure clinical trial data collection was in line with ICH/GCP guidelines.
- CLIENTJames Cook University
- PLATFORMCloud Database
- INDUSTRYHigher Education/Research
The electronic Case Report Forms / Electronic Data Capture (eCRF / EDC) system we developed ensures clinical trial data collection remains in line with ICH/GCP guidelines, while maintaining data integrity and participant confidentiality.
RESULTS
Secure, reliable data collection
The eCRF / EDC system was developed to ensure clinical trial data collection is in line with ICH/GCP guidelines, maintaining data integrity and participant confidentiality.
The database employs a number of different security models to tightly control the data staff and participants can access including row level security, table access, column and function security.
It also includes a complex workflow and data entry system so different data can be entered at different stages of the program based on each participant’s start date.
“ Maintaining data integrity and patient confidentiality were key reasons why we chose DB Gurus to develop a cloud database to collect clinical research trial data in line with ICH/GCP guidelines. ”
James Cook University
Paul Giacomin, Ph.D., Senior Research Fellow
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