The Development Team created a custom EDC system which supports full life cycle of clinical trials.
The system is a user management system with role-based information access.
User data is stored using Azure Active Directory service.
Project roles should be configurable against the information available to them.
What Was Done
Creation management of instances used in the clinical studies workflow: Centers, Subjects, Users, Payment Visits, Arms
Custom CRF builder
The builder shall provide the possibility to visualize the form, which will carry the fields needed by users, with a possibility to set validation rules for each of the fields.
Study creation workflow. Specific rules should be customizable according to the particular needs of the users.
Specific research arms require specific study workflows within a defined study.
Azure databases and blob storages should be specific for each region, but the data should be replicated between the existing instances to preserve data integrity
Reports should be created for particular phases of the studies, they also need to be exported to xls, csv of pdf format.
Any action, which occurs within the application should be registered and stored in the audit trail and be available in the admin screen
Import. A possibility should be provided to import specific data to the study after validation for data integrity and correctness.