Case: blind clinical research in parallel groups to compare a drug for the treatment of prostate cancer: phase 3.
OnlineCRF has developed an Electronic system for collecting data in 8 member countries, as well as organizing and managing research, communication, and remote monitoring. Data collection was carried out with the participation of 35 centers and 184 patients.
Audit of provided documentation.
Comparison of requirements set out in the Protocol, CRF and SAP.
Create technical requirements for customizing the EDC system.
Sponsor provided only Protocol and CRF.
Configure permissions and access for different types of users from varying countries.
In this clinical research case studies, representatives of the Sponsor were not supposed to see a randomization group but had to have access to all parameters of the project's dynamics.
Provide effective remote monitoring capabilities for each participating country.
Added a full package of reports, including custom reports, for comprehensive, convenient monitoring and detection of delays and bottleneck. Among the reports: Project status report, Subjects status report, Visits schedule, and other.
Provide a convenient communication platform for Query solving.
Implemented Query management, convenient for both the doctor and CRA. For this, a Query chat was created. It allowed the investigator and the CRA to communicate in real-time.
To organize the possibility of entering important information into the database between visits. For example, for urgent notification of AE, AR, and ADR.
Implemented the ability to fill out an Optional Form. These are Forms that you can create and fill out without reference to a specific visit.
EDC system training for all countries' project teams.
Training was organized separately for different teams and countries. The training program was compiled individually, taking into account the functional responsibilities of the teams, their access, and roles. We also took into account the previous experience of using EDC systems by users.
Provide support for research teams from 8 countries.
Support for 2-line queries is provided. The OnlineCRF team has worked with user requests from 8 countries. We received and processed various kinds of requests 24\7 during the entire period of data collection.