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Oncology clinical trials 3 phase

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.

List of activities, that managed within the EDC system OnlineCRF

Project Phase: Preparation to system set-up

Task:

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.

Our solution:

  • Using the developed checklists, hundreds of checks of primary documentation were performed. Discrepancies were found between the Protocol and the CRF, as well as between the CRF and SAP. The discrepancies detected could severely degrade the quality of the data collected.
  • Fixed divergence and contradictions between project documents for full consistency among themselves.
  • Creation of Data Management Plans based on primary documentation.
  • Creation of specifications for setting up an EDC system.

Project Phase: System configuration

Task:

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.

Our solution:

  • The team formed the requirements for customizing user roles, taking into account the requirements for their access levels and functionality.
  • Separately developed unique roles specifically for the project: a Blinded supervisor user profile has been created. He has access to study dynamics data but without access to patient information.

Task:

Provide effective remote monitoring capabilities for each participating country.

Our solution:

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.

Task:

Provide a convenient communication platform for Query solving.

Our solution:

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.

Task:

To organize the possibility of entering important information into the database between visits. For example, for urgent notification of AE, AR, and ADR.

Our solution:

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.

Project Phase: Users training

Task:

EDC system training for all countries' project teams.

Our solution:

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.

Project Phase: Users support

Task:

Provide support for research teams from 8 countries.

Our solution:

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.

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