The process of collecting clinical data using electronic systems has several key steps. And each of them corresponds to a set of data management services.
Protocol and CRF familiarization
The data management team receives project documents and determines their integrity and sequence, as well as the availability of the necessary parameters to build the data collection process.
Data management plan development
We are developing a data management plan for the study, taking into account the requirements of international documents. Based on this, the electronic system will be tuned, and the data collection process will take place.
System requirements development
Given the project's data and data management plan, the team prepares specifications. The specifications describe step by step the requirements for the EDC system and the rules for its configuration. You can start to configure the EDC system using them.
EDC system configuration
The data managers’ team configures the electronic system. During configuration, we are guided by project documents, specifications for customization, and clients’ requirements. If the client does not provide the set of documents necessary for customization, we can create it ourselves (see services above).
Full EDC validation
Our team checks the components of the EDC system, the presence of the required functions, and tests their work. We also pay special attention to ensuring that the system works seamlessly and allows all users to easily complete the tasks and conduct the User Acceptance Test (UAT).
Preparation of complete set of validating documents
Based on all tests and checks, we prepare a complete set of documentation. This confirms that the system is fully tested and meets the requirements of a clinical trial. These documents are important for both the customer and regulatory authorities.
Training for project team
As soon as the system is configured and ready, our team will organize training for the project team members who will work in the system. This will help to start the research faster and avoid mistakes during use.
Support throughout the study
A team of consultants provides support to users of the EDC system throughout the study. We provide:
- second line support, when we solve those situations that the full-time consultant could not solve.
- first-line support, when the OnlineCRF team directly contacts the users of the system and solves their issues.
At the end of the project, the data management team processes the final database and closes it for further qualitative analysis by statisticians.