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.u
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.
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.
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.
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).
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).
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.
Working with a client consists of a few simple steps. We have built a scheme of Digital CRF's work so that the client spends no more than 8 hours of their time on tasks related to the EDC system. All other activities are completely on our side.
Here are the main stages of the project:
We calculate the price of services individually. The EDC implementation cost is dependent on the volume of information in a CRF, the number of patients, the number of study sites, and the duration of the project. The request is processed within one day.
To finalize the price, we analyze in detail the approved documents, such as Protocol, CRF, the AE/SAE reporting forms, and the Statistical Analysis plan (if available). Then, we create general requirements for the OnlineCRF and prepare a detailed budget for the project. It takes 3-4 days.
Once you provide us with these documents, the first step is an audit by our internal auditor. We analyze the completeness, integrity, and consistency of the information in documents. This helps avoid errors and delays in the EDC system configuration during the project.
DMP provides information on how clinical trial data will be collected and processed in OnlineCRF. When drafting it, we work out in detail all the critical points that are important for the Data Collection, Storage, Data Cleaning, Backup, and Disaster recovery.
To appropriately set-up and configure the EDC system, we create a set of documents that play a role in system requirements. Hundreds of settings should be implemented correctly to configure the system in accordance with the specific project. System requirements allow us not to miss anything and serve as detailed instructions for proper system configuration.
System configuration is the process of setting up an OnlineCRF for a project according to System Requirements. At this stage, the matrix of visits is loaded into the system, and the user roles, AE/SAE reporting forms, and many other things are configured.
Once OnlineCRF is set up for a particular project, the implementation of the eCRF in the system takes place. Each visit is represented by one or several eCRF pages, which will be completed by the doctor. All required forms and reports are also created by the data management team.
We check all functionality of the EDC system, and the correspondence of the paper CRF to the eCRF. After full validation, we prepare validation reports that confirm that the system has been checked at all levels, and it meets the project's requirements.
This step is highly recommended by the GCDMP standard. UAT, in most cases, is performed by an experienced doctor who sees eCRFs from the study perspective. If something is not obvious for the end-user, and it is not very clear what data should be entered into the selected field, this point should be clarified. In the end, if everything is clear for the end user, UAT is successfully passed.
In many cases, OnlineCRF management rights during a data collection period are transferred to the Sponsor. In these cases, we perform live online training for sponsor representatives. The training program takes into account the role in the system of each participant. This will help you clearly understand how OnlineCRF works and what opportunities can be utilized.
When creating accounts for all users, we provide access to the system and also send relevant instructions to users. Finally, CRF.Digital is ready for data collection, and it will be supported by the OnlineCRF team during the course of the study.
The Electronic Data Capture (EDC) system should ideally meet all the requirements of a clinical trial. This is critical to the quality of data collection and project success.
In each study, we distinguish three main blocks of requirements. All of these should be taken into account when configuring the system. Only in this case, will the system be ideal for your clinical research.
