What is the Electronic Data Capture (EDC) system for clinical trials? Simple beginner explanation
Clinical studies are a crucial stage in the development of new drugs. During these trials, the drug is checked for safety and effectiveness, dosages are specified, and drug tolerance is verified.
A clinical study is conducted with the participation of patients who take the drug under the supervision of a research doctor and also undergo regular examinations.
Regular visits to the doctor-researcher, examinations, passing tests, and instrumental examinations are needed to objectively assess the state of human health before, during and after taking the drug. In the future, based on these data, specialists will be able to determine the safety and effectiveness of the drug.
The collection of these clinical data is the primary process in a clinical trial. It is imperative to carry it out correctly and efficiently. So, modern companies use specialized electronic systems for these purposes. Electronic systems that are designed to collect patient data in clinical trials are called an Electronic Data Capture system (EDC).
How does the EDC system look?
An electronic data capture system is a computer program utilized for collecting medical information during a clinical trial. The investigator enters the patient data into this program. For input use special electronic forms. In the industry, a set of forms in which all data for a patient should be entered throughout the study is called a Case Report Form (CRF).
After all the CRFs are completed, the information is automatically transferred to the database. Inside one EDC system, the data for all patients who participate in the project are stored.
In addition to the CRF, in Electronic Data Collection systems, there are many more functions and modules designed to manage clinical research. However, these functions are not used by an investigator but by other members of the project team.
Who works in the EDC system?
A clinical study is not only the interaction between a subject and a doctor. Many people take part in this process, and each of them has their own role. Recall that the main purpose of the trial is to collect quality data. Therefore, in addition to the doctor who directly enters data in electronic forms, other participants work in the system and monitor the correctness of the data entry and monitor the activity of doctors. Consider the main types of users of the EDC system:
- Doctor — investigator. We already considered this role above. The doctor’s main task is to collect information from patients and correctly enter it into the electronic system, filling in the appropriate fields.
- Clinical research associate (CRA). These are specialists whose main task is monitoring. This means that CRA has specialized functionality in the EDC system, with which it can check the quality of researchers' work. Thus, the monitor can thoroughly prepare for an on-site visit: to identify critical points, evaluate the dynamics of the doctor’s work, and the quantity of the filled CRFs. And during the visit, the employee can quickly and efficiently check the compliance of the data in the primary documentation with the information that is entered into the EDC system. This greatly simplifies the operation of the monitor in the research center.
- Project managers. Control the dynamics of the project as a whole. They ensure that all participants adhere to requirements and deadlines. For their work, the EDC system implements a function that shows summary data regarding the progress of the project and the ability to generate reports. For example: how many doctors began working with patients, how many subjects started taking the drug, which medical centers had already completed the test, and which were behind schedule, etc. The main task of project managers is to keep abreast of the progress of the project, analyze and identify problem areas, and solve problematic issues.
- Representatives of a pharmaceutical company. As a rule, these are representatives of the manufacturer of the drug. Most often, they are the customer and the main initiator of the study. Representatives do not always have access to the system. But, if necessary, a separate interface is configured for them. It helps to monitor the progress of the project but does not give the opportunity to somehow influence the test and change something in it. Thus, the EDC system provides a guarantee that interested parties will not be able to influence the test in any way, and it will be reliable.
We have identified the indicative roles of users who work in a clinical trial. In each specific project, their presence or absence may vary. In some cases, upon completion of the study, regulatory authorities may also request access to EDC data to audit all information.
Instead of a conclusion: Why exactly the EDC system is so significant and commonly used
Thanks to a convenient, customizable interface in the data collection system, all members of the project team can work smoothly. The necessary data are all in one place, and the employee can access them in a few clicks. An alternative to this approach is to conduct a clinical trial on paper. Processing vast volumes of paper documents is far less convenient and efficient. And this has been noted by many companies.
Improving the quality of received information
The EDC system simplifies the collection of information and minimizes the number of errors. So, if all the data is collected on paper, doctors may inadvertently make mistakes: confuse fields, illegibly write a number, etc.
Fields in the electronic system automatically detect suspicious values or missing fields. The system signals this to the doctor, and he supplements the information. This helps to avoid more than half the mistakes and makes it possible to collect reliable, relevant data for evaluating the drug.
Improving the effectiveness of clinical trials and reducing their cost
Thanks to electronic tools, projects take less time and are less money consuming. This is achieved by automating many processes (for example, those described in Section 2), reducing paperwork and all related activities, etc. As the study takes less time and is more efficient, the project budget is optimized.
And this means that, of course, new drugs on the shelves can cost less, because less money was spent on their study, and the quality of these studies has become better. Thus, the use of electronic systems in the development of drugs is beneficial to everyone: from the manufacturer to the final consumer.