The study of the safety and efficacy of drugs in clinical trials involves active work with patients. One of the main tasks of the project team is to make the study as simple, convenient, and transparent as possible for the participants. In modern trials, these goals are successfully achieved using smart electronic tools.
In this article, we will talk about one of these systems: eConsent or Electronic Informed Consent Forms (eICFs).
What are Informed Consent Forms (ICFs)?
Informed consent forms (ICFs) are what a volunteer will sign before starting any action in a clinical trial. It contains information about all the details of the study, its duration, procedure, etc. ICFs also indicate volunteer rights, obligations, potential risks, exit rules, and other vital points.
This document and its correct preparation are extremely important, as it makes the project transparent and understandable to the volunteer. This protects the person from any unforeseen circumstances, issues, and manipulations. It also helps to make people's participation in the trials more informed and involves them in the project.
Disadvantages of Standard ICFs Signing Approaches
The standard procedure is the reading and signing by the volunteer of the ICF paper form at the medical center, in the presence of the researcher. The volunteer is given as much time as necessary while reading, and he or she can ask questions or make comments. However, this approach has a number of disadvantages. So, it is not always possible to provide information in paper form. In addition, the environment in which the volunteer is located can exert a particular pressure. This makes a person read information faster and leads to a deterioration in perception.
Electronic Systems eConsent
To minimize the shortcomings of paper forms of informed consent, companies are switching to electronic counterparts: eConsent.
This approach has advantages that simplify patient participation in clinical trials and make the project more effective. Consider the main benefits of using eConsent:
- Ease of presentation of information for the patient. Before starting a clinical trial, the main task is to explain the specifics of the project to the patient, explain the rules of the test, and convey information about the rights and opportunities of the person. The volume of such information is often large, and if presented linearly on paper, a person may not understand many points. eConsent electronic modules solve this problem, thanks to their ability to present information in an accessible and convenient form. The informed consent form can be accompanied by illustrations, diagrams, a calendar, and even interactive elements. This helps to provide information for patients in the most understandable way and help people become aware and involved in the project.
- No pressure on patients. Using eConsent programs, the patient has enough time to read and analyze information in a comfortable environment. So, a person is not required to sign ICFs at a medical center on the day the document is issued. He or she can open eConsent at home on a computer, and read it in a comfortable place. At the same time, the participant is not pressured by the situation and time frame, and he or she can deeply and consciously analyze the information. This makes the person more educated and aware of the rules and details of the project.
- Improving the quality of clinical data collected. This item is related to the previous points. Since eConsent helps to increase volunteer awareness, he or she better understands the essence of the study and the sequence of actions. A person can effectively collaborate with a researcher, be more involved in the project, and provide quality data. eConsent modules integrate seamlessly with other electronic systems, such as the Electronic data capture (EDC) system. An example of such an EDC system is OnlineCRF. The integration of the two systems allows you to store all patient data, including signed ICFs and medical information, in one secure location. This way, researchers can have quick access to data, which speeds up research.
eConsent is an important technology that the most advanced countries in the world have adopted at the legislative level. It simplifies the patient’s work in a clinical study, protects him or her from various problems and inconsistencies that may arise during the project. Due to its functionality and ease of reporting, the project becomes simple for the volunteer. And this, in turn, increases his or her interest and involvement.