In clinical trials, electronic data collection (EDC) systems are at the heart of most research efforts that involve the collection of medical and study information about human subjects in real time during a clinical trial. Also in this article, we will look at what an EDC Clinical Trials system is, the most common features of an EDC Clinical Trials system, the benefits of using an EDC Clinical Trials system, and the difference between EDC and ECRF. In addition, we will also discuss some of the most commonly used EDC systems in clinical trials.
Understanding clinical trials of EDCs
Electronic data capture, or EDC, is a digital record of events, outcomes, and subject-reported information that clinical trials collect. Although there is no one format that all institutions use when it comes to creating and using electronic data collection systems, they typically consist of two main parts:
Electronic Case Report Form (eCRF)
A database where trial administrators store and maintain data from these forms.
For example, EDC clinical trials may collect demographic information about participants as well as their medical history—past and present—and whether or not they are following study requirements, such as medication schedules.
Electronic data collection systems provide both quality and consistency of data, meaning they can be used at all clinical trial sites without adversely affecting the integrity of the trial. However, some EDCs are not as simple to use as other formats, such as paper questionnaires or face-to-face interviews.
Because of their complexity, you may want to seek out a clinical research organization (CRO) that specializes in or has experience with EDCs to learn more about how they can benefit your clinical trial.
The benefits of electronic data collection should be carefully considered before deciding to implement EDC for your clinical trial. For example, because EDCs are digital, their content can be accessed from anywhere and anytime with internet access.
This makes them ideal for international and remote trials, as well as those held outside normal CRO working hours or on weekends. They are also easier to monitor than paper questionnaires and can increase compliance by providing participants and site staff with more up-to-date information about study requirements and status.
What is EDC Clinical Trials in Pharmacy?
The goal of the EDC Clinical Trials system is to improve efficiency by making it easier for researchers, clinicians, operational staff and site staff to access essential data while minimizing data collection errors. Using the EDC system for pharmaceutical clinical trials facilitates the integration of data from different sources, resulting in faster access to information. This can help teams make more informed decisions and ultimately accelerate clinical development.
Another benefit of using your EDC is that it helps ensure data security as all information is backed up at least once a day and more frequently during collection. They are also easy to update – for example, if you are conducting a study with several drugs or groups of patients, you can add relevant information with just a few clicks in a central database. This means that changes can be made instantly across multiple documents, helping to eliminate errors.
EDC Clinical Trials systems also help improve compliance by streamlining workplace data collection and laboratory analysis. They can also help speed development by providing tools for compiling and organizing information for regulatory submissions, such as FDA submissions.
Why are EDC Clinical Trials needed?
A clinical trial is a scientific study of people who voluntarily undergo a treatment that is tested to see if it is safe and effective. Because there are many clinical trials in different phases and with different goals, a system is needed to keep track of all this information.
One way clinical trials collect data is through electronic case report forms (eCRFs). Case report forms have been standard practice in Phase II and Phase III research for years. Today, however, electronic data capture (EDC) systems offer significant advantages over paper-based processes. The use of EDCs can significantly reduce reporting costs and time, as well as improve patient safety by more easily detecting adverse events earlier in the study.
A big advantage is that eCRFs facilitate the recording of adverse events and their communication with other stakeholders. Because large clinical trials can span many countries, regions, and time zones, it is important that events are reported quickly and accurately to ensure patient safety. Also, eCRFs have already been adopted by regulatory bodies such as the FDA as part of their Good Clinical Practice guidelines on improving data quality in clinical trials.
EDCs should be able to track relevant clinical trial data such as treatment and vital signs. eCRFs cover all aspects of trial registration and participation, but this is only one part of EDC. Each clinical trial has three basic phases:
- Patient recruitment
- Data Collection
- Analysis, quality assurance, reporting and closure
Differences between ECD and ECRF
ECRFs contain electronic records that must be completed and signed by each clinical trial participant at a specific time during their participation in the clinical trial. The ECRF details the responsibilities of both parties in the clinical trial.
ECRFs can either stand alone or be part of an integrated electronic data collection (EDC) system. The main difference between ECD and ECRF is that participants are required to provide specific data within a specified time limit for each event defined in the study protocol through the ECRF, but not through the EDC Clinical Trials system.
While ECRF collects information from each participant separately, ECD provides a centralized system for collecting patient data. Using EDC reduces potential duplication by avoiding multiple entries for each participant, making data analysis simpler and easier.
In addition, if technical problems occur while entering or exporting data from one device to another, there is no need to re-enter all the data manually; instead, erroneous entries can be automatically excluded. Finally, because it allows for backup in case of lost or damaged recordings, you do not risk losing your participants’ personal data.
If a researcher wants to collect specific data from each participant in a clinical trial, the ECRF is more efficient than the ECD system. In addition, participants are more likely to complete studies if they are provided with a high level of privacy and anonymity, making it easier for them to trust and rely on the ECRF.
How do you use EDC systems for clinical trials?
Electronic data capture systems, or EDCs, are use in clinical trials to help researchers enter and manage data from study participants. This can do in several ways, such as a paper form or electronically via tablets or computers. Every study needs some kind of data entry system, but each approach has its pros and cons.
Data collection for EDCs can be in a variety of formats, such as questionnaires completed by an on-site researcher or an online survey completed at home by the patient. Most people think of surveys when they hear EDC, but there are other options like real-time data entry (RTDE) and real-time eligibility (RTE).
These two processes allow study teams to conduct exams and tests and immediately enter or update the results in EDC. This allows researchers to track information without having to wait for each participant to physically report their data.
Another feature of EDC systems for clinical trials is a central data repository where information from multiple trials is store. This allows researchers to share data across a number of studies, helping to understand how certain drugs may work or whether there are any associate side effects.
Combined with other technologies such as barcode scanners, the EDC Clinical Trials system can store and track much more complex data than just patient-level details. There are no restrictions on what kind of information an EDC system can contain, and many are design to handle any type of clinical trial data you might need.
There are several tools that can help study teams manage their EDC system. These include logging into a central database via computer, tablet or smartphone, and special applications that track your data and perform tasks such as data entry and verification.
It is important to choose a good logging tool because it makes everyday tasks much easier, especially if you have limited experience using an EDC system. The best ones have pre-installed scripts for common clinical trial activities like questionnaires and eligibility checks, so you can take care of these tasks without having to write them yourself.
Common features of the EDC system
Every clinical trial requires some kind of structured data collection. That’s why many organizations choose to use an electronic data capture (EDC) system to store information from studies, including patient data and objective outcomes, such as whether a drug is effective.
The first feature you should aware of is that EDC Clinical Trials systems must able to interact with clinical research software – in other words, they must integrate into existing IT infrastructure. All of these systems offer basic compliance services and are able to record changes made by users so that anyone can audit any changes made in real time. Data from multiple sources can also easily access and securely manage through a single system.
Additional benefits of using an EDC system for clinical trials include safety, convenience, and standardization. All test data is process through one system, making it easy for multiple workers to access it from any location with internet access.
EDC systems for clinical trials
This allows researchers to work from home or at the patient’s bedside, giving them greater flexibility during trial periods. As previously mentioned, different studies also require specific information and different types of reports. Instead of tracking everything separately and then manually entering the require data into a spreadsheet or database – which takes a lot of time – EDC systems provide a centralize repository of information that can easily access at any time.
Some clinical trials require only basic data, while others require more complex data. This is why some organizations need an electronic case reporting form (eCRF) to manage trial information instead of just an EDC system. Both can use to store important patient information such as name, age, gender and general health status.
However, unlike EDC systems-which can easily access from anywhere with Internet access-eCRFs typically require users to manually enter information on their computer screens. Therefore, many choose to use both systems together if their clinical studies have a high degree of customization.
What are the benefits of using EDCs for clinical trials?
While EDCs are design to help simplify electronic data capture and reduce human error, they do not always offer a user-friendly interface. Some patient demographics may complain that they are too tuff or simply not intuitive enough. You may be require to provide basic training on the use of the program as part of the trial version.
You can better protect your participants’ privacy and stay compliant with EDC, where users can enter their information in private. By incorporating workflows that automate data encryption, you can collect encrypted data from participants and store it securely on servers with a single click—all without having to remember a password.
You’ll also be able to track changes made during data entry through audit trails, so you’ll see what happened before, during and after each stage of electronic collection. This will help you keep your database up-to-date while notifying you if there are any changes that could affect a participant’s eligibility or treatment plan. This will help your study to have more accurate study results as well.
Your patient data will be more accurate and consistent with intelligent built-in validation logic to prevent common data entry errors. When certain conditions during data entry, an action can triggere automatically.
For example, if a patient’s weight is lower than at a previous visit, an alert may prompt you to manually review those results before submitting. This is ideal for keeping your database up to date without the risk of manual error.
You’ll also be able to spend less time entering data and more time doing what you do best. With the EDC system, you can collect your study data quickly and easily, so you don’t have to waste time manually entering it into a separate database or spreadsheet.
Many EDC systems allow you to enter some information directly from your iOS or Android device – no desktop computer needed! This will give your patients more options to enter their data.
Examples of electronic data collection systems
EDC software can range from proprietary programs to some of today’s most popular cloud-based software products. Most of these you should be familiar with if you work in clinical research – but if not, here are a few examples for you and your team to review: ClinCapture, TrialKit, FORM OpX, Marvin EDC
You can create or request an account to use for most of these programs to test them out. You will need to install some software on your computer or mobile device to start entering and managing data right away. There are other cloud programs that you can use in your browser.
Some of these products have so-called add-ons – different parts of their system design for specific data collection tasks such as surveys, questionnaires and more. These components may need to install or pay for separately depending on your platform and software.
The nice thing about many of these systems is that they can access from almost anywhere. You may have access to several different programs depending on your job duties, but you’ll likely use at least one of them regularly if you work in clinical research.
It’s important to understand how these tools work and what they do, because their capabilities—and your ability to use them-may vary depending on your job responsibilities. For example, some workers expect to enter data as part of their job, while others do not enter data at all. Knowing how each system works can help you better understand if you need additional training or if any particular add-ons may affect the way certain tasks.
We’ve only looked at a few of today’s most popular EDC systems, but there are many more options available. You can take a closer look at the EDC Clinical Trials system to get a better idea of how it works and whether you need additional training to use it. Many EDC software programs allow you to have a trial period.
EDC software companies usually offer some kind of training for current or potential users. By taking advantage of additional learning opportunities, you will become even more familiar with these tools and be able to do your job in an efficient way that is safe and effective for everyone involved in clinical trials. Using an EDC is a great way to help manage your clinical trial, no matter how big or small your trial is.