How to choose the right Electronic Data Capture System for your clinical trial. Quick beginner's guide
An Electronic Data Capture system (EDC) is a powerful tool for managing clinical trials. It allows the user to collect the necessary data, analyze, and distantly monitor the trial’s dynamic and its status and so on. At the same time, the EDC system is a sophisticated software package containing numerous functions and settings. That is why it is so important to have special knowledge and skills when choosing the right software for a particular project among numerous options on the market. In this article, we are going to give you an insight into the most important causes to be considered when selecting an EDC. So, even a beginner will be able to choose a suitable system.
The main difficulty faced when choosing an EDC is the number of systems designed for different types of projects and clinical trials.
Some are better suited for conducting pre-approval clinical trials, others are tailored for post-marketing research. There is also a third type of EDC for long-lasting data collection related to patients with certain diagnoses (especially orphan diseases). Such systems are called registers.
Each of these systems has special features to match project demands perfectly. It is very easy to select the wrong system when you don’t consider these features. Spending a fortune on the best EDC of its kind doesn’t necessarily ensure that it is going to be convenient and functional. If this happens, the user will have to spend additional resources to learn how to use the system and correct the mistakes that have been made. So, the reason for failure might very well be an incompatibility between the system and the project.
For instance, a small amount of research in phase I is planned but the system you have is designed for a large-scale interventional trial. It turns out to be a complete waste of resources, as long as you don’t need such powerful and complex functions, which are provided by such a system, for a small project.
So, how to figure out the EDC suitable for your specific needs?
Here is a simple three-step plan to follow:
Step-1. Determine the type of project and evaluate whether the system meets its requirements (PMS/CT/Registry).
As has been mentioned above, choosing a matching EDC is key.
First of all, determine the type and the main features of the project. It might be:
- A phase I interventional clinical trial;
- A phase II - III interventional clinical trial;
- Post-marketing study;
- A register of rare diseases, and so on.
Each of these projects require absolutely different EDC systems.
Next, determine the most important parameters of the project, such as: duration, the number of patients, visits and investigational sites.
The main thing to ask your provider is whether this EDC is suited to your specific project. If the answer is positive, ask additional questions, considering the main features of the project, which were stated above. Then it would be easy to find out if the EDC has all the functions you need.
Step-2. Decide the way to configure the EDC system to your project and who will do this.
There are 2 ways to adjust. The user either does it themselves or gets it done by the EDC provider.
The first way is by using a DIY (Do It Yourself) EDC. The sponsor adjusts such systems themselves and it requires some specific skills, such as:
- Being able to draft a document for the system’s configuration. Experience with system Technical Requirements formulation and other documentation is needed. It enables reflection of the Protocol and CRF requirements with maximum accuracy because these documents themselves are not adopted for EDC configuration at all;
- Standard operational procedures for EDC configuration. This point actually comes from the previous one. To create correct technical documentation to be followed by EDC adjustment, a set of Standard Operating Procedures is mandatory. Those are the specific instructions on how to adjust the system considering the demands of the project. Without it, the risk of adjusting the system incorrectly is pretty high;
- Understanding the standards and requirements of the industry (GCDMP, GDPR, FDA 21 CFR Part 11). It is important to configure the documentation and the EDC itself according to international document requirements. It should guarantee high quality of the data collected and will help to prevent issues in case of regulators’ audits;
- 24-hour customer support. To provide technical support, a provider needs a comprehensive understanding of the systems` capabilities and of the issues that may occur. That is why the experience of operating such systems and being aware of your specific system`s features is so important.
The second way is getting the job done by the vendor or CRO. Such products are usually called ‘Fully Configured EDC.’ What the user needs to do is to provide the vendor with Protocol and CRF. It will review and check those documents, formulate the Technical Requirements and configure EDC accordingly. The vendor will validate the system afterward and provide the user with a set of validation reports.
In this case, the user gets an adjusted system ready to collect the clinical trial data.
Step-3. Decide how the monitoring of the project will take place.
Monitoring is one of the most important procedures in the clinical trial. It helps to identify and eliminate all issues, mistakes and data inconsistencies in the project. That is why the procedure itself has to be as convenient as possible.
EDC system allows keeping track and evaluating the dynamics of the project (remote monitoring). If the user intends to monitor the project using the system, one has to decide who exactly is going to perform this:
- The user and/or ones team.
- The vendor’s team or CRO.
In the first case, identifying and eliminating all issues during the clinical trial is the user’s team responsibility, so inquiring whether the system has a special user-friendly interface, which helps to do this fast and conveniently, would be a great idea. Also, whether the vendor would be able to provide your team with training on how to operate the system to monitor the project. It is a great way to find out how convenient it is to monitor using a specific system and select one that has the most user-friendly interface.
In the second case, it is the CRO’s responsibility to monitor the project using the system. The cost of the EDC system does not usually include the cost of the vendor’s service - so it should be discussed and agreed beforehand.
We have discussed three main points that will help the user choose the EDC system for clinical trial:
- Determine the type of project and evaluate carefully, whether the system meets its requirements for collecting and monitoring data.
- Decide the way the EDC has to be adjusted to your project and the person who will do this.
- Decide how the monitoring of the project has to be performed.
When considering all three points, there will be fewer options left. The next steps depend on the features of the user’s project, experience, and the project budget. We will talk about all these points in the following articles. Subscribe to our news to receive upcoming information.
We have prepared for you a useful detailed scheme for selecting the appropriate system. It is available for free download on the link.