The primary question you have to ask to choose the right system for a clinical trial
The electronic data capture system’s (EDC) properties and features are critical for clinical trials. The wrong choice of electronic system could lead to errors during the trial and create unsolvable problems during the statistical analyses stage. That’s why choosing the right EDC system should be done carefully, with all possible risks analyzed.
In this article, we will consider the first and most important question that you need to answer when choosing a system. After analyzing and getting the response, you will be able to chop unsuitable systems by more than 50%.
So, the question that you need to answer at the start of the selection process is - will it be “Fully-Configured” EDC or “DIY” EDC? The success of the clinical study depends on the correct answer to this question.
Two main types of EDC systems
All EDC systems on the market can be divided into 2 types:
"Do-It-Yourself - DIY" EDC.
Now, let's see what these systems are and how to distinguish them from each other.
The main difference is how they are configured for clinical research. In the case of the Fully-Configured EDC, a vendor deals with the configuration of the system from beginning to end. The sponsor only has to provide a Protocol and paper CRF. The vendor adjusts the system to meet the requirements themselves. After that, validation is performed - checks for compliance of all system functions with the requirements. As a result, the sponsor receives a complete EDC system and can begin clinical data collecting.
The second type – Do-It-Yourself system (DIY) EDC is designed to be prepared by a sponsor's team, taking into account the requirements of a clinical study. Usually, it comes as a set of individual modules, which the sponsor has to “assemble” into a complete system while conforming with project objectives. That is to say, the sponsor’s team must create and correctly place fields in the eCRF, configure a visit schedule, create accounts for each user (investigator, monitor, project manager), configure each of the accounts in accordance with the users' rights etc.
Besides the setup process, these 2 systems differ in cost. Usually, the price for DIY systems is lower than that of a Fully-Configured EDC. At the same, focusing only on price when you choose your EDC system could be wrong. The low price of DIY EDC should be compensated by a qualified clinical data management team that will set up the system for the project. Considering that the compensation for such a team is quite high, the total cost of a configured DIY may be higher than a fully configured one. Therefore, it’s important not to lose sight of this when you choose a software product.
Why do you need an experienced clinical data management team for EDC system configuration?
A team of experienced data management specialists should deal with the setting up and configuration of the EDC system for the project. A whole team of such specialists works in vendor companies which supply Fully-Configured EDC. They carry out all the procedures for setting up the software and optimize it for a specific clinical study.
In the case of choosing the DIY system, the sponsor also needs a team of at least 3 people who have significant experience in clinical data management.
Here a natural question may arise: “Why do I need qualified employees if DIY systems have user-friendly functionality and allow the configuration of the system using only the visual interface?” It is important to understand that the complexity of setting up is related to the display of clinical study requirements in the EDC system, not only with the mechanism of EDC preparation.
For the system to work correctly, it must fully comply with the requirements of the project. The source of these requirements is a paper CRF and Protocol. However, these documents are not adapted for the configuration of EDC systems. In the Protocol and the CRF, there is no highlight nor described parameters that are needed for configuration, it does not specify what the system looks like when it’s ready.
Therefore, an intermediate stage which will link the Protocol and the EDC is very important for correct setup. This stage is preparing System Requirements Specification. All requirements for the EDC system are written in this document based on the Protocol and the CRF. Requirements are prepared in technical language, taking into account the functionality and capabilities of the EDC. Subsequently, this specification is the basic document that is needed for the configuration of the EDC.
Before you start self-tuning of the system, you need to carefully consider data management terminology and understand how to work with the System Requirements Specification. Only after this will you be able to properly configure the system for the project and not experience any issues in the clinical study process.
Why do you need sophisticated procedures to configure the EDC properly?
We have already figured out that in order to properly configure the EDC system, you need good knowledge of data management activities and experience in this area. As a rule, in responsible CROs that provide Fully-Configured products, the whole team of the corresponding profile work. The work of such a team is regulated, and they all set up processes that are written down in the relevant documents - SOPs.
SOPs are detailed instructions that explain each step in the setting up of a system: starting from the writing of the System Requirements Specification and ending with the creation of user accounts in the ready EDC. These documents are vital because the EDC system is a complicated IT product, and it has many functions, settings, and modules. In order to work correctly with each of them, you should follow the standard operating procedures so you can get a working EDC system.
Let's see at crucial SOPs
Example 1. The SOP “Development of the functional requirement to EDC system”. It clearly describes how to conduct a Protocol and CRF analysis and how to prepare technical requirements for the system based on the obtained data.
Example 2. Another important document is the SOP “EDC System Configuration”. It focuses on the System Requirements Specification and the customization of the system to the requirements of a clinical study.
Example 3. Also of critical importance is the SOP, which regulates the validation of a system: “EDC System Validation”. It contains all the tests and checks that the data management team must conduct to confirm the system is working correctly and configured in accordance with the requirements of the study.
The execution of each of the SOPs is the main factor that guarantees the quality setting of the system. The fact of the execution of each of the procedures is confirmed by the report. Fully-Configured vendors provide these reports to the sponsor, so you can certainly ensure that the EDC is ready, configured and validated.
In the case of DIY systems, these procedures are also necessary. But, in this case, the vendor must be responsible for its compilation and execution. The vendor team should have the procedures and be guided by them when setting up the system. They also must prepare all the necessary reports. It is important to note that the SOPs must be written in compliance with the norms of international regulatory documents (GCDMP, FDA: 21 CFR Part 11). They regulate the basic requirements for documents, the correct terminology, the form of creating reports and more.
This approach will help you to set up the EDC correctly and, in the event of a check by the regulatory authorities, confirm it with the appropriate documents.
How to make the right choice?
The final choice of the EDC system depends on the following main factors:
a team with relevant data management competencies and EDC system configuration experience. If you don't have such, the best solution would be to choose a vendor of Fully-Configured software that will prepare the EDC for data collection in your research;
knowledge of regulatory documents that govern the settings and operation of the system (GCDMP, FDA: 21 CFR Part 11, FDA's). The EDC setting must be done in strict accordance with them;
the presence of formed operational procedures that describe the processes of creating technical requirements, system configuration and validation;
the complexity and riskiness of the clinical study that will be implemented. So, given the issues associated with the complexity of customization, for small amounts of research, academic projects, and short-term research, the DIY system could be a wise and economical solution. However, in the case of large-scale clinical studies, it is better to entrust the EDC set to experienced professionals by hiring a special team or choosing Fully-Configured EDC.