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An improperly configured EDC is the primary cause of data quality issues. How a sponsor can be sure that the system develops in the right way

Published 24.05.2019

One of the most common issues in a clinical study relates to the quality of the clinical data. Sometimes the quality of collected data does not meet the applicable standards. For example, the data may have been entered in a CRF incorrectly, in the wrong format, or a piece of data provided by the protocol is entirely absent. Sometimes data quality problems can be corrected by sending clarifying queries. However, it sometimes happens that the necessary data cannot be recovered. In some cases, poor data quality leads to clinical trial termination and the inability to achieve expected results.

The electronic data collection system (EDC system) can significantly reduce the number of errors and remarkably improve data quality. To collect high-quality data, the EDC system must be configured properly. The most important point of the system configuration is not the set-up of electronic CRF (eCRF) alone, but also includes the setting of roles, accesses, user rights, e-mail notifications etc.

Appropriate EDC system configuration is possible only if a vendor deeply analyzes the study protocol, CRF and configures an EDC while taking into account all project-specific requirements.

Per-protocol EDC configuration is a complex task. One of the biggest problems is that there is no generally accepted list of documents that must be developed to configure an EDC system. If the proper set of documents is not created and specific procedures are not in place, there is a high chance that the system will be misconfigured.

Where is the challenge? The point is that the EDC must comply with the requirements of the study protocol. However, at the same time, the Clinical Study Protocol is a document that was written for a completely different purpose. It is a convenient document for a regulator, a doctor, and a CRO representative, it helps to understand study design, procedures, etc. In other words, the Clinical Study Protocol is a document for clinical research specialists, but not for the Clinical Data Management team. Important information for setting up an EDC system is not included in Protocol. There is no special chapter to describe EDC system requirements. Therefore, for system configuration purposes, the Study Protocol cannot be used directly.

Once the EDC system is configured, we have to prove that it operates correctly, i.e. in strict accordance with documents we have created at the configuration stage. So, we will discuss trial data validation below.

How to prove that the EDC system is configured correctly?

To confirm the right system configuration, the vendor must carry out a trial system validation procedure and document it. Validation is a procedure for testing and checking all system functions. Its purpose is to confirm that the EDC is configured correctly and fits all requirements. Validation of computerized system is a keypoint of multiple industry standards.

Validation is defined as the culmination of evidence that a system
does what it claims to do and will continue to do so reproducibly

Many EDCs available on the market declare that they are validated. However, in most cases, the validity is the attribute of the provided “Platform.” Sure, the initial EDC system is validated and provided to configure it in accordance with the selected study. This system must be changed to collect protocol-defined data (demographics, laboratory, medications etc.), and the system will be invalidated. To make the system valid again, it should be checked again. Sometimes, the EDС provider gives you a system for data collection and does not perform all the required steps to validate it again. It is an oversight with a significant impact on the quality of collected data.

To minimize risks, you may insist on the study system validation procedure before real clinical data collection is started. The EDC system provider can perform this task, and the sponsor can request appropriate SOPs and a list of reports which will be provided as a result of EDC system validation.

What documents ensure that the system is validated?

The electronic data collection system has many customizable modules, and a vendor has to validate each of them.

The main structural components of a system that must be validated are:

  • the basic parameters of the system, for example, user rights, email addresses, visits intervals, the scenario of patient withdrawal, etc;
  • various EDC modules: visits matrix, IWRS module, reports, data export etc;
  • eCRF (correctness of questions, automatic data checks, units for laboratory tests, the correctness of calculated values etc.);
  • new system functions. This item is associated with non-standard system requirements that were implemented at the source code level for a specific project. If the program code of the system was changed, then it must pass through testing and quality control procedures.

Proof of checking each component must be present in a set of reports. When a customer receives these reports, he or she will have real evidence that the system is validated.

The list of minimum required documents that confirm system validation you can download here (*.pdf).

OnlineCRF is a properly configured EDC system.

If you need a fully configured and validated system for clinical research, try OnlineCRF.

We develop EDC for various projects: interventional and non-interventional research, dietary supplements and medical device studies, and implementation of registers. Our team conducts a full configuration and validation of all system parameters.

As a result, you get a ready-to-use EDC, and you can immediately begin collecting clinical data.

Order a free demo by filling out this form.

The validation set

The minimal set of documents which should be
prepared to prove that EDC is validated

Free download
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