EDC System Validation: How a sponsor can be sure that the system is developing the right way
The electronic data collection system (EDC system) can remarkably improve data quality. To
collect high-quality data, the EDC system must be configured properly. During the configuration
stage, the system should take into account the requirements of the Protocol, regulatory
documents, and the requests of the Sponsor.
In the validation process, the EDC system is verified to meet all requirements.
Below, we will outline the importance of validation, which elements of the system should be validated, and which documents confirm the system’s validity.
Validation proves that the EDC system is configured correctly
Validation is a procedure for testing and checking all system functions. Its purpose is to confirm that the EDC is configured correctly and meets all requirements.
Validation is defined as the culmination of evidence that a system does what it claims to do and will continue to do so.
Each EDC system must be validated after full configuration for the trial
Many EDCs available on the market claim that they are validated. However, in most cases, validity is the attribute of the provided “Platform”. Sure, though, the initial EDC system is validated and able to be configured in accordance with the selected study.
However, this platform must be changed to collect data according to the Protocol of a specific clinical study. After these changes, the system will be invalidated and should be checked again.
You should keep this in mind. As sometimes, the EDС provider gives you a system for data collection and does not perform all the required steps needed to validate again. It is an oversight with a significant impact on the quality of the collected data.
To minimize risks, you may insist on the EDC 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.
The main standards that regulate process configuration and validation
Validation of the computerized system is a key point in multiple industry standards. Among them:
- 21 CFR Part 11
- GDPR, etc.
The requirements of these documents spell out the role of validation, its order and information about the required reports.
Therefore, before embarking on a study, you should make sure that the EDC system and its validation documentation comply with international standards.
Protocol compliance and validation
The EDC system must collect all the necessary clinical data and do so qualitatively. To do this, it must be configured in strict accordance with all the requirements of the Protocol.
Per-protocol EDC configuration is a complex task.
Where is the challenge? The Clinical Study Protocol is a document that was written for a completely different purpose. It helps to simply understand study design, procedures, etc. However, it is inconvenient for EDC-related tasks. Important information for setting up an EDC system is not included in the Protocol. There is no special chapter for describing EDC system requirements. Therefore, for system configuration purposes, the Study Protocol cannot be used directly.
Appropriate EDC system configuration is possible only if a vendor deeply analyzes the Protocol, CRF, and configures an EDC according to that.
Therefore, before setting up, data managers should analyze the Protocol and create a series of documents. These contain all the Protocol requirements in a form adapted to the system configuration.
After setting up the system, it should be tested for compliance with all the requirements of the Protocol. Validation is carried out guided by the relevant SOPs and checklists. Main task: to check whether everything stated in the documentation is displayed and works in the system.
Given this, you must make sure that the Vendor team will configure and validate the system in this way. It is also important that the company has the appropriate expertise and SOPs for this.
EDC system components that must be 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.
What reports ensure that the EDC system is validated?
Proof of checking of 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. Here is a list of key documents that are important in EDC system validation.
|№||Name of document||Description|
|1||Data validation plan||Prepares before starting a system setup. Includes general information about the configuration and validation of the EDC. It contains critical points that need to be checked and documents that report on full testing.|
|2||CRF/eCRF matching report||The report confirms that the eCRF corresponds to paper CRF.|
|3||Test case report||This report is filed for changes that were made in program code EDC. For example, for a specific project, we need to implement new functions. After the implementation of the functions, it is tested, and the test results are presented in the report.|
Free download the Full list of Reports (*.pdf)
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