Making the Switch: Validating Your EDC

Part 2 – Validating Your EDC (Electronic Data Capture) System

If you’re transitioning from paper to an Electronic Data Capture (EDC) system, you may wonder how the EDC validation process works. In Part 2 of Making the Switch: From Paper to EDC, we’ll explore the validation process and answer your most frequently asked questions. 

What Does “Validating Your EDC” Mean? 

Validating your Electronic Data Capture (EDC) system is crucial in ensuring the accuracy and compliance of the data to be collected during your study. By validating your EDC, you are verifying the reliability and functionality of the system to ensure that it works the way you want it to.  

You are looking for reproducibility – consistent results (e.g., an edit check works the same way every time it is triggered) are essential, as they assure the system’s reliability, stability, and performance and enable informed decisions about its readiness. Validating your EDC will identify any potential data collection or storage issues before they become problematic. It is a regulatory requirement for regulated studies and an opportunity to ensure the quality of your research data. 

How Does Validation of an Electronic Data Capture System Differ from Paper? 

The validation of an EDC differs significantly from the validation of a paper-based system. Paper documents can be physically held and inspected. They are controlled documents that require going through many departments, including Quality Assurance (QA), for approval. Version control must be managed as different drafts of any and all documents are approved, released, and made effective. And old paper forms must be shredded. 

Validating an EDC has notable advantages. The EDC validation process is less time-consuming, and the system offers more flexibility for version control and access to historical data. With Prelude EDC, all validation information is contained entirely within the system and includes a record of all edits to the study build. There is also the advantage of being remote when using a cloud-based EDC. Multiple users can be in different locations anywhere in the world accessing the system – reviewing the same, most up-to-date “drafts” and speeding up the approval process. 

What Is the Point of Validating Your EDC? 

Validating an EDC is a critical step in ensuring the accuracy and reliability of the data that will be collected and analyzed. The primary purpose of validating is to reassure regulatory bodies and system users that the EDC inputs good data and that the output data can be relied upon. Regulatory bodies such as the FDA and EU require validating EDC systems to ensure compliance with their regulations. The validation statement, usually from a sponsor or clinical research organization (CRO), must be added to your submission to these organizations describing when and how the EDC was validated. 

But validating your EDC also provides you reassurance and peace of mind. By validating your system, you can be confident that it works as intended and produces accurate and reliable results. 

“Reliability and consistency in data capture are critical to providing quality data to regulatory bodies. By validating your system, you can have the assurance that your system is collecting data to meet regulatory and internal requirements.”

Ann-Marie Kiser, Director of Compliance at Prelude

What Does Validation Encompass?

When validating an Electronic Data Capture (EDC) system, several essential items must be confirmed to ensure everything works as expected. This includes core software (e.g., the functionality of calculations, edit checks, audit trail, etc.) and anything built on top of that (i.e., the study build and configuration).  

Prelude validates its core software. This type of validation is considered an “operational qualification,” answering the question, “does the system work?” This validation includes the following: 

• Testing to ensure the system is adequately secured and protected from external threats. 

• Confirming all the features and functions of the system work as expected. For example, is the audit trail working properly and logging appropriately? 
• Ensuring that there are no bugs or flaws in the system. 
• Evaluating the system’s performance to ensure it can handle the data load. This includes testing how long it takes to render a form and how Prelude EDC performs when multiple people enter data simultaneously. 

Because Prelude EDC is a cloud-based system, an “installation qualification,” which ensures that a system was installed and configured correctly, is unnecessary. 

On the client side, clients should audit the EDC vendor before or immediately after purchase. Vendors, like Prelude, are audited through questionnaires and/or requests for information (RFI).  

After purchase, the client must have a “performance qualification,” also referred to as User Acceptance Testing (UAT). This entails validating their study build and configuration – testing their forms, field entries, edit checks, calculations, etc. Step-by-step, what does that look like? 

1. The client first builds their study using the EDC’s building tool. 
2. Now comes the first round of testing, “first-level testing”. Are all the forms built out with all fields in place? Are the edit checks and calculations working as expected? 
3. The client should create a validation document listing all tests, including edit checks and calculations. The Study Requirements Document (SRD) Field Specification found in each Prelude study is a helpful reference at this point, as it contains the as-built definition of the study database, including information about each field’s properties, edit checks, and calculations. 
4. Round two of testing, “second-level testing” also known as UAT, is next. Testers must run through all forms and fields in the study’s different user roles (e.g., as an investigator, technician, monitor, etc.). All cases, including edge cases, for edit checks and calculations must be tested.  

Prelude EDC’s Feedback tool is used to collect input from testers, allowing them to enter feedback (i.e., change requests) on any field on a study form which, if approved, can be used by study builders to make changes to the study. These data records are helpful when a regulatory authority requires UAT documentation. 

1. Second testers must sign off on UAT. 
2. The client or sponsor’s Quality Assurance (QA) team should review the validation document.
3. And finally, the client must ensure that all parties, including QA have signed off. 

Keep in mind that failures are to be expected during this process so that any problems can be corrected before going live. The validation process ensures that the Electronic Data Capture system works as intended and meets all requirements for use in both clinical research and other applications.  

Once all requirements have been met, the EDC can be considered validated. This validation process is critical as it ensures that the data gathered by the EDC is of the highest quality, accuracy, and reliability.