Making the Switch: Building In an EDC

Part 4 – How to Build a Study Within an Electronic Data Capture (EDC) System 

Welcome to Part 4 of our series, “Making the Switch: From Paper to EDC.” In this installment, we will guide you on how to build a study within an EDC – no coding experience is required! 

An electronic data capture (EDC) system supports proper data entry, validation, and access control, facilitating efficient and accurate data collection for research purposes. A flexible, builder-friendly EDC should allow researchers to configure the EDC system to reflect the study design, including forms, surveys, and assessments while customizing it to match the study’s specific requirements.

I Don’t Have Any Background In Coding. Is It Difficult to Build a Study In an EDC? 

The building process involves three main components: Form Setup, Edit Checks, and Calculations.  

• Form Setup: design the structure and appearance of your forms. 
• Edit Checks: define rules to ensure data integrity and significantly reduce data entry errors – providing feedback in real time. 
• Calculations: automate computations and events to streamline workflow. 

A builder-friendly EDC provides builders with a drag-and-drop interface to group and organize forms and to design those forms – simply drag a numeric field on a form to collect the patient’s weight, for example. It also allows builders, with no coding experience, to create edit checks and calculations. 

But while coding knowledge is not necessary, understanding logic and being able to judiciously blend events that should occur in conjunction is helpful for more advanced functionality. Builders may need to think through logical statements like “If,” “And,” and “Or,” when formulating edit checks and calculations. For example, If an adverse event was entered, then the severity must be indicated. If the patient is eligible to participate in the study, then show the visit forms.

What Documents Do I Need to Start Building?  

The protocol is the primary document needed to start building your study within the electronic data capture (EDC) system. Examples of the study forms can be helpful as a reference, but it’s important to remember that forms in the EDC don’t need to look exactly like their paper counterparts. A flexible EDC provides better ways to design forms, eliminating formatting issues commonly encountered on paper. Let’s say a patient is female and an investigator must indicate if the patient is pregnant. On paper, the “pregnant” question will always appear regardless of the gender indicated. However, in an EDC, you can configure a form to have this question only appear if the gender has been marked “female.” Or take the example of a Concomitant Medications form. On paper, you might see ten blank, provided rows. An EDC can provide only the rows needed; you might only need two.

How Should I Organize My Forms?

A user-friendly electronic data capture (EDC) system is easy to navigate. Content should be organized in a logical and intuitive manner so that finding patient, site, and study level data is straightforward. Prelude EDC allows builders to create patient and site level forms. So, the first step in organizing forms is knowing which level each form will go – the patient or site level. 

At the patient level, organized forms take the guesswork out of the question “what should I do next?” making investigator’s lives easier. In Prelude EDC, forms can be grouped into “form groups.” Each form group typically represents a study schedule item, such as Screening, Visit 1/Day 0, Visit 2/Day 14, Visit 3/Day 28, etc. 

• Screening: This group often includes Demographics, eConsent, Medical History, Inclusion/Exclusion & Eligibility, Baseline Quality of Life, ePRO setup, and Physical Exam forms. 
• Visit 1/Day 0, Visit 2/Day 7: These groups typically include Physical Exam, Randomization, Treatment Administration, Labs, Study-specific Measurements, and Clinical Observations forms. It might also include ePRO surveys. 
• Unscheduled Visit: This group is created in case a patient must come in outside of the visits outlined in the protocol and would typically include a Physical Exam form, among others. For this type of visit, you would want to allow a site to create a fresh instance of this group for as many visits as needed in real time. Learn more about Prelude EDC’s on-demand feature below.  

Forms that do not pertain to a specific visit should live outside these form groups. So, you might have an Adverse Event form group and a Concomitant Medication form group. Other examples include Notes to File, Protocol Deviations, and Dosing Logs.  

For site-related forms, consider Demographics, Administrative documents (e.g., documents that the site must sign), Notes to File, Protocol Deviations, Inventory, and Invoicing form groups. By grouping forms, you can clearly separate forms by form purpose and functionality. 

Tips:  

• Have a plan for how you will organize your forms. 
• Organize your forms into form groups. Referring to the study schedule is helpful. 
• Forms used to collect data outside specific visits should be organized in separate form groups for easy access (e.g., Adverse Events, Dosing Logs, etc.).  

What Features Are Available in Prelude EDC to Help Me Build? 

Prelude EDC provides various features to simplify the study-building process.  

• Build each form once. When you build patient forms, you create a complete set of forms for one patient. The same goes for sites (i.e., when you build site forms, you create a complete set of forms for one site). Prelude EDC automatically creates a new set of forms for each new patient and site added, eliminating the need for duplicate form building.  
• Forms used in multiple visits can be “shared” across visits. Shared forms allow builders to utilize the same form across visits. A Physical Exam form would be a perfect example – it can be shared in Day 0, Day 7, and so on, including Unscheduled Visit form groups. Updates to these forms will appear across all copies in each form group it was included in. These forms can also accommodate specific formatting, edit checks, and calculations for individual visits via Sharing Rules.  
• Forms and even form groups can be marked “on-demand.” On-demand forms and form groups (e.g., Serious Adverse Event form or Unscheduled Visit form group) need only be built once and allow a site to easily create a fresh instance of the form or form group as needed. 
• Repeating sections enable you to create rows of data with the same data fields, with options for a fixed number of rows or dynamic row creation (i.e., a new row will appear as needed). 
• Copy and paste functionality allows builders to duplicate forms, sections within forms, fields, edit checks, and calculations, saving time and effort. 
• Form Library provides the ability to pull forms from previous studies, promoting efficiency and consistency across studies. 
• Modules offer pre-built functionalities that can be easily integrated into your study (e.g., randomization).  
• Prelude’s Standard Form Library includes basic, Prelude pre-built forms with predefined edit checks and calculations (e.g., site demographics). 
• Training database and Preview functionality allow builders to review and test forms before deploying them in a live study. 

“The ‘drag-and-drop’ interface of the builder tool allows anyone to easily create appealing and functional forms. Prelude EDC also allows you to only build a form once, no matter how many times it will be used. This is a huge time saver.”

Grant Neubek, Senior Customer Success Manager at Prelude

How Can We Ensure Our Quality Unit Agrees With How Our Data Is Collected?

To ensure alignment between your data collection methods and the expectations of your Quality Unit, involve your quality team from the beginning of the study design process. Your Quality Unit should be assigned user accounts to readily access the system and participate in training sessions so that they learn about your electronic data capture (EDC) system’s capabilities. This approach, known as “Quality by Design,” allows your Quality Unit to understand how the study built within the EDC system works – how data will be collected and what edit checks and calculations have been implemented. It provides an opportunity to address potential concerns or risks early on. By actively involving the Quality Unit and leveraging the features of Prelude EDC, you can ensure data quality and compliance throughout your study. 

With the right tools and approach, building within an electronic data capture (EDC) system can be seamless and, dare we say…fun! Prelude’s flexible and builder-friendly EDC – with a drag-and-drop interface and robust set of edit checks and calculations, shared forms, repeating sections, modules, and various other features – allows individuals without coding experience to implement solutions for any study protocol. Involving your Quality Unit from the beginning ensures data integrity and compliance, allowing for successful study implementation.