An Alternative Approach to Selecting an Electronic Data Capture System for Your Next Clinical Trial

By Tommy Jackson on February 20, 2024

Consider the End-Users

As I’ve gotten to know the clinical research industry over the past 5+ years, I’ve come to learn that the experience of choosing an Electronic Data Capture (EDC) system for a clinical trial can be a complicated one. What starts as an innocent Google search looking for the most affordable system with experience in your therapeutic area ends up bringing in more questions than answers – questions like, “Why does this industry have more acronyms than the federal government?”

In this article, I will walk through what I believe are the most important considerations for researchers looking to adopt an EDC system for their clinical trial(s).

A quick caveat: I don’t plan to address the basic, table stakes components of an EDC system (regulatory compliance, data security and privacy, validation, etc.). You can find said information here. What I will say is that the EDC of choice should have documentation to demonstrate and prove that each and every important box is checked.

The best approach to choosing an EDC system requires the consideration of all the different end-users, as well as their objectives. Unlike typical software systems that are used by one functional department with similar value requirements, an EDC system supports a variety of different teams with varying (sometimes competing!) value demands. And most of these users aren’t even in the room when systems are being explored.

Below are the different end-users of an EDC system:

  • Clinical Operators
  • Sites
  • Data Managers
  • Quality Assurance (QA)
  • Statisticians
  • Patients*

*In the Animal Health industry, patients can be interchangeable with owners.

Note: Regulators were omitted because study data is usually submitted to them outside of an EDC system. However, a relatively new trend has the FDA beginning to seek direct access to EDC systems to facilitate faster submission times.

Clinical Operators and Sites

Clinical operators include Project Managers, Monitors, and Clinical Trial Managers, among others. These roles typically oversee the planning and execution of the trial. Their interests intertwine closely with those of the sites. The clinical operators are responsible for ensuring that sites and patients have a frictionless experience collecting data in accordance with the trial protocol. The main features this group is looking for in an EDC include:

User-Friendliness 

Most investigators have demanding day jobs and are not looking to spend a significant amount of time learning new technology. They value user-friendliness and are looking to spend as little time as possible performing clinical trial tasks, because every second they spend on the trial is time away from doing their real job. And as anyone with clinical trial experience will tell you, when it comes to clinical research, “a happy site is a happy life.” Consequently, clinical operators are just as invested in user-friendliness as the sites themselves.

Clinical operators’ mission in life is to please investigators, and the collaboration between these two groups begins with training. Clinical operators must ensure investigators know how the EDC database has been built, how to add a subject and enter data, how to respond to queries, and more.

Some specific areas to look for when considering user-friendliness for clinical operators and investigators include:

  • How intuitive is the navigation system?
  • How many clicks does it take to navigate from one section or patient to another?
  • Upon login, do I immediately know the most important things to do?
  • How closely does an electronic form compare to what I’m used to?

Flexibility

It’s no secret that most study builds will go through some sort of mid-study update after the study goes live. Clinical operators need a system that can accommodate change with minimal disruption. Additionally, as a drug, device, vaccine, or other product moves to later stages of research, complexity requirements of the relevant study database increase as well. Having an EDC that is nimble enough to support both early and late-phase research is key to ensuring continuity throughout the research process.

Sites are also not typically involved in the study build or User Acceptance Testing (UAT) process, so the first time they get their hands on the system is also when they are being trained in its use, which is just before first-patient-in. Sites that are truly invested in the trial will almost always have feedback as to how they would like the system to work to maximize their efficiency. Their input often results in changes to form layouts and adjusted edit checks or calculations, among other things. Ensuring the EDC comes well-reviewed, specifically by sites, is critical in identifying the best system to meet your needs.

Reporting Capabilities

To maintain a close pulse of the clinical trial, clinical operators will require important reports that should be easily created and readily accessible. Some key questions they will want reports to answer include:

  • How is enrollment trending across sites?
  • What do adverse event (AE) trends look like?
  • How are patient form completions trending?
  • How many questionable data entries require review?
  • Can reports be produced from multiple sources / forms?

Customer Service

Clinical operators, and by extension sites, will need technical help. Even the most tech-savvy clinicians benefit from having a key point of contact they can call on when they need guidance or help. While an army of data managers may fill this gap for larger organizations, small institutions have the option of working with EDC companies who have veteran study builders on staff to lend their technical expertise, in order to facilitate a seamless experience from study build through closeout.

Data Managers, Quality Assurance, and Statisticians

Data managers, QA, and statisticians are all interested in the capabilities of an EDC as they pertain to data after it has been collected into the system.

Data managers are responsible for designing the case report forms (CRFs) and implementing edit checks and calculations to automate both data collection and data cleaning, saving time on the backend in verifying that all information is accurate.

QA’s role is to create systems to ensure that data collected during the study is properly recorded and documented in compliance with Good Clinical Practice (GCP) and relevant regulatory requirements.

Statisticians make sure that data collected during the study is analyzed appropriately and accurately and then interpreted correctly by regulatory authorities. They also provide input into the patient randomization techniques used during the study.

These roles care about the following items related to an EDC:

  • How quickly can I learn to build in the system? Data managers are universally strapped for time; most have been required to learn upwards of 5 EDC systems. So, the less time needed to learn the new system, the better.
  • What automations are available to avoid repetitive tasks? For data managers, automation around building, re-using databases or forms, bulk actions of all kinds, and reporting are all critical responsibilities that can and should be automated.
  • How is query management performed? Query management is the process of analyzing data and writing feedback to the sites regarding any data that looks awry. A seamless communication capability between QA and clinical operators / sites, with tailored notifications, will be key to ensure high-level trial collaboration across teams.
  • Can I extract the data in a SAS or other format consistent with common statistical programs? While an EDC can often support light statistical reporting, it will never have the capabilities of a more robust statistical program. For this reason, bio-statisticians reserve most of their work in these other systems. Extracting the data in a format they can upload into their respective stats program will be crucial in saving them time and energy.

One thing to remember when considering the differences between the interests of the clinical operators / sites and data managers, QA, and stats is that their priorities often compete. While clinical operators and sites value flexibility, customization, and the ability to change forms and edit checks at any time, data managers, QA, and stats much prefer continuity and stability within the database. While a mid-study update to a database may result in an easier workflow for clinical operators, the process of getting there will require data managers to overhaul much of their well-laid processes, QA to ensure proper testing and documentation, and exporting for statisticians to be a little more nuanced.

Patients

The most easily forgotten EDC user is the patient. Historically, patients most often interacted with an EDC in order to electronically consent to study-specific requirements. Later, the consent of electronic patient-reported outcomes (ePRO) was born, and patients now had specific roles designated by the EDC system that enabled them to have direct access, in order to fill out surveys and other questionnaires.

Patients require the simplest user-experience of all. Like a playground game of telephone, EDC training is passed down in a chain, from database builders to clinical operators to sites to patients. Along the way, technical know-how gets filtered out. It is therefore paramount for patients to only be trained on the bare minimum use basis, so that proficiency might persist throughout the chain, and patients aren’t left at the end of the game staring at the forms, wondering why “Becky bought boatloads of purple ponies monkey chair orangutan.”

When considering patients’ user experience, it is important to remember that not all ePRO products are created equal. Some are rudimentary email systems that only require patients to be at a computer, while mobile apps are also an option. Such apps allow for the patient to receive push notifications and auto-reminders to fill out their survey information, making their experience less invasive and more convenient – they can fill out a survey while watching the ever-lengthier YouTube ads and be done before they’re even allowed to skip to their video.

Conclusion

The secret to identifying the right EDC is to ensure all parties’ input has been included and accounted for in the decision-making process. The best systems will be rich in user-friendliness for each EDC user group, while providing extreme flexibility with minimal disruption to established processes.


Learn How to Make the Switch From Paper to EDC

A Guide for First-Time Electronic Data Capture (EDC) Users

Ready to leave the hassles of paper-based data collection behind? Explore our collection of resources for “Making the Switch: From Paper to EDC” and learn how electronic data capture (EDC) can transform your research.