7 Essentials for Electronic Data Capture (EDC) Systems

The concept of electronic data capture (EDC) has been with us for many years, however, as technology evolves, the ability to create more useful, innovative and user-friendly solutions also grows. We now live in a world where we expect out-of-the-box solutions which are either cheap or have lifetime free options. We also expect these solutions to respect data privacy, encryption and the provision of constant updates to enhance functionality.

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EDC : The Basics

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Paper and pen still have a place in many circles, and not all organisations or sites will have fully committed to EDC. EDC represents a method by which data can be logged and recorded in a secure manner which can also be retrieved and understood by other persons with sufficient access permissions. EDC can take many forms - it can be a local application on a system (including word processing or spreadsheet software) but might also take the form of cloud-based systems. These systems might be common enterprise software solutions, or more bespoke offerings which cater more specifically for the human participant research sector carefully crafted with regulatory compliance in-mind.

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EDC Absolute Essentials

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User-friendly Interfaces

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• ‍Overview: Clinical research can involve people at many levels, job roles and skillsets. Experienced personnel might have been working very effectively in the industry for decades and never needed to use EDC systems. With sudden changes to data submission and logging, these users might feel thrown in to a complicated process with little time for training.‍
• Tips and what to look for: Look for solutions with large enough fonts and suitable colour schemes. Visible 'call to action' items are important, too - if a user was sat in front of a screen, is it clear what to do? what to click? what to input? If multiple screen resolutions are used - is the application scalable for different screen sizes? If you need help or training, are there training materials or a point of contact for support?

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Role-based Access Control

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• Overview: As outlined in many trial documents, the roles of numerous users will be made clear at the outset. These might consist of, for example: users (i) who can take blood, (ii) who can input results, (iii) who can view records from a particular site, (iv) who can onboard other members of staff to the system and so on.
• Tips and what to look for: Keep things simple! Access can be very complicated. A good system should allow you to take a list of specific tasks and onboard a user with ease and no intimidation. Don't give them unnecessary options or complicated menus they don't need to use. You might find that for certain users with very limited functions, the interface looks very basic. This is perfect and the very meaning of role-based access control. The fewer human input options, the less likely mistakes and human errors can occur.

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Data Validation

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• Overview: Validation is an interesting word which comes up in the human participant research sector frequently. In simple terms in the context of an EDC system, validation enables you to enter the correct data type in each field. This can mean, numbers, sliders, dropdown and, if relevant, "N/A" options.
• Tips and what to look out for: For regulatory purposes you always want to know what data was inserted, when, and by which user. A data collection nightmare (if you have seen our popular series on the subject recently) might be a string of letters in a number-only field. Is there a blank value? Why might that be? Is it clear that it was deliberately left blank? Or did the user forget to input this data? Options for N/A are key here, too, and for analytical outputs, N/D for "not detected" are key as well.

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Audit Trail

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• Overview: For both internal and external audit, concise and clear records are absolutely essential. Even with the best intentions, mistakes will be made. Are they logged? Were they noticed and rectified? When were these records created or modified? By who? and why?
• Tips and what to look out for: While it's not appropriate to constantly expose end-users to a full audit trail (it can be intimidating and complicated), an option for a human readable export of all data is crucial for any EDC system. It's not unreasonable to ask of your EDC provider to give you an audit export on request (or at least an example before your study launches).

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Integrations

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• Overview: Re-inventing the wheel is both cumbersome and pointless. If there are already excellent offerings on the market providing functionality in a specific niche area, you might still need this in addition to your EDC platform of choice. Things like Application Programming Interfaces (APIs) and single sign-on (SSO) are a good sign that your EDC provider wants to work with you, and not ringfence you into being stuck with them.
• Tips and what to look out for: Ask your EDC provider how they interact with other file types and file systems. The more open the better. Will they be open to making bespoke edits or modifications for you? These days, out-of-the-box solutions should also be a collaborative experience in some way. A great EDC provider will also see value in working with you to make their own platform better for you and your teams.

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Support for Mobile and Smartphone Devices

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• Overview: We've reached a point in time where smartphone usage is at an all-time high. What might surprise you is that many users who are 'tech-savvy' and proficient in software spend less than 5% on a laptop or desktop compared with their smartphone. How do we ensure that we are getting value from these people? Can you effectively capitalize on that 95% smartphone use-case?
• Tips and what to look out for: Depending on your country of operation, data, SMS and phone call usage might vary. Your EDC provider should be open to smartphone and web app usage for end-users, as well as SMS systems.

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Security, security, security...!

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• Overview: Last and certainly not least, the most important feature of any EDC is security. With numerous frameworks in place to protect participant data (including GDPR and HIPAA), it is essential that you can trust your EDC platform security.
• Tips: Find out from your provider who owns the data. Where is it stored (geographically)? Is it backed-up? how regularly? What is the password policy of the platform? Do they offer 2-factor security? How does this tie into role-based access control?

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EDC platforms can promise a lot, but industry specialists (particularly sites) find that they are not always up-to-standard. What's more, sponsors seeking to roll-out certain EDC platforms often don't consider sites and their needs. Implementing a solution which is not fit-for-purpose for users at every level can be disastrous and it's a must for sponsors and CROs who frequently work with sites to include them in deciding an EDC vendor or EDC method of practice. The bottom line when working with many stakeholders and end users? - it's often to compromise.