User experience is important within any software as it focuses on ensuring the product is doing its job correctly and in the most helpful way. An EDC system designed with the end user in mind streamlines data capture for all clinical trials and leaves a favourable impression. A poor user experience, on the contrary, tends to make users frustrated, impatient, and even angry. Additionally, it increases time spent on building and managing studies and subsequently slows down the delivery of the therapeutics to the patients.
We talked to two professionals directly involved in the creation and configuring of EDC systems to understand what EDC user-friendliness stands for, how can EDC vendors help users to avoid study build errors and how can the right EDC boost the clinical trials efficiency:
- Monica Pimazzoni, Director of Clinical Data Management, CROS NT
- Niki Kutac, Sr. Director of Product Management and Marketing, Datatrak
What does a user-friendly EDC mean?
Niki Kutac (NK): It means having features that provide simplicity and efficiency when sites are entering data and the study team is cleaning and reporting on the data.
Monica Pimazzoni (MP): At the most basic level, a user-friendly EDC system is a system that is intuitive and easy to navigate for each of groups of users. While this sounds straight-forward, getting to user-friendly requires that the developer has a thorough understanding of each user’s role and how they will interact with the system. This includes data managers, site personnel such as study coordinators and investigators, CRAs, project managers, and the extended clinical team including medical monitors. Each role has very specific reasons to access the data in the EDC system, and they each need it to be as simple and efficient as possible to complete each task.
What are the EDC features that are vital for each group of users?
NK: Each of the user groups has their own, very specific needs:
- Site Users – Features that are vital for a site user is a straightforward navigation and an intuitive interface for easy data entry. Some examples of the intuitive interface are the ability to only display questions and forms when needed, providing instantaneous feedback on data through edit checks, and providing workflows to help guide the user.
- Monitors – Features allowing more effective data cleaning are essential for Monitors; like easy identification for forms status and actions needed (Source Document Verified, Locking, Queries needing review and Closure). The ability to perform data cleaning at multiple levels for example; In Batch, Subject, Visit, Form, or on the question level, allowing a user to perform their function based on their needs. Giving a user the freedom to perform their job, as they like to work, helps them perform the task efficiently.
- Sponsors – It is necessary for Sponsors to see the progress of the study. Easy to run detailed reports, with particular attention to trial performance and study data, deliver a nuanced understanding of a trial’s progress and hang-ups.
Monica, would you like to cover EDC features that are important for data managers?
MP: Sure. Data managers, as all other user groups, need clear methods to complete their tasks and accurate metrics to manage their area of responsibility.
This means data managers need an effective coding and query management system, including reporting with metrics and dashboards. In additional an easy and clear eLearning platform is a key to training and making users proficient in using an EDC system.
How can we give the users an easy way to provide accurate study data?
MP: In this case, we think of the users as the study coordinators or other site users who will be entering data. The EDC system should support ease of entry, while providing immediate feedback on ‘questionable’ or inconsistent data. There is a definite balance between programming enough immediate edit checks to get the cleanest possible data and not too many that the site user becomes frustrated and entry is delayed. The eCRF should be designed in a way that allows an easy navigation and CRF fields should be designed incorrect format and with guided answers, for exampledrop down lists with predefined list of allowed values.
NK: Also, designing a casebook to work with the data automatically reduces errors therefore increasing accuracy. By only showing questions and forms that are needed, reduces the possibility that data is entered into a field when it logically shouldn’t. For example, only show ‘Other Specify’ text box when ‘Other’ is selected or only display a Pregnancy form when the subject is a Female.
What can we do to reduce the human errors in data entry?
MP: I would say that careful, thoughtful and targeted immediate edit checks have the biggest impact. When the EDC system is developed to flag inconsistent or out-of-range data, the site can immediately investigate and make corrections.
Data Managers will also do a ‘holistic’ review of clinical data across all sites to detect early possible systematic errors in the data-entry process and implement timely corrective and preventive actions. This can include further training for the site, data-entry guidelines, and triggering a monitoring visit at the site.
NK: From technology point of view, we can provide automation and remove redundancy. This helps us to reduce the number of human errors in a study. Providing error checking automatically upon data entry allows a user to see logical errors as soon as they enter an answer into a field allowing them to fix the error immediately, saving time later on.
Another important but often overlooked task that helps reduce these types of errors would be training. I can’t agree more with what Monica said – accurately training users provides them with the confidence and knowledge to effectively perform their tasks and reduce the mistakes that could be made from an improperly trained user.
How can an EDC system that was designed with end users in mind, boost the clinical trial efficiency?
NK: It improves the user experience overall, which directly increases the speed of data capture and cleaning. Getting data entered and cleaned in an EDC faster allows a faster database lock and analysis, which can lead to a trial’s success and ultimately getting to market faster.
MP: The effect of efficiencies at the beginning of development increases throughout the study. A well-developed EDC system will allow for more accurate and easier data entry, which means reduced lag time from patient visit to entry. The CRA will then be able to more quickly monitor against source data and review the aggregate data to look for site trends. Potential issues can then be found quickly and resolved early on.
An efficient query process means sites, CRAs and data managers can quickly create, answer and close queries, keeping the data clean as the study progresses. An easy to review eCRF means investigators can review and sign final eCRFs efficiently, making the most of their valuable time. Taken together, the time to locked database after LPLV is minimized. This allows the statistical analysis to be performed without delay, giving a sponsor necessary access to decision making data.
How can CROS NT support your clinical trials?
Our clinical data management team has extensive knowledge in the management of data generated in Phases I-IV and medical device trials. The team is expert in various data collection, reporting and visualization systems.
Key facts about our Data Management team at CROS NT:
- 15 Data Mangers in Europe
- DM Leader with 25+ years’ experience in pharma/CRO
- 20 ongoing studies
- 10 new projects each year from phase I to IV, NIS & registry
- Setup in 6-10 weeks for large trials and 4-6 weeks for simpler studies
In 2014 we have expanded its Life Sciences technology portfolio by joining the DATATRAK Connect™ Program – a program which allows for extended service offerings for the drug development process with the goal of reducing study costs and furthering business development objectives.
Under this partnership program, we can provide core DATATRAK’s clinical trial technologies:
- Electronic Data Capture & reporting (EDC)
- Randomization and clinical trial supply management (RTSM)
We leverage our expertise and experience to enhance the quality of your data. Would you like to learn more about our data management services and EDC portfolio?