Electronic data capture (EDC) systems are essential and ubiquitous tools used in the Life Sciences industry by the academic, medical device, biotech, and pharmaceutical companies. A robust EDC system can help you to:
- Streamline eCRF development process;
- Minimize the disruption in the case of the mid-study changes such as a protocol amendment;
- Maximize ease of use for CRAs, sites, Data Managers, and other system users;
- Ensure accurate data to meet the needs of the study.
Everyone involved in the build process including Data Managers and system developers should consider how several key items have an impact when designing a robust EDC system. Keeping these items in mind throughout the development process will ensure an easy-to-use, effective EDC system.
CROS NT and Datatrak have partnered together to help extend service offerings including an intuitive EDC system with the goal of reducing study costs and furthering clinical development objectives. We have asked two professionals directly involved in managing and working with EDC systems to share the best practices for building a robust EDC system.
- Amanda Cross, US Country Manager and Executive Director of Service Strategies of CROS NT
- Ryan Kinstler, Senior Trial Designer of Datatrak International
1. Know the clinical endpoints and the data sources
To design a robust EDC system, you need to understand what data will be collected and how it will support the study objectives. For anyone involved in the design of the system, the very first step should always be to read and understand the protocol, including the study objectives, the clinical endpoints that will determine if the objectives are met, and the rationale behind these chosen endpoints.
From this understanding, you can determine what type of data the endpoints are (multiple choice, free text, numeric, categorical), what the data will look like (coded or decoded) and what supporting fields also need to be collected. For example, if a questionnaire or Quality of Life assessment will be part of the study, will the sub-scores be needed or just the total score? This understanding goes beyond looking at the Schedule of Events, so a good EDC designer will seek to understand the protocol in order to ensure the data collected in the early stages is what is necessary to support the study goals.
It is also important to understand if there will be any additional external data collected (e.g., central lab data or ePRO data) and if it will need to be resident in the EDC system. If so, will it be entered by the site or will it be uploaded from a third-party source? If it will be entered, an entry form that is simple and straight-forward to minimize the site burden should be designed. If it will be uploaded, determine if an API will be needed and who will create it. If only reconciliation will be needed between the eCRF data and the third-party data, be certain you have allowed for the collection of the necessary data to perform the reconciliation to be assured of the data quality.
The questions asked by the EDC development team before beginning work will ensure a well-designed system, allowing for an enhanced EDC experience throughout the study.
2. Design for ease of integration (CDASH)
Regulatory submission is rarely comprised of a single study. To maximize the efficiency of data integration, build the eCRF to CDASH standards. This will minimize the time needed for the creation of SDTM and ADaM datasets, as well as provide full traceability from collection point through to reporting. This will also have the positive effect of reducing the time required for multi-study data integration required for regulatory submissions.
3. Maintain consistency across the configuration
Consistency must be maintained across the EDC configuration. From question and form naming structures, casebook structures, edit check logics, workflow logics, etc., keeping consistency among these items accomplishes several important results.
It makes it easier for any designer to understand how the trial system is supposed to be built. When working with multiple designers, having the same structure throughout the trial build can decrease both the time required to troubleshoot and as well as the time required to implement post-production changes. This also improves the end-user experience with the trial system by making it easier to grasp the flow of the casebook and understand how each aspect of the study functions including edit check logics or workflow logics.
Though consistency across an eCRF build is desired, it sometimes may not be possible and that is an acceptable part of the design process. However, EDC designers should do their best to implement as much consistency as possible, where applicable, during a build to aid in minimizing potential future issues that could adversely affect all parties involved in implementing and using the system.
4. Keep it simple but flexible
A general rule of thumb for any system design is simplicity. When an EDC can be built in its simplest form it should be done to help reduce issues in the future. This reduces friction that an end-user can experience, reduces processing time for each action, allows for easier troubleshooting, and makes mid-study changes easier and faster to implement.
Flexibility is a must to allow protocol changes during the trial to be implemented without undue impact to the database. Considering mid-study changes can be very complex, the EDC system must provide a flexible architecture that allows changes without impact to the users (i.e. downtime) or the data (i.e. migration). Designers can quickly tell during their initial design if a system provides flexibility as specifications change such as casebook generation, calculations, edit checks, protocol changes, etc. This will decrease costs and time taken to program the changes. A modern robust system must provide a simple and flexible design and implementation strategies.
5. Consider the needs of the users
A robust EDC system will meet the needs of all users, providing ease-of-use through a seamless workflow to make everyone’s job easier. Give careful consideration to who will need interact with the EDC system, and in what way, and incorporate these needs into the design. The design and development team should consider the amount of scrolling needed at entry and provide a straightforward layout on the screen with clear (data) entry labels to ensure efficient and accurate entry into the eCRF.
Beyond making the site entry process intuitive, those involved with the design should consider the needs of all other EDC users as well. All users need clear methods to complete their tasks and accurate metrics to manage their area of responsibility. For data managers, this means they need an effective coding and query management system, including reporting. Study coordinators need an intuitive interface for resolving immediate, point-of-entry edit checks. Investigators need an efficient process to review and sign the eCRF. CRAs needs to be able to efficiently review and cross-check the data with source notes as well as understand query status. Medical monitors need to be able to review data and potentially extract it to review in more detail. Each user has a different feature or function that will be most important, and the most robust system meets all of these needs.
Would you like to learn more about designing an efficient EDC? Read our article “EDC Design with the End Users in Mind”.
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 Managers 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 – a program allowing 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?