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.
What are the EDC features that are vital for each group of users?
- Site Users – Features that are vital for a site user include 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 (See eCRF Design blog), providing 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 eCRF page statuses and outstanding actions (Source Data Verification, Locking, Queries needing review and Closure). 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 (See Reporting in nowEDC blog), with particular attention to trial performance and study data, deliver a nuanced understanding of a trial’s progress.
nowEDC has a range of features to enhance the user experience and ensure seamless data entry.
nowEDC can run checks against data entered by users to ensure that it is correct and consistent.
The two main ways to validate data are “Point of Entry” (performed during the entry of the data) and “Batch Validation” (performed after data has been saved).
“Point of Entry” Validation
In order to ensure that the data entered by users is sensible and consistent, nowEDC performs checks in order to alert the user when there is an issue with what they have entered. Firstly, nowEDC checks to ensure that the data entered is of the correct type, e.g. to prevent “N/A” being entered instead of an expected numeric value, like a “Heart Rate” answer. A check is also made to ensure that answers are provided where they are mandated in the eCRF page. If a question requires an answer and the user does not supply one, nowEDC will alert the user so that they can enter the missing data. Finally, bespoke and “common-sense” checks can ensure that the entered data is sensible and consistent. An example would be ensuring that an “End Date” answer cannot be prior to a “Start Date” answer.
Batch validation rules are run over data which has already been saved in the eCRF page, and in most cases has been Source Data Verified (SDV’d) by a CRA. This allows for more complex interrogation of the data, such as ensuring that an assessment is within the appropriate time since the last assessment, or that a “Respiratory Rate” is not more than 10% greater than the one recorded at the previous visit. These validations are bespoke per study and are designed in collaboration with the appropriate data management team, who can instruct on how they wish the data to be validated.
“Triggers” are the means by which nowEDC can perform essential custom tasks within a study. This functionality is discussed at the beginning of the study build to define the specific needs of the study.
Typical examples of trigger functionality are:
- Opening up the eCRF Schedule when certain conditions are met, e.g. Provide access to Visit 3 for subjects enrolled on Protocol version 2.
- Issuing an alert in nowEDC when certain conditions are met, e.g. When an SAE is saved in the study, an alert is issued to the CRA, Medical Monitor and Sponsor.
- Derivation of answers, e.g. saving a BMI answer when height and weight are saved
- Populating an eCRF page with data upon entry into the page, pre-filling a PK Sampling page with the appropriate timepoints