High quality, clean data capture
To collect accurate data, each hospital site now completes the FIT CRF for each patient online. The eCRF records patient outcomes including demographics, referral symptoms, family history, drug usage, blood results, investigations and diagnoses.
To protect privacy, data anonymisation is enforced with no names collected and information coded by a patient ID number.
The form is configured to highlight out-of-range, implausible, incorrect or missing data for site staff to resolve at the point of data entry. Many fields are dynamic with ‘show/hide’ form behaviour based on user input (e.g. if you select ‘Yes’ to ‘Change in bowel habit’, further options will appear to elaborate).
Fewer queries with electronic data capture
York needed users to provide an explicit response to each question (i.e. not responding ‘Yes’ is not an implicit ‘No’; the user must select ‘Yes’ or ‘No’) to minimise the number of queries directed to sites later.
Consequently, most fields are mandatory, ensuring the sites cannot accidentally miss a field leaving it blank. Meanwhile, real-time validation checks safeguard against forms being submitted with invalid data.
When a site submits a new form, an eMail is sent to admin users to alert them and form data is automatically stored ready for export. The admin team will then update a confidential patient log sheet to record that data has been submitted against that patient ID number.
At the same time, the forms are locked with sites no longer able to edit the form or modify the data. However, admin users can edit submitted form data should any corrections be needed. If the original submission contains several mistakes, the site can ask the admin team to delete the original submission and resubmit the form, something that has proved to be quite useful for Monica and her team.
Faster data collection
In the past, data was unavailable to admin teams for months as sites waited until they had all the information before posting the forms back.
Now, data is available immediately for analysis. Moreover, admin teams can monitor sites as they complete a form, leading to faster query resolution and less people chasing as they can intervene before submission if problems occur.
For the sites, the ability to save a partially completed form and return to it when patient results or diagnosis become available, is invaluable.
Time savings
Moving to electronic forms has eliminated the need for Monica and her team to manually key patient data, resulting in time savings and accelerating data capture. Meanwhile, teams raise fewer queries thanks to data validation rules and checks built into the form.
A successful partnership
From selecting the cloud-based electronic data capture solution, it took eight weeks for sites to begin submitting data electronically following the design, build and implementation phase.
The implementation has been a smooth process. ePC have been really helpful throughout the project. They were able to offer advice when designing / planning the eCRF and help us iron out challenges before they became major issues. Their advice has really helped us focus on what data we needed to collect in order to meet trial objectives and regulatory requirements. I highly recommend them to other CTU’s seeking to implement an eForms system.
Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
Additionally, Monica has been impressed with the support available post-implementation.
The support we have received from ePC is fantastic. They are always available, always willing to listen and whenever we have a question, they provide clear and concise answers. Shortly after going live, we noticed an issue with the FIT. On the form, the site must confirm whether the patient has a functional disease in the diagnosis section. If a user selects yes, the form will show multiple options including incidental diverticulosis but the same option was displayed if someone ticked no, so we were recording the same measure in two places. We notified ePC and they responded practically straightaway and provided us with a quick fix to the problem.
Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
