Transcribing data sucks! But clinical research coordinators must manually transcribe patient data. It’s extremely inefficient, time consuming and highly error prone.
Abstraction of electronic health record (EHR) data and entry into case report forms (CRFs) represent a major barrier for timely data and decision making in trials. The COVID-19 crisis has imposed immense urgency for fast, high quality clinical trial data, and helped make clear that the traditional solution to just ‘throw more people at the problem’ is no longer sufficient.
The medical records in sites’ EHRs serve as the source data for clinical trial participants. These data must be manually transcribed into the study database/electronic data capture (EDC) system, a time-consuming task that adds to the burden clinical researchers are facing in this unprecedented pandemic. The typical challenges that sites run into when transcribing data include:
- A burdensome, manual process, dependent on “swivel chair” interoperability between the EHR and study database
- Transcription errors
- Delays in reporting and payments
- Time-consuming responsiveness to monitors performing source data verification (SDV) and issuing queries, causing staff burnout, study delays and driving up the cost of 100% SDV
Did you know: More than 30% of research coordinators said they experience stress because of the strict requirements in sponsor contracts.(1) All of this leads to delays, high cost, quality risk and staff burnout.
The key to making all of this easier is technology that integrates patient data to make your workflows easier.
Imagine a world where, with a single click, you can get EHR data into your study database.
OpenClinica enables better research faster with an EHR eSource integration to expand the use of electronic health record data in clinical trials. With OpenClinica, you can greatly reduce the burden of data entry for sites by launching eCRFs from within the site’s EHR and securely populating these eCRFs with data retrieved from the patient medical record.
So, why is this a game changer?
Let’s take a look at the impact and value that OpenClinica’s EHR eSource integration had on COVID-19 research.
The OpenClinica solution helped resolve many issues that several sites in COVID-19 clinical trials were facing. For over a year, multiple sites have implemented this solution from OpenClinica, leading to major study improvements that reduce burden, mitigate errors, and save time, money and resources.
A few of the benefits sites have reported after implementing OpenClinica include:
- Increased productivity at the site, leading to higher satisfaction among clinical research coordinators, saving them time. One site said, “The app imports lab and medication data directly from the Epic Chart to the OpenClinica platform, raising data quality and saving an extraordinary amount of time for our coordinators.”
- Reduction in data entry errors, in one case completely eliminating lab errors as part of the SDV process. “These features save an enormous amount of time for our clinical research coordinators, simultaneously eliminating data entry errors.”
- Swift results for sponsors. One principal architect stated, “Our site is now much better equipped to keep up with the demands of a data-rich clinical trial, providing key results to the study sponsor much more promptly.”
- 15x Faster access to data – reducing data entry from 1 hour down to 5 minutes in some cases.
- Strong insights that make decision-making faster. One IT user stated, “Our clinicians have access to summary displays melding research data from OpenClinica with records from the patient’s chart in a way that is not feasible for either system to do on its own.”
See below for full feedback from the COVID-19 trial sites:
“The app performs exactly as expected, enabling the pulling of laboratory and medication data from our EHR at the click of a button. These features save an enormous amount of time for our clinical research coordinators, simultaneously eliminating data entry errors. Our site is now much better equipped to keep up with the demands of a data-rich clinical trial, providing key results to the study sponsor much more promptly.” -Principal Solutions Architect
“Implementing this app was a strategic decision to reduce the transcription errors and the associated time with transcribing medications and labs from our study records to OpenClinica. The implementation was quick and easy in comparison to other implementations. We received excellent support from the OpenClinica team. They were available and ready to help our strong internal team and we were able to shave a full week off our initial projection.” -Project Director, Research/Executive
“The app imports lab and medication data directly from the Epic Chart to the OpenClinica platform, raising data quality and saving an extraordinary amount of time for our Coordinators. Our clinicians have access to summary displays melding research data from OpenClinica with records from the patient’s chart in a way that is not feasible for either system to do on its own. We can’t recommend the OpenClinica app and team enough, and we are thankful our collaboration continues with other high-visibility projects!” -IT User
Capturing better source data faster.
During the COVID-19 pandemic, it has become clear that traditional clinical data capture methods are challenging and changing as a result. Technology is transforming clinical research, opening the door to new ways of data collection that have helped save many lives, launch vaccines and develop medication to lessen the severity of illness. How will you use technology in your next study?