In recent years, there has been a lot of discussions, and frankly, a lot of confusion, around the use of electronic source (eSource) data and its potential to transform the clinical trial industry. One of the major misconceptions regarding eSource is that it is the same as an electronic data capture (EDC) system, and some confuse it with electronic health records (EHRs). Similarly, some companies market eSource solutions by advertising a “scanned paper approach” whereby clinical trial personnel record the trial data on a paper, scan that paper into a computer, and then upload it to their “Dropbox-like” platform.
In this article, we will attempt to once and for all clear up these misconceptions by discussing what eSource is and what it IS NOT.
What is eSource?
Source data refers to the initial data recording, whether it is a trial participant’s blood pressure reading or the documentation of a new adverse event. eSource is simply the digitization of source data, meaning that the initial data collection is performed directly into an electronic system. According to the U.S. Food and Drug Administration (FDA) guidance document, eSource data refers to “data initially recorded in electronic format.” eSource eliminates the need to maintain a paper source, helps reduce mistakes, and produces cleaner, more reliable data.
Let us take a brief look at some of the advantages of using eSource:
- Original and contemporaneous data: The data is captured directly into an eSource tool when the patient is in the exam room and thus, is the true source data.
- Increased speed of data entry: Entering data directly into an electronic tool saves countless hours spent by the study coordinators in transcribing and scanning paper documents.
- Increased data reliability: Minor yet time-consuming and frustrating mistakes are easily avoided as the data entered by the clinician is automatically validated. The study staff can look up existing data and answers to previously asked questions to ensure no data inconsistencies.
How is eSource different from EDC and EHR?
While eSource data is the original data collected directly into an electronic system, electronic data capture (EDC) data is an electronic copy of the source data. For instance, the trial data is initially recorded on a paper form, then the critical data required for clinical trial analysis and reporting is entered off of the paper source into an EDC system. Thus, EDC is not the true source but is a subset of the source data.
On the other hand, an electronic health record (EHR) is a digital version of a patient’s chart note. Like eSource data, EHRs are real-time and contemporaneous and are utilized by authorized personnel to view patient records instantly and securely. However, it is essential to understand that EHRs are not designed to support clinical trials in the same way as eSource. EHR systems use standardized templates for documenting patient encounters but not for clinical trials, which have highly detailed, structured, and protocol-specific data requirements. Reconfiguring EHR data templates to follow the rigid clinical research workflows is not typically feasible and frequently leads to extra work for the clinical staff.
Why is the “scanned paper approach” of using eSource completely wrong?
Recording data on paper and then scanning and uploading it to an “eSource platform” defeats the entire purpose of utilizing an eSource tool. In truth, eSource is supposed to capture the source data in an electronic form from the beginning, thus eliminating the need for any transcription.
Here are some of the downsides of using the “scanned paper approach”:
- Lack of data validation: The trial data that is scanned and uploaded into the system cannot be validated. For instance, consider a trial protocol that requires recording the body temperature of the trial subjects in Celsius. The staff records the temperature in Fahrenheit and scans this data into the system by mistake. There is no built-in validation system to identify this error and alert the staff.
- Inability to track protocol amendments and new ICF versions: Scanning physical paper leaves the research personnel at a severe disadvantage whenever a new protocol amendment or a new informed consent form (ICF) version gets released. This is because the paper documents that have already been scanned cannot be updated instantly, which is easily achieved with true eSource.
- Accidental enrollment of ineligible patients: Each trial protocol has many inclusion and exclusion criteria. Sometimes, some of these criteria may overlap between two or more studies. In such cases, it is not hard to imagine that one of the criteria, printed on a paper form, may be overlooked, resulting in the screening and randomization of ineligible patients for a particular trial.
- No way to cross-reference data: In true eSource, previously entered data is easily retrievable. The research staff can quickly search for prior, relevant data to catch any inconsistencies. However, this strategy won’t work with the “scanned paper approach,” as it is impossible to do an automatic search and cross-reference the data.
- Inability to use previous data to find potential trial subjects: eSource is a treasure trove of data that can be used to find suitable participants for future studies by performing an instant search. Using the “scanned paper” approach precludes the research team members from mining the previously entered data and, thus, from finding potential patients for upcoming trials.
In summary, eSource is an excellent tool for increasing the productivity and efficacy of clinical trial sites and producing much better data quality. However, to harness the full power of eSource, it is vital to understand the differences between eSource, EDC, and EHR and to steer clear of the “scanned paper” approach.
In future articles, we will delve deeper into the advantages of using true eSource. However, if you don’t want to wait and wish to know more about the revolutionary eSource solution developed by Clinical.ly and how it can help improve your site’s road to success, don’t hesitate to contact us and schedule a demo today.
