Data operations in clinical trials are most effective when entrusted to experts. Clinical data managers, biostatisticians, and versed medical writers ensure that all trial data is adequately collected, stored, analyzed, and presented. However, the initial of the data processes is not in their domain – data entry.
Patient data is entered at the site by the operating staff. Now, considering the amount of entered data in an average trial, the integrity of the data is often challenged.
Sourcing of data is one of the essential operations in clinical trials. However, it is infused with data discrepancies, which can seriously affect the outcome of a trial.
What Is Data Source in Clinical Trials?
Initial data within a clinical trial or “source” data is the data acquired from the central element of the study.
The “source” is the original document of a patient enrolled in a trial. Examples of source data include visit-based data inputs, such as blood pressure recordings, height, weight, BMI, concomitant medication, as well as other study-specific data.
In usual settings, paper-based evidence is used and later on transferred to a computer. In other words, the data is sourced manually, and further on captured to a distanced electronic device and fed to an online database.
The process of repeated data entry usually creates additional costs on staffing, and the multiple inputs can compromise data integrity. This creates the need for source data verification process, which by itself is costly and time-intensive.
The complexity of paper-based monitoring on a global scale imposes another challenge of shipping capture forms overseas and accompanying costs of numerous paper prints.
A solution lies in technology – sourcing data right there on the spot without any unnecessary paperwork.
What Is eSource?
eSource is the digitized process of capturing data on-the-spot, which eliminates duplicate entry while reducing errors at the same time. The modern technology solutions promote real-time entry of electronic source data during subject visits, thus reassuring for completeness and accuracy of entered data.
eSource increases the compliance levels of all parties by reducing redundant tasks while at the same time enabling remote monitoring. Platforms that allow eSource facilitate faster input of more precise data, perfect real-time data synchronization, and reduce query resolution costs.
The core benefits of using eSource-enabled software include:
- Eliminating low-level manual data entry and unnecessary paperwork
- Ensuring data integrity and improving data accuracy
- Eliminating duplication of data
- Promoting real-time monitoring of data entry and storage
- Ensuring detailed compliance data in a patient’s case report form
- Facilitation of better trial communication
- Lowering costs on staffing and source data verification processes
However, for full compliance, the users of the technology in healthcare facilities need to integrate eSource applications with their EHR systems.
The Difference Between Classical EDC and eSource
Although they are both designed for recording source data in a trial, there is a slight difference between the two.
The classical use of EDC is widespread in clinical trials. However, the EDC templates can be filled at any time. Usually, trial operators or Clinical Research Associates can capture the data after the patient is gone or retype them from EHRs during scheduled visits. This delayed or double EDC feed often leaves room for errors.
On the other hand, eSource is a technology designed for clinical trial operators to be used by participating physicians at the moment of examination, thus inputting more valuable compliance-related information from the patient.
eSource: Reality or Future
Regardless of the contemporary technological development, most of the clinical trials are still conducted using paper-based case report forms.
However, the global healthcare crisis caused by the COVID pandemic has imposed an imperative to eliminate all unnecessary operations in clinics, which significantly impacted the execution of current clinical trials.
Now, we are experiencing a significant shift in trends regarding everyday clinical work, favoring the use of eSource in data acquisition for clinical trials. Using of eSource technology enables clinical staff to utilize their time on what they do best – care for patients.
It is time to embrace these trends. Implementing eSource is not a thing of the future anymore, but an objective reality.