See Up to 65% Time Savings with eSource Data Collection Methodology
Overview
As technology solutions are increasing in adoption in the clinical research industry, ways to maximize their efficiencies are being more closely considered. eSource is emerging as a possible process to remove complexities and deliver time and cost savings to studies.
In eSource studies, data is entered directly into an electronic data capture system (EDC). In comparison, paper-sourced studies record the data first on paper and later the contents are transcribed into the EDC solution. Fountayn completed the comparison of both approaches and saw time savings of up to 65% when utilizing eSource methodology. Companies are turning to eSource studies when looking for a cost-effective way to run trials when preserving data integrity. Additionally, benefits of eSource studies include the ability to remote monitor real-time data and the reduction of central monitoring costs, which are in addition to the noted time savings.
Benefits of eSource Studies
As with the introduction of EDC, the use of eSource has the potential to positively impact time and cost requirements for data entry and management. These benefits (as defined by the FDA in the Guidance for Industry Electronic Source Data in Clinical investigations - September 2013) include but are not limited to:
Eliminate Unnecessary Duplication of Data
Reduce the possibility for Transcription Errors
Encourage entering source data during a subject’s visit, where appropriate
Eliminate Transcription of source data prior to entry into an eCRF
Facilitate remote monitoring of data
Promote real-time access for data review
Facilitate the collection of accurate and complete data
Similar benefits were seen in the three additional studies supported by Fountayn and described below. All of the benefits anticipated by the FDA as listed above were realized in these three studies. All of the studies eliminated unnecessary duplication of data as well as reduced the queries typically generated to confirm entries commonly queried due to transcription errors. One of the key benefits of employing an eSource approach to data collection is the increase in data quality upon entry. This benefit was demonstrated with the overall reduction in the need to query as well as the reduction in the number of entry errors based upon protocol-specific system checks and study focused programmed quality checks.
An additional benefit of eSource found in all studies is accessibility to study data at the time of each patient visit. As part of a comprehensive and coordinated workflow process, site personnel needed to enter data at the time of patient visit - essentially validating the methodology associated with the employment of an eSource strategy. The resulting higher quality data at the point of entry confirmed the potential benefits to be gained through the use of an eSource approach.
Benefits:
Higher Data Integrity
Decreased Review Time
Why Companies Still use Paper Source
There is a certain comfort in paper-sourced studies that motivates companies to keep using them despite their costliness and inefficiency. There is an established workflow process in EDC for paper-source studies.
The Process is:
The site writes down data on a source document and then enters information into the system.
The monitor reviews subject data against source documents and verifies data for all subjects at their site(s).
Once data has an SDV status, it signals that the monitor has reviewed the data against the source and data management can begin their review.
With eSource trials, the traceability of the workflow between monitors and data management within EDC is less concrete. With a thoughtful approach, the updated workflows within EDC systems can be created and become the new ‘norm’, delivering time and cost savings by removing the complexities of paper-based sources.
There are industry standards in paper-sourced trials, including guidelines on how to correct errors on source documents, the monitor/data management workflow process within EDC and the SDV process. The lack of standardization in eSource studies causes companies a certain level of discomfort regarding the process to implement FDA guidance. But these issues are easily overcome and create a foundation for additional time and cost savings for future eSource studies as trial professionals become more familiar with the process.
Figure 1
Challenges of eSource Studies
Workflow Process - The workflow process between monitoring and data management was a challenge in all three studies. At issue was the mechanism to document data review by monitors and data management within the EDC system. Typically, the monitor’s review of paper-source study is indicated by marking a page, visit or subject as SDV. In an eSource trial, there are no documents to mark, so a new procedure had to be put in place to track the monitors’ review; the addition of data review flags.
In the studies considered here, the first two used the ‘Answer Status’ data review flag in the system to track monitored data and signify to data management that the subject had been reviewed. Study 3 used ‘Answer Status’ and ‘SDV Status’, both data review flags, to signify the subject had been reviewed as this study did contain a number of source documents. Leveraging existing tools in the EDC solution, specifically the data review flags, provided the workflow process solution. All trials were successful in the implementation of these tools.
Protocol-Specific Systems Checks - Protocol-specific system checks were defined in the study startup phase.
Since sites were entering data directly into the system and no source documents were being used for data collection, a mechanism was needed to ensure the coordinator was aware of protocol-specific specifications and inclusion/exclusion criteria. Additional edit checks were added during the startup phase to ensure higher data integrity and verify subjects that didn’t meet criteria were not randomized. However, the additional edit checks in the EDC system became cumbersome for sites to answer upon data entry.
Study 1 had an excess of edit checks programmed; the study team retroactively turned off unnecessary edit checks in the system. Study 2 and Study 3 streamlined the study startup process by identifying the integral protocol-specific checks. eCRF check pages, like those for prohibited medications, and notes were used to supplement the edit checks that had been programmed in the system. Identifying protocol-specific system checks during the custom edit check specification process allowed for higher data integrity due to alerts firing upon real-time data entry into the system and notifying site staff to potential data problems.
Data Originator Elements - FDA guidelines pertaining to data originator elements for transcribed assessments appeared as a challenge in Study 3. To better explain the issue, understanding the context is essential. Specific assessments for the eSource studies were authorized to be conducted by the Principal Investigator (PI). However, the coordinator was entering the results into EDC. According to the data originator log, these specific assessments were only authorized for PI’s to conduct and enter in EDC and not authorized for the coordinator. For these specific transcribed assessments, the coordinator was displaying as the data originator for the data points associated with the assessment within EDC, although not authorized. There was a need to indicate that the authorized data originator had reviewed the transcribed data and to verify the data was correctly entered by the coordinator.
Site Compliance - Site compliance with FDA guidance of electronic source data was a challenge in Study 1. Site were writing down study-related information on paper; therefore, the paper became a source document. The solution required monitors to re-train the site regarding the use of paper in the study and emphasize that paper sources were not allowed for eSource studies. In addition, a note-to-file (NTF) was created for the specific site documenting the paper sources.
Challenges:
Workflow Process
Data Originator Elements
Protocol-Specific System Checks
Site Compliance
Future of eSource
The future of eSource is quickly evolving, as familiarity with eClinical solutions and a focus on optimizing their implementation are pursued.
Familiarity and optimization of start-up and workflow process are essential considerations for the future of eSource studies. Learning form the deployment of Study 1, Studies 2 and 3 gained efficiencies in process; these studies experienced streamlined study deployment timelines, distinct data review responsibilities for data managers and monitors, decreased user error. Working within the confines of the EDC system, solutions were created to address obstacles associated with the implementation of eSource studies. But to be successful, your EDC solution must provide flexibility and easy configurability to optimize the potential time and cost savings. Using Fountayn EDC, the study startup process for all three studies was easily modified to support eSource studies, optimized for subsequent deployments and standardized for future use.
A thoughtful approach that focuses on leveraging the power of the EDC solution can minimize the challenges of the transition to eSource studies, creating new opportunities to safely accelerate clinical research.
*Fountayn Formerly known as Datatrak