Why eSource: The Advantages of Abandoning Paper Records
The justification for designing eSource trials is in the advantages they provide in reliability across most human tasks that interface with a clinical trial database. In short, eSource as a strategy eliminates a broad spectrum of potential transcription errors in addition to fully leveraging the supporting eClinical technology to provide reliable consistent exchange of information.
Improve Data Quality
Real-time capture of data within the EDC, means that the entire process of transcribing records from paper source documents into an electronic system is completely removed from the equation. Any individual instance of human transcription introduces the possibility of error, and is a primary consumer of monitoring time.
Having source data entered directly into an EDC platform also allows the team to take full advantage of the system’s ability to automatically validate data. Programmed edit checks allow investigators to identify issues with data at the point of entry, rather than days or weeks after it is initially collected. Query resolution can occur immediately. The general cycle time of all data cleaning and data management activities can be drastically reduced by moving the entire process to a system that collects and shares information in real-time.
Reduce Costs
At sites, eSource can represent cost savings by eliminating the need to store vast quantities of physical documents on site. It offers significant time saving in hours spent transcribing documents, or scanning paper records after a patient visit. With eSource this data can be captured once, in the location that it is to be analyzed.
A natural result of reducing transcription in a clinical trial and its associated data quality issues is there are fewer data quality issues to be addressed by monitors. The cost of monitoring activities in general can be reduced by empowering a smaller team to conduct remote monitoring visits. With all clinical source data residing on the EDC, ideally cleanly connected to a robust CTMS, these personnel have all the information they need in one place to complete a site visit from their personal computer.
Eliminating the traditional need for travel in monitoring activities also opens up the possibility of conducting international trials with a much broader scope of involved countries. Real-time access to source data allows for patient recruitment across a much larger population, improving patient recruitment, reducing the cost of enrollment, and improving the inclusiveness of clinical research as a whole. It promotes real-time data reviews and allows for strategies, like true Risk-Based Monitoring (another topic entirely, and potentially disruptive cost-saver).
Improve Regulatory Compliance
Regulatory support for eSource practices is growing steadily, and the major institutions in the US and UK have issued guidance outlining their support and encouragement for these strategies. Check out our previous blog post, “Regulatory Support for eSource” for a more detailed outline of these considerations and requirements.
Having all source data housed in an electronic system provides powerful advantages in terms of traceability through well-documented audit logs, and availability of key information to all members of the team. It confers consistent, high levels of security to all data housed within the electronic platform, offering the best protections to sensitive patient information. It also speeds up interaction with regulatory authorities by making the demonstration of compliance much simpler. Everything needed is found in one place in a highly reportable format.
The data quality advantages of eSource trials already discussed at length, of course also reduce the incidence of regulatory findings.
Lastly, patient engagement and compliance with the protocol can be improved. This is also a key point of regulatory approval. A patient’s engagement with a trial has less oversight and fewer enforcement mechanisms. Tools like ePRO and eConsent bring the data capture process directly to the patient, and optimize for the patient’s experience in the trial. A demonstrable focus on the patient’s experience, less drop off, and better compliance with the study protocol are all factors that will be favorably reviewed by regulatory authorities.
If you’ve read this far, I encourage you to take a look at the original guidance document from the FDA. Eliminating or reducing processes in your trials that involve paper documentation can represent profound efficiencies in the space of data management and monitoring. If you’d like to speak with us about how we can support paperless or hybrid trials shoot us a message today or let us know your questions.