Electronic source (eSource) refers to the collection of source data entered directly into an electronic system with the intent to produce high-quality data at a faster rate. eSource helps remove the need to maintain paper source and simplifies data collection. With the increase in trial complexity and the proliferation of technology in the clinical research industry, the adoption of eSource has become an essential part of the modernization of clinical trials.
In the previous post, we clarified several misconceptions associated with eSource, including the “scanned paper approach,” amongst others. This article will discuss the upsides of utilizing eSource and the value you should expect from adopting “true eSource.” We will also briefly review the recommendations provided by the FDA and the EMA regarding the use of eSource in clinical trials.
Advantages of utilizing eSource
The true purpose of eSource is to capture source data directly in a digital format, thus, leveraging technology to accelerate data capture (e.g., reducing visit times!) while simultaneously reducing human error and providing a double-check during data entry. Below are some of the advantages of utilizing eSource in a clinical trial:
- Reduced complexity – eSource provides the ability to conditionally display relevant data collection questions and hide irrelevant or not-applicable questions and procedures. Using this approach, you can ensure that all the relevant study data is collected while simultaneously avoiding costly and unnecessary procedures for collecting irrelevant data.
- Built-in data validation – The automatic data validation of the eSource system helps avoid data entry errors and serves as guardrails to prevent fat-fingering, which, in turn, increases the accuracy and reliability of study data while reducing queries.
- Automated protocol amendments – When the protocol amendments come in, the study staff must ensure they update all source documents for upcoming study visits in accordance with the latest protocol version. This is particularly difficult in trials with a large number of volunteers using paper source documents, as the protocol versions may get missed for some of the many volunteers. eSource provides a simple solution for this issue, as changing the data in one place results in updating source for all upcoming study visits, thereby ensuring that the latest protocol is followed for all study visits.
- Customizable permissions – eSource can be used to customize which study personnel may see or answer certain data collection questions. For instance, masked personnel would not have access to unmasked data and vice versa. In this way, complete adherence to the protocol requirements is ensured.
- Increased data entry speed – When a study coordinator enters data directly into eSource, rather than onto paper, the time-consuming step of transcribing data from paper source documents is eliminated. Additionally, defaults, conditional logic, and automated selectors available in the eSource platform help accelerate the data collection process.
- Easily searchable answers – Searching for clinical trial volunteers requires a lot of time and effort and often involves conducting surveys and asking patients to complete different questionnaires. If this data is stored in eSource, it becomes incredibly straightforward to search for answers to previously asked questions, enabling you to more easily find volunteers for future studies.
- Ease of remote monitoring – eSource can automatically redact protected health information (PHI) from the study patient’s data. Following redaction, the data is ready for sharing with study monitors, who can review it remotely based on their specific permissions.
- No need to store paper – In the past, we discussed the hidden costs of using paper documents in clinical trials. eSource is incredibly valuable in lowering these hidden costs, as it eliminates the need to use paper and thus, reduces the financial burden, storage space requirements, and risk of losing invaluable work.
FDA and EMA guidance on the use of eSource
In 2013, the United States Food and Drug Administration (FDA) released a guidance document to assist clinical trial sponsors, contract research organizations (CROs), investigators, and other stakeholders involved in collecting electronic source data in clinical trials. This guidance includes information on the use of computerized systems in clinical trials, different ways to capture eSource data, identification of source data originators, and creation of data element identifiers to help examine the audit trail. This FDA document emphasizes that the requirements of collecting clinical trial data using a computer-based approach are not much different than those of a paper-based process. Keep in mind that appropriate controls should be implemented to ensure that the eSource data is trustworthy, accurate, complete, and protected.
The European Medicines Agency (EMA) also recently issued a qualification opinion on the use of eSource data in clinical trials. This opinion signals EMA’s favorable view toward using eSource in clinical trials and discusses the characteristics of an ideal system used for collecting eSource data. According to this document, an eSource data capture system should be validated, tested, secure, and maintained and must be customized in accordance with local legal requirements and with the International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines. EMA is developing a Guideline on Computerized Systems and Electronic Data in Clinical Trials that is currently in the draft stage.
eSource is a powerful tool, and the utilization of eSource in clinical trials can help optimize clinical research by improving data integrity and enabling faster access to research data. The release of guidance documents by the two largest drug regulatory agencies indicates a strong consensus among these agencies on the potential benefits of eSource for multiple stakeholders involved in clinical research.
Clinical.ly is deeply invested in the future of efficient clinical research and is always striving to create technological solutions that benefit the clinical trial industry. To harness the true power of eSource, we developed an eSource solution that is secure, accurate, reliable, easily customizable, and in line with major regulatory agencies’ requirements. To learn more about our intelligent eSource solution, please get in touch with us and schedule a consultation today.