What is eSource?
According to the FDA, eSource is defined as “data initially recorded in electronic format. They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.”
eSource is already widely used in clinical trials. Common examples of eSource include:
- Rater and patient reported outcomes (“electronic clinical outcome assessments”, or eCOA)
- Data from clinical instruments such as imaging equipment, ECG machines, or wearable devices
- Lab data from a Laboratory Information Management System (LIMS); or
- Electronic Informed Consent Forms (eICFs)
However, clinical research sites have historically not captured their source data in a sponsor-funded, electronic application. As a result, sponsors don’t have direct access to site source data, and therefore require that sites transcribe their source into the study’s Electronic Data Capture (“EDC”) system, which houses Electronic Case Report Forms (“eCRFs”). eCRFs are discrete and related datasets that often mirror site procedures. Typical examples of eCRFs include Demographics, Eligibility, Vitals, Urine Pregnancy Test, Physical Exam, Medical History, Concomitant Medications, Adverse Events, IP Accountability and Subject Status.
In this context – and for purposes of this blog post – eSource refers to the use of an electronic system to capture clinical trial site source data.
Why sites don’t use the EHR as the source data collection tool
Electronic Health Record (EHR) systems are designed for health care workflows, not clinical trial workflows. As a result, most sites do not utilize an EHR system to capture study-specific source data (see EHR vs. eSource: Why so many research sites don’t use EHR as the source data collection tool). The biggest obstacle is that EHR templates are usually not flexible enough to accommodate the needs of a trial. For instance, there is no concept of an “Adverse Event” in an EHR system – an “Adverse Event” is a protocol-specific concept that is highly contextual to the study.
Many sites still create paper worksheets using Microsoft Word or a word processing program. They translate the protocol requirements into worksheets, print out the worksheets on the day of the visit, and then complete them by hand.
How widespread is site eSource?
Site-based eSource is one of the fastest-growing categories of software in clinical research. CRIO is the leading site-based eSource provider and licenses its software directly to sites. Today, we estimate that 35% of US-based research sites have adopted eSource. The vast majority of these sites are using CRIO eSource. In fact, on some phase 3 trials, we see upwards of 50% of U.S. sites using CRIO eSource on the trial.
This adoption is especially concentrated among higher-performing, professional sites, including the emerging class of site networks. These networks, many of whom are backed by institutional investors, are using eSource to improve productivity and increase standardization (see our eBook “The Rise of the Clinical Trial Site Mega Network”). As these networks expand, so will eSource utilization.
Across the majority of indications, there are enough CRIO eSource sites to power an entire study.
So why can’t sites just enter data into the EDC?
The FDA has indicated that direct data entry into EDC is permissible. For instance, in the FDA DCT guidance, the FDA indicated that certain trial-related activities can be performed by local healthcare providers (HCPs): “If the local HCPs have access to the eCRF, they can enter trial-related data directly into the eCRFs” and “Remote trial personnel or local HCPs submitting trial data directly into the eCRF should be included in the sponsor’s list of authorized data originators.”
However, most EDC systems have major limitations that prevent them from being effective site-based eSource systems. Traditional EDC systems do not naturally follow site workflows, making contemporaneous data entry and intra-site collaboration extremely difficult. Moreover, there is usually significant additional data sites need to capture beyond what is traditionally in the eCRF–this data is often the workflow data that is specified in the protocol, such as how to collect the vitals, what type and how far back to collect medications, which body systems to include in a physical examination, or how IP accountability is to be calculated. Think of the protocol as a detailed instruction set – the sponsor wants to know the data that results at the end of each procedure, but the site needs to know what each step of the procedure is, and therefore the site needs more detailed questions and instructions in the template itself to be able to collect the data appropriately.
Is there a way for sponsors to leverage the benefits of eSource?
Yes! With CRIO’s Central eSource, sponsors can benefit from eSource across their entire study. Sponsors are able to specify a standard electronic source template and then send the Central eSource template to the sites on the study. With CRIO’s support, sites can configure the eSource template locally to reflect any additional SOPs they have as well as the additional data they need to collect to demonstrate protocol compliance and support their workflows. Then CRIO’s built-in EDC integration can be used to populate the sponsor’s EDC at the click of a button or the sponsor can opt to utilize CRIO’s Reviewer EDC for a fully seamless experience.
This provides several major benefits to sponsors:
- Providing a standard source template as a starting point provides consistent data collection across the entire study AND reduces the burden on sites who no longer have to generate their own source templates from scratch.
- Real time, fully remote access to source data allows for a substantial reduction in the amount of on-site monitoring time that is needed, potentially leading to significant savings.
- When coupled with either an EDC integration or the use of CRIO’s Reviewer EDC, you can not only reduce source data verification (SDV), but also substantially reduce the burden on sites by eliminating double entry of data.
In a current large phase 3 study utilizing CRIO Central eSource, the sponsor chose to provide sites the option of whether or not to use CRIO. Sites that are using CRIO have 90+% fewer queries than those sites that opted out.
What if I want to work with sites that are not already using CRIO eSource?
As a general rule, sites are free to use the electronic system of their choice to collect source data, so long as the system is 21CFR11 compliant, so sponsors normally do not dictate how sites collect their source data.
CRIO’s experience is that most sites will opt to use the system when given a choice. Since CRIO eSource was built for sites, the sponsor has assurance that its workflows will be intuitive to new sites. In fact, many sites that had not previously used CRIO end up adopting it for the rest of their studies after opting in as part of a Central eSource study. With a baseline level of native site adoption ranging from 15-50% on any given study, final site adoption, when offered and encouraged by the sponsor, can easily exceed 50%.
Interested in learning more? Contact us to find out if your next study would benefit from Central eSource.