Is your site eSource-ready? 5 key assessment questions

As we’ve mentioned before, eSource is a term that can often mean different things to different people. At its most basic level, eSource refers to source data for clinical trials that is captured electronically. Beyond that, when people talk about the exciting potential that eSource opens up, they may be referring to source data being captured electronically on forms designed for clinical trials (eCRFs); patient-reported outcome data captured electronically (such as via eCOAs or ePROs); data captured by devices such as wearables; data captured electronically from sources such as lab tests and ECG readings; or data captured electronically during the course of health care provision – via hospital or GP Electronic Health Record (EHR) systems. 

What eSource means to IgniteData

When we talk about eSource at IgniteData – and we do this a lot – we are usually talking about the final form on that list – the data that healthcare providers are already capturing daily on EHR systems in hospitals. eSource, to us, represents a powerful opportunity for the clinical research community to transform the way clinical trials are run, by re-using the data that healthcare providers are already capturing in the most efficient way.  With advances in the potential for interoperability between EHR and EDC (Electronic Data Capture systems) used by clinical trial sponsors, healthcare data that is captured electronically is now more powerful than ever. 

EHR-to-EDC

EHR-to-EDC – where data that is recorded digitally in a hospital EHR system is transferred directly into the EDC – is the form of eSource that is most exciting right now for those in the clinical trial space. With new standards being applied almost universally to data held in modern EHRs, researchers now have the capability to automatically and securely transfer patient data held in EHRs, straight to the EDC being used for a clinical trial, without having to manually transcribe that data (as has been the case in the past).  This interoperability between systems is exactly the capability that is being brought to life by our system-agnostic Virtual Research Assistant, Archer.  

The IgniteData definition of eSource-readiness

We work closely with hospitals that are looking to take advantage of eSource data to unlock these efficiencies, enhancing interoperability and outcomes. Our definition of eSource-readiness encompasses five key questions: 

1. Do you store data such as medication, vital signs and lab data in a structured format?

Structured data is one of the most crucial factors that allows for the re-use of healthcare data. It is data that is highly organised –and specific – with separate fields for different data elements. Typically, it is data that answers a specific question in a standardised way, for instance a result or measurement that is numeric or uses coded terminology.

Examples of healthcare data that are easily organised into a structured format include medications, laboratory data, and vital signs. Freeform text notes, even if captured electronically, are not ‘structured’ in the same way, because they aren’t highly organised and standardised, making them difficult to search and pull data from. Structured data is more easily searchable if you are aiming to transfer data from EHR-to-EDC.

2. Is data captured during patient visits recorded in the EHR?

Clinical trials are concerned with source data – i.e. the first capture of that data. For data to be classified as eSource, it needs to first be captured electronically, rather than first being captured on paper forms and notes, and then transcribed into the EHR system.

Data such as vital signs data is structured, captured routinely during the course of health care provision, and essential to a clinical trial’s dataset. Nevertheless, once upon a time, you’ll remember vital signs such as blood pressure being checked and handwritten onto a chart hanging at the end of the patient’s bed. For this data to be used in a clinical trial, it then had to be manually transcribed into the clinical trial system, with copies of the original ‘source’ data maintained for regulatory purposes.

With modern digital tools, hospital staff can enter results directly into a digital chart, or, indeed, monitoring devices can even feed data directly into the EHR. If this data is entered and stored in the EHR in a structured format, the data can easily be queried and transferred directly over to a clinical trial’s EDC (using a tool such as Archer). This allows for a much more streamlined process for the use of data in a clinical trial, as well as greatly reducing the need for storage of paper-based records. 

3. Is laboratory data recorded in the EHR?

The growing volume of lab data being created means that laboratory information management system (LIMS) manufacturers have increasingly focused on facilitating data exchange between LIMS and EHRs. Largely because of these improvements, it is increasingly the case that hospitals are able to transfer structured data directly from their LIMS to their EHR. Hospitals that ensure their lab data is transferred to, and available from, the EHR’s database can then make that data available for a clinical trial, with minimum effort from the staff involved in the trial. 

4. Which EHR are you running, and is it capable of running SMART on FHIR apps? (If not, is there another FHIR interface available?)

SMART on FHIR apps are the key technology breakthrough that allowed us to develop the first truly agnostic EHR-to-EDC software. A SMART on FHIR app provides an interface that allows for another system to connect to an EHR, and the protocols they use mean there is a standard format and location for the data being stored.  

SMART on FHIR is quickly becoming universal to modern EHR systems. In fact, in 2016, the 21st Century Cures Act required all new US-developed EHR systems to use a common language, (HL7 FHIR) and have an application programming interface (API) – (SMART on FHIR ) giving access to the data in the system. This paved the way for a new level of interoperability between different systems.  For example, Archer features turnkey integration with a number of modern EHRs, including Cerner, Epic and Allscripts, largely thanks to FHIR apps.  

Even where an EHR doesn’t offer built-in FHIR apps, an emerging trend is that some hospitals are creating data warehouses, bringing together data from multiple sources, including EHRs, electronic medical records (EMRs), lab databases, etc.  

5. Is data (e.g. labs) being accurately clinically coded using terminology such as SnomedCT and LOINC? 

Just as structured data is essential to being able to search a database for specific fields, clinically coded data is essential to ensuring that data is systematically and reliably recorded in the same way each time. Coding and classification allow clinical data such as patient problem lists and family, medical, and social histories, to be shared in a standardised format. The accurate use of a universal terminology such as SnomedCT or LOINC, means that clinical data is recorded in a standardised way, and can be easily and accurately mapped over to a clinical trial sponsor’s EDC system.  

In our experience, many hospitals that we work with are able to rapidly improve their clinical coding with an analysis of weak points and a concerted effort in priority areas. 

eSource-readiness in hospitals

Increasing numbers of hospitals are recognising the value of achieving eSource-readiness, so they can make their clinical trials more efficient, effective and accurate. As well as this, many recognise the potential improvements to patient care, as clinical data becomes more computable, organised and accessible.  

In the UK, forward-thinking hospitals like Royal Berkshire NHS Foundation Trust (RBFT) and University College London Hospitals (UCLH) have embraced SMART on FHIR technology, and its potential to enable them to transform the way they conduct clinical trials. Many more major hospitals in the UK have also made strides towards this form of eSource-readiness, and either have implemented SMART on FHIR apps, or have it in their roadmaps, as of 2022. This is a critical move for hospitals in the UK, if they are to keep up with advances that have been made to digitally-enabled clinical trials, most notably in the US. 

Are you new to IgniteData?

IgniteData is the company shaping the future of clinical trials. Through our innovative eClinical platform, Archer, we are enhancing interoperability between Electronic Health Records (EHR) and key research applications such as Electronic Data Capture (EDC). 

Unlock your EHR-to-EDC interoperability potential

For more information or advice on assessing your site’s eSource-readiness, you can contact our expert team, or get started now by answering a few short questions about your site’s current status.