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The four types of eSource

Written by Jon Carter, Product Manager, 23 Dec 2019

eSource means different things to different people. You may have never even heard of it, so this is the first in a series of posts which aim to unlock what eSource is.

When I ask “What does eSource mean to you?”, I receive many different answers, and quite often they weren’t what I had expected.

Perhaps we should start by reminding ourselves of the current method for collecting and managing data in clinical trials. Most trials use EDC (Electronic Data Capture), where data is collected elsewhere, then transcribed into an EDC system. That data could be initially collected on paper source, or electronically into a site’s EHR system.

“Doing eSource” is a mixture of removing the need for paper source, and also utilizing the data that is already collected and stored electronically. This means we can split eSource into four different categories. Over the course of the next few posts, we will look into each of these categories in some detail.

These four categories boil down to:

Direct Data Capture: Where data is entered directly into the eCRF instead of onto paper or into the site’s EHR.

Electronic Health Records: Many sites already collect lots of data in their EHR system, so can we pull this data directly into the eCRF or EDC system rather than through manual transcription.

Devices and Apps: Electronic source data is also collected from eCOA/ePRO, eConsent, wearable sensors etc.

Non-CRF: Data from other sources, such as Central Labs, Imaging, ECG

What I’m trying to convey is that there is not a single eSource type or system. There are vendors who may market their systems as offering eSource capability, but they typically only mean eSource as Direct Data Capture. But Direct Data Capture is not a full eSource solution. For example, when entering a patient’s medical history into the eCRF, it must have been transcribed from source elsewhere. What if we could automate and utilize the electronic source of THAT data as well?

Imagine the benefits of being able to manage all data, from all sources, together in one system? We believe encapsia is the answer.

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The global COVID-19 crisis has fundamentally impacted the way we live our lives as well as the operation of the entire drug development community. As the crisis continues to evolve, the Cmed leadership team has already implemented a number of measures to ensure the safety of our employees, clients and partners, as well as ensuring the continued delivery of our CRO services and our encapsia clinical data system. Our goal being to minimise the impact of COVID-19 on our business, our clients, investigator sites and patients.
Thank you for your continued loyalty and trust in Cmed and encapsia during these uncertain times. We are continuously monitoring the evolving circumstances surrounding the COVID-19 outbreak and continue to operate as normal. ~ Our highest priority is to maintain the health and safety of our people, customers, partners and suppliers while meeting our service commitments. Cmed has implemented a range of measures in line with World Health Organization guidance to minimise the risks for employees and customers.
Direct Data Capture (DDC) is one of the four types of eSource (see previous post), and is often what people first think of as eSource. Direct data capture is the process of entering data into the eCRF contemporaneously, rather than transcribing from other sources such as paper or site EHR systems. Some technology providers believe that EDC systems can be used as eSource, where the web based EDC system is carried around on a laptop, or potentially a tablet, and data is entered directly into this system.