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eSource as Direct Data Capture

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. The big problem is that such EDC systems are designed for the sponsor and don’t take into account site preferences or workflow.

At Cmed Technology we have a purpose-built eSource app, to work on tablets and specifically designed for sites. While there are similarities to an EDC system there are subtle but important differences. For example, we designed the encapsia eSource app not only to collect sponsor required CRF data, but also the process data required by sites. In addition, sites can use the tablet’s camera and microphone to attach additional notes and multimedia records. The app enables fast data entry with an intuitive user interface that behaves like the apps we all use in our daily lives. On top of this, the encapsia Direct Data Capture App works seamlessly offline, allowing sites with varying internet connectivity to enjoy an uninterrupted experience.

When selecting a direct data capture system for your study, you may also want to consider the study phase or therapeutic area. I’ve had the pleasure of witnessing dosing days at Phase 1 sites, where the whole site is a buzz of well-drilled activity, with multiple people running from one patient to another, diligently carrying out their tasks within very specific time frames. The eSource system chosen must not obstruct data collection at such intense times.

Direct data capture brings along many benefits. Including:

  • Data being available at time of collection
  • Zero transcription errors that are typically associated with EDC
  • Improved data quality, as validation checks fire in real time
  • Reduced monitoring with no need for source data verification
  • Clinicians prefer to work with a system designed for sites, not sponsors

But there are also some challenges to overcome:

  • Site resistance - a new system may not fit quickly into the processes perfected by sites over several years.
  • Site training - nearly all users at site require training, unlike a handful of users that would be trained for EDC.
  • Logistics - sourcing and managing tablets across lots of users.

Our experience

We have reached out to site users to gather feedback on their experience with the encapsia eSource app. The results were

  • eSource with encapsia is easy to use
  • The system enables users to make real time data corrections as queries opened at the time of data collection
  • Users appreciate the offline functionality
  • Overall the system shortened data entry time

But, there was….

  • A learning curve for a new type of system
  • A need for site subject matter experts, who were experts in the technology

Direct Data Capture definitely has a place in the eSource world, but it’s not the complete story. Some data is collected electronically elsewhere, which either requires transcription or the ability to integrate all types of electronic source into one system.

eSource as Direct Data Capture

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