6 Benefits of Switching to eSource

You've been working with physical records for some time - but you're thinking about making the switch within your organisation. Clinical trials involve quick decisions and efficient run-time. If you're at clinic, you will probably have a fixed amount of time to spend with participants and a checklist of activities which need to get completed before you move onto the next. Any delays could pose large risks to getting what you need to complete the study. In this post we will cover some of the major offerings eSource can provide. These include:

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• Data Accuracy and Quality
• Time and Cost Efficiency
• Remote Monitoring and Accessibility
• Real-time Data Visibility
• Regulatory Compliance
• Patient Engagement and Experience

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First things first: What is eSource?

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An electronic source (eSource) refers to the electronic version of source data in clinical trials, replacing traditional paper-based methods of data collection and documentation. It encompasses various electronic systems and devices used to capture, record, and manage clinical trial data directly at the point of origin. This can include electronic health records (EHRs), electronic case report forms (eCRFs), smartphone apps, wearable devices, and other digital platforms. eSource helps streamline data collection processes, enhances data accuracy and integrity, improves data accessibility for monitoring and analysis, and facilitates real-time data review and query resolution. By eliminating the need for manual transcription and reducing data entry errors, eSource contributes to more efficient and reliable clinical trial conduct, ultimately accelerating the drug development process and improving patient outcomes. By its very definition, eSource means “source”. Therefore it should be treated as original source documentation in a similar manner to paper or other physical records.

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Data Accuracy and Quality

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If you are familiar with our Data Collection Nightmares series, you will have seen some very real-world examples of how data accuracy and quality have been impacted upon by paper records. There are just too many variables with hand-written records. Hand-writing styles, ink colours, literacy of the signee, the openness of writing anything your hand desires (no validation). eSource removes all these concerns when implemented, and validated fields ensure that your data is correct.

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Time and Cost Efficiency

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If you're using pen and paper, your records will probably be digitised to some extent anyway. Whether this is entering into a spreadsheet or word processing document, or even making copies by Fax/scans for digital storage. Why create unnecessary additional steps? with eSource, you are digitised from the get-go, saving you time on staff costs. What's more, time saved can be re-allocated elsewhere. Perhaps increasing the enrolment number in your study since your workforce can handle larger volumes of participants?

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Remote Monitoring and Accessibility

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Your study will involve a number of key stakeholders. They might be collaborators, sponsors or various project management oversight. eSource platforms provide a lot of interesting functionality these days, including the ability for oversight of where participants are in the process. How far are you through enrolment? How many participants have completed their first visit? Are there adverse events - how many? Has compliance significantly dropped after a certain point in time? A good eSource setup will enable these questions to be answered and visualised quickly. If you have international colleagues, use this to your advantage to communicate more effectively and prevent the need to meet up in person, or to organise video calls over multiple time zones.

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Real-time Data Visibility

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Elaborating on the previous point, real-time data is an absolute must. In longitudinal studies where critical decision-making might be required, you will want your key stakeholders to be fully aware of the study status, metrics and current outcomes before committing to decisions which will affect the fate of the trial. An example of this might include safety data. If adverse events are increased in one arm of the study, despite being blinded, this could suggest that the study needs to end, or, that doses of an intervention are not as safe as first anticipated. Useful visuals which compile this data are essential in upholding participant safety in this context. Where pen and paper records are used, compiling this - often with a statistician or data scientist - can take time. Time you might not have when participants might be at risk of harm.

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Regulatory Compliance

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One of the staples of Good Clinical Practice (GCP) which we have covered in other posts are the principles of ALCOAC, These are: Attributable, Legible, Contemporaneous, Original, Accurate and Complete. Clinical guidelines set out by regulatory bodies including the Food and Drug Administration (FDA), Medical Health Research Authority (MHRA) and European Medicines Agency (EMA) will require that these points are followed quite tightly. In the case of 21 CFR Part 312 onwards, the FDA outlines how various responsibilities, including ALCOAC, should be upheld by the sponsor and investigator as part of study conduct and close upon completion.

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Patient Engagement and Experience

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Outside of clinic, eSource of records entered by participants themselves (for example by patient/participant-reported outcomes) can also be incredibly useful. With less control over user input with paper forms off-site, put simply, you don't quite know what you will get back from participants. There can be sufficient guidance which has been tried and tested as part of your protocol and study design, but paper forms in the hands of users at home can take unexpected turns. eSource in a controlled and validated system will prevent - or at least in part - minimise these risks.

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There is a lot to consider when switching to eSource but as the industry moves more into this space, software and technologies are becoming available that have already done the hard work for you. They've been worked on, optimised, co-developed and updated in-line with best practices to make your teams work much easier and compliant.