Dec11

Understanding E-Source in Clinical Trials: What You Need to Know

Within the clinical research community, “e-source” is a term that’s receiving quite a lot of buzz – and for good reason. In an age when 21 CFR Part 11 compliance is more important than ever, organizations are clamoring to acquire electronic source data capture solutions and vendors are increasingly adding it to their list of solutions. While this new solution is indeed promising for the future of clinical research, there are many misconceptions surrounding e-source that undoubtedly need to be addressed. This blog post intends to define e-source within the context of clinical trials, discuss the benefits of e-source and how health organizations can best utilize this relatively new clinical trial solution.

Defining E-Source

Affording to the Food and Drug Administration (FDA), source documentation is the initial documentation of data within a clinical study; the “source” being the original element within a clinical trial. Examples of source data include initial blood pressure recordings, height and weight charts, etc. From there, integrity is then maintained by using an audit trail to track any changes or modifications that may occur throughout the clinical trial process.

E-source is the digitization of this source data capture process. Instead of recording source data manually then later transferring this data to an online data base, e-source captures data electronically off the bat; all source data must be electronic and must be followed with a detailed audit trail.

There are many benefits of utilizing e-source solutions, which include: 

  • Eliminating the unnecessary duplication of data
  • Reducing the opportunity for error
  • Promoting real-time entry of electric source data during subject visits
  • Ensuring accuracy and completeness of data

Common Misconceptions Surrounding E-Source Solutions

While these benefits prove to be tremendously valuable for clinical trials, there are key attributes of e-source that clinical research organizations need to understand in order to leverage the true value of this solution:

The nature of e-source compliance

While it is widely recognized that e-source is 21 CFR Part 11 compliant, users are not often clear on Part 11 compliance and what it demands from users and vendors respectively.

Integration compatibility

Clinics investing in e-source need to make sure they are able to integrate e-source into their current backend system, typically a CMS. If this integration does not take place, sites will be subject to the risks and errors that come with duplicate data entry.

E-source and CTMS do not meet the same needs

While CTMS and e-source both contribute to the accuracy, efficiency and compliance of clinical trials, these solutions are NOT the same thing. CTMS software does not handle source data, and does not require Part 11 compliance.

Conclusions and Recommendations

When leveraged and utilized properly, e-source is a solution that saves time, money, and leaves little room for error. That being said, it’s worth considering for your clinical research trials. However, it’s important to note that while worth investigating, this is a relatively new solution – there’s no need to rush in adopting e-source! Instead, we recommend taking time to learn about what’s about on the market and which e-source product is best for you:

  • Talk to your current technology vendors; ask for their thoughts on the topic and if they plan to integrate with an existing solution
  • Ask detailed questions to e-source vendors (How are they compliant? What risks did the site take when utilizing the software?)
  • Look for best-in-class partnerships and integrations – this is how you can tell one has a unique competitive advantage.

While CTMS does not handle source data currently, Bio-Optronics, we are dedicated to researching and innovating solutions that maximize efficiency, quality and consistency for healthcare organizations around the world. Contact us today to learn more!

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