As I write this, I’m on a return flight home to Philadelphia from Las Vegas where I attended the Annual SCDM conference. It was a great event and I’m pretty revved up to share what I saw and heard there, especially on the evolving topic of eSource.
One session I’d like to tell you about is an eSource roundtable that was moderated by Linda King, Director of Global Data Delivery at Eli Lilly and Demetris Zambas, VP and Global Head, Data Management at Novartis. Representatives from CDISC, Merck, J&J, AssisTek, Quintiles, and Otsuka rounded out the expert panel.
SCDM eSource Principles White Paper
To start everyone out on the same page, we began by exploring the 7 eSource Principles outlined in SCDM’s white paper, eSource Implementation in Clinical Research: A Data Management Perspective, published in June 2014.
As a quick review, the principles are:
- Use solutions “fit for purpose”
- Declare the source
- Capture data when first generated
- Control electronic data
- Leverage automated quality checks
- Control for quality
- Conform to regulations and guidelines
Such a great resource for anyone interested in learning more, I recommend downloading SCDM’s FREE white paper available at the above link. In a future blog to be posted soon, we’ll explore how these 7 principles are deployed, but for now, let’s delve into where SCDM attendees say they stand with eSource.
eSource Definition and Modalities
Most everyone I’ve heard weigh in on the subject say they see the value of eSource, yet many express uncertainty as what to do next. Demetris Zambas conducted an informal audience poll during our session that was quite revealing. A show-of-hands indicated that only 10% of the 100+ attendees say they are using eSource. By comparison, when he asked who uses central labs, a whopping 90% shot up their hands. So why the disparity?
What seems to have clouded the picture here is how some people view eSource. To illustrate, let’s review the definition of eSource as it appears in the FDA Guidance for Industry: Electronic Source Data in Clinical Investigations. The agency’s definition is short and simple:
- Electronic source data are data initially recorded in electronic format.
Keeping this definition in mind, let’s turn to central lab data. What is it? Central lab data is data that is directly entered from a source (typically blood analyzers) into the clinical trial database. It is a type of eSource data!
That quick, little poll shows there is some confusion surrounding the definition of eSource and the modalities used. I continually come across folks in my own discussions who still equate eSource with taking data traditionally collected using paper sources and replacing it with direct entry into an electronic source.
Actually, eSource is so much more than that. It covers a range of modalities, including third-party generated data sources such as central laboratories, ECG data, and IRT. All of these are eSource and in fact were among the first electronic sources to be adopted as pointed out in the SCDM white paper on eSource implementation. In addition to third-party data, eCOA, EDC and EHRs are among the list of most common eSource data collection modalities used today.
To add some real-world perspective to this discussion, consider this: Here at BioClinica we currently have sponsors exclusively using eSource and successfully running hundreds of clinical studies.
I have so much more to share with you from the conference and other meetings, but I’m short on time as a dip in elevation signals I’m close to home. Come back and read my upcoming blog post on topics to include eSource challenges (which are more easily overcome than you may think). We’ll also look at what sites REALLY want in eSource and how to handle EMR data. We’ll also look at what I call a data source hybrid, which just may prove to be the key to taking eSource to the next level in your own programs.
So drop me a line and let me know how you are using, or NOT using, eSource. Oh! And catch me live in a webinar I’m doing on CDISC standards in November. I’d love to have you join me.