An open source Elelctronic Data Capture (EDC) system? Really?

Back in 2004, when I would tell people about our open source electronic data capture (EDC) technology and our open source business model, I got a lot of crazy looks and confused reactions.

Fortunately, these days there is a much greater understanding in our industry of what open source software is and for the significance of its ability to solve core problems that proprietary software cannot. However, we still have to try very hard to make sure our users understand what is different about open source and what they should expect. Over the course of my next few posts I’ll explore some aspects of how open source matters in clinical research informatics. Some of the ideas I’ll be exploring include (note this list may change, don’t hold me to it):

  • Validation and Compliance
  • Security
  • Support and reliability
  • Customization
  • Cost

4 thoughts on “An open source Elelctronic Data Capture (EDC) system? Really?

  1. Looking forward to the posts. Just wanted to mention my experience in introducing OC (we’re not using it yet, but I hope to) to my department – the main concern/misunderstanding is that my colleagues (not “computer people”) assume that open source:
    1) isn’t really free
    2) isn’t compliant
    3) isn’t secure
    Once I get past all that, the one thing that I repeatedly have to explain is that we hold, and own the data. I guess in the past when given something for free, they’ve had to give up the rights to the data and it would be held elsewhere. That’s repeatedly their main concern – ownership of the data.

    Hopefully I can print out your upcoming posts.

  2. Hello Cal,

    I’m very intrigued with where open source in this space is going… Although I haven’t really dug into OpenClinica, I’ve been following progress relatively closely.

    There is a point that I’d like to add to your list (no – I’m not holding you to it 🙂 Each bullet point that you’ve made is great, but I think it’s really important to understand the paradigm from which the points are viewed. For example, the FDA and a drug sponsor will approach validation and compliance in a very different fashion.

    From what I’ve seen, regulators may be more willing to adopt an open initiative (especially when it facilitates meeting a standard [CDISC, SDTM, etc]) than a sponsor would be.

    Anyhow, just some food for thought. Keep up the good work!


  3. Kevin and Brock,

    Thanks for the comments. A lot of people have heard of open source software nowadays, but it is still a new concept to many. Because of that there are misconceptions out there, and we’re still on the front end of the curve in terms of penetration into the clinical space.

    It’s very important for us to get people to realize that open source is as secure or more secure that proprietary software (how do you really know if there’s a back door in your database if you can’t review the source code?), and does not come with strings attached to your data. In fact, open source is the epitome of a model that allows complete data ownership. You have the ultimate control and knowledge, from the data itself through to the programs and platforms needed to perform operations on the data. While I do partially agree with the notion that open source is ‘not really free’, that is only in the context of needing to account for the time and expertise necessary to support and operate a system. It still offers tremendous cost advantages over proprietary alternatives.

    Brock, check out my follow-up post on validation. We continue to learn from the sponsor and CRO community. I think now we are able to offer a good combination of free, open source technology with paid-for services and carefully controlled quality and compliance-related artifacts. If you have additional thoughts I’d be interested in hearing them.


Leave a Reply