Risk-based Monitoring Fatigue

I had Risk-Based Monitoring Fatigure and I thought about starting a support group

If I hear “risk-based” one more time…

When it comes to monitoring clinical trials, I feel like “risk-based” is the buzz word for 2013. Every time I heard the phrase I was having an emotional response: a mix between anger, annoyance, and amusement. I had more or less refused to write about it as a topic on my CRA blog (thank goodness the nice folks at Medidata volunteered to write a post there, instead!). My co-workers would pop by my cube and say “risk-based” to me just to get a rise. I would promptly climb up on my soapbox and start exclaiming that “risk-based” monitoring is a fad, it can’t be implemented practically, we will never do that here!

I’m Starting a Support Group

And I kept hearing the phrase. Over and over. On every conference agenda, in every other webinar invitation, in all the CRO info sessions I attended, in job descriptions on the internet, in magazines, all over my email…enough was enough. I was experiencing “risk-based” fatigue.

And that’s a promise, not a threat

So I re-read the draft guidance, I took an objective look at all the CRO marketing materials, I read the position paper from Transcelerate a few weeks ago, I started attending the webinars with an open mind, and I began having real discussions about risk-assessment and central statistical monitoring with my colleagues. And guess what? I’m actually coming around as a proponent for “risk-based” monitoring.

Incidentally, it turns out that I have been unknowingly advocating for “risk-based” monitoring for the last several years of my career. I’m a huge fan of diverse monitoring methods (remote monitoring, communication/escalation plans, reviewing EDC metrics and formulating action plans, searching for and addressing trending patterns and anomalies, measuring cycle times, etc.) and I’ve been campaigning at The Lead CRA blog for more than 5 years that the modern Clinical Research Associate (CRA) must diversify their skillset and focus on building deep personal relationships with their sites in order to assist in the success of a clinical trial. I’m still working on getting comfortable with the idea of anything less than 100% Source Data Verification (SDV) but I’ll stop here because I have a LOT more to say about this topic and I will save it for another post(s).

Why was I So Frustrated Before?

At the core of it, I really think the thing that was making me so reactive when I heard the term “risk-based” was one part fear that we would be sacrificing the quality and integrity of our clinical data by insisting on less oversight and one part insult at the commoditization of CRAs; I perceive the role of on-site monitoring is becoming more obsolete.

Fortunately, after researching the topic further, I am more hopeful that the industry aims to increase the oversight of trials using “risk-based” monitoring, not sacrifice data quality (depending obviously on how “risk-based” monitoring is actually deployed). I’m also hopeful that CRAs can modernize their skillset and adapt to the evolving needs of the industry and I will do my part to help.

Let’s Have a Conversation about Data Quality

I have pages and pages of notes now on “risk-based” monitoring and my position is definitely changing on the topic. I’m looking forward to diving into those topics more in future posts to this blog. Thank you for following along and I hope that I will receive comments and emails from more of you.

If you are a CRA or employed in some other relevant role in clinical trials and I’ve said anything that struck a nerve then we absolutely need to network. Please send me an email so we can start the conversation. I definitely want the monitor’s perspective and I’d like to personally invite you to work with me to write a blog post for other CRAs at The Lead CRA.

Read on

Costs of Risk-Based Monitoring June 2013

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About The Author


Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

1 Comment

  • Karen

    August 6, 2013

    It’s good to hear that you have “come around” to a more positive attitude towards risk-based monitoring! I too was a bit skeptical at first but after reading and researching, decided this could be really good, not only for our industry, but for public health and the patients who will hopefully benefit from the products we develop. I look forward to more posts about the “RBM word.”

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