GCP Video Series: Risk Assessment Monitoring

ClinOps Toolkit interview with Penelope Manasco Mana Consulting RBM
[box style=”0″]

Please subscribe to the Good Clinical Professionals series on our YouTube channel (link).  Daron Scott, Senior Contributor at ClinOps Toolkit will bring you new videos every month.  He is asking hard-hitting questions to find out what it takes to be an extraordinarily effective Good Clinical Pro!  Connect with Daron on Twitter @Scott_Daron

In our second interview, Dr. Penelope Manasco of Mana Consulting explains the new monitor skill-set as a shift from source data verification (SDV) to source data review and risk assessment.


Risk Assessment Monitoring Assures Quality Clinical Trial Outcomes

When monitoring clinical trials with a risk-based monitoring (RBM) approach, how do you determine Key Performance Indicators (KPIs)? How do you identify where the high-risk areas are? How can you assess them? How can you learn how to evaluate and interpret data? What kinds of things you need to know about technology? For each of those competencies, Dr. Penelope Manasco of Mana consulting is offering training.

Please enjoy excerpts from this Spring 2015 interview Daron Scott, Senior Contributor at ClinOps Toolkit conducted as part of our GCP (Good Clinical Professionals!) series. Dr. Manasco provides a great overview of why we should all be performing risk assessment monitoring.  Please watch the video here and read excerpts from the transcript edits presented to you below.


Penelope Manasco is a good clinical professional who knows about risk-based monitoring!

Penelope: I am Penny Manasco. I am the CEO of Mana Consulting and I have been in the pharmaceutical industry for more than 25 years.

  • I am unusual in that I’m a physician that went to medical school specifically to do clinical research.
  • I was a dietitian before I went to medical school and taught college
  • I was a Principal Investigator at the NIH.
  • I worked at GlaxoSmithKline in a number of different roles.
  • I’ve been an entrepreneur in the technology space
  • My whole passion has been clinical research.

Then, about two and a half years ago I started Mana Consulting to help the pharmaceutical industry better understand how to conduct clinical trials more efficiently.


Risk Assessment Monitoring

Why should the industry move to a Risk Assessment Monitoring method for Clinical Trials?

PM: The current approach that we in the pharmaceutical industry use for oversight of clinical trials is not adequate. I think it’s an unintended consequence that started with the expansion of EDC.

People felt that the important thing was to make sure that the data from the site, which is usually collected on source worksheets, is the same as what is in the clinical trial database.

What the FDA and EMEA say is that it’s gotta be part of an entire Quality by Design approach and that you really need to step back and look at the high-risk areas, the areas of patient safety, the areas the Good Clinical Practice, and of trial conduct.

Those are the areas where we need to spend our time.

SDV quote


The guidance for Risk-Based Monitoring (RBM), is this really a new method of monitoring?

PM: This is a continuation of a process that’s been going on in the device area and manufacturing for a long time.

We’re just finally catching up.

do work better quote


With traditional Source Data Verification (SDV) the monitor spends pretty much all their time going back-and-forth on transcription errors, do you agree?

PM: I think many times (I can’t tell you how many times!), I’ve had monitors come back and say, “All I had time to do…I didn’t get to look at informed consent…I didn’t get to do anything… I didn’t get to look at the investigational product, because all I was doing was SDV.”

SDV: your job was to compare size and color between two images instead of words.

SDV: your job was to compare size and color between two images instead of words.

If all you’re doing is point to point checking and you don’t step back and think about, “What am I looking at?”, then you miss the really important things.

Think about what’s important. What’s going to affect safety? If you only have limited time, spend it on that and don’t necessarily spend it on SDV because you’re not getting your quality that way.


How do I put together a quality Risk Assessment Monitoring plan?

PM: Up front, when you’re doing your monitoring plan, when you’re thinking about it. Whether you do the fancy risk assessment tool or you just say, “I’m an experienced monitor, where are my problems going to be?”.

Make sure that you look at that right away. Make sure that you’re thinking about:

  • “Okay, why did that mistake happen?”
  • “Is it happening at just my one site?”
  • “Is it happening at all my sites?”


You won’t catch some mistakes unless you look overall. Is it a trend, yes?

PM: One of the things I had a sponsor once say is, “We can’t let perfect be the enemy of good.”

If we could make improvements in the way we think about it, everybody wins.

Risk- based monitoring strategy evaluates key performance indicators across sites and subjects

Risk- based monitoring strategy evaluates key performance indicators across sites and subjects


Are clinical trial sites embracing Risk Assessment Monitoring?

PM: The site’s do worry, “How are you going to look at how I’m doing if you’re not here every four to six weeks? If you’re not doing this SDV?”.

airplane quote
What we have to teach them, and what we have to teach in the industry is to explain to them, “This is what I’m gonna look at. This is what I’m doing.

I’m still gonna talk to you every week and I’m going to expect that that data gets entered in EDC because I’m looking at it.” Instead of looking at it only every six weeks, I’m looking at it every day/week.

  • I’m checking behind you.
  • I’m not just checking on SDV.
  • I’m checking your informed consents.
  • I’m checking your rate of premature discontinuation.
  • I’m checking your rate of deviations.

All of these things. And together, they’re telling me how well you’re doing.”


Are CRAs excited about a move to Risk Assessment Monitoring?

PM: Why I’m really excited about this is, it’s a way of thinking.

So, regardless of whether they say your job as a monitor is to oversee the the quality of the sites that you’re responsible for, right?

What we’ve been doing as an industry is saying, “Oh, if I look at the SDV and I review a certain percentage of informed consents and I make sure all the the sites regulatory documents get sent in for the eTMF, I’ve done what I need to do.”

or “That’s all I have time to do.”

Instead, if what you say is, “I realize I need to look at these other kinds of markers of site performance and understand that those are telling me different things.


What skills are required for monitors transitioning from 100% SDV to Risk Assessment Monitoring?

PM: Everybody is struggling to with how to do this because the training that you need to do this centralized review is very difficult and it’s daunting.  You have to be able to determine and understand key risk indicators:

Evaluate error rate on key clinical data.

Evaluate error rate on key clinical data

One of the biggest benefits of this whole area of risk-based monitoring is to remember it doesn’t all have to be done by the monitor. The team approach in understanding what the data managers do and understanding how the medical monitors are looking at the data can really improve the whole process.
implementation quote
We led an international team of clinical folks that were from CRO’s, from sponsor companies, from device area,
from drugs, from academia, across Asia, Europe, and the US.

We worked to develop a set of competencies and ee have a total set. There are four competencies that we felt were very different for monitors compared to what their traditional role was.

  • One of those was to be able to look at all of the data for a patient and be able to do what we call, “source data review” as opposed to source data verification.
  • That is to look at all the pieces of information that you have and see if they make sense and if they align with the protocol and if you’re seeing safety issues, etc. That’s one of the things that we train monitors to do.
  • The second is to be able to do a centralized review which the FDA talks about.
  • How can you look at site performance across each individual subject, across a subject in the site,and then across the sites. There it’s easier to see the outliers.
  • How do you do that kind of evaluation? Being able to understand graphs, being able to interpret the data that you have, and then being able to translate that data into what we talked about earlier.
  • How do you do a root cause analysis? How do you figure out what the problems are for each site?
  • how do you implement remediation and most importantly, how do you identify whether it fixed the problem?
  • We can’t lose sight of the importance of interpersonal skills.

The full competencies were published in Applied Clinical Trials online in April 2014 and just republished
in their risk-based monitoring ebook that came out in December. Here is a link.

I think we can train people to do those things. The job in many ways is much much more rewarding.


What is the most important thing happening in our industry right now?

exciting stuff quote

PM: I love to talk about this!

We can tell!


Risk Assessment Monitoring Survey and Training

To assess your understanding of the new competencies, please take the survey (link):

Tell Mana Consulting what you want and need in your training.  If you are interested in Risk-Based Monitor training, take this survey:


Let’s Connect!

Daron Scott, Senior Contributor - ClinOps Toolkit

Daron Scott, Senior Contributor ClinOps Toolkit

Subscribe at YouTube and you’ll be informed first about our next GCP Video for ClinOps Toolkit (link).

Would you like to be showcased in our next video? Do you want to tip us off to more Great Clinical Pros that we can interview at the Toolkit?

You can connect with our Senior Contributor, Daron Scott anytime on twitter @Scott_Daron.  

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.

Leave A Response