Back on my RBM Soapbox

Time for another installment of Nadia’s RBM Soapbox

More from Transcelerate this week on the Risk-Based Monitoring (RBM Methodology).  Check out the July update here.

As an industry, we absolutely need more conversations about quality, oversight, completeness, and appropriate monitor expectations.  So don’t get me wrong, I love dialogue on this and many other topics. Join the conversation in the comments, shoot me an email, or connect to our free and open discussion group ClinOps Toolkit at LinkedIn.

RBM Soapbox: Challenging the Value of SDV

Every time I read about their so-called “challenging the value of SDV” initiative I find it incomplete. I’ve heard nobody yet suggesting measuring the rates of data entry in the days leading up to monitoring visit, during those visits, and the days following. They keep focusing on query rates which are just one measure of data completeness and quality. I can open queries all day long that do nothing to improve quality. I think that having the monitor on-site is like a carrot-stick approach to get the study staff to actually put the data properly and in a timely fashion into EDC. Only then can we talk about centralized statistical monitoring and meaningful remote analysis. From their analysis, I see this review of data input cycle times as a glaring omission.

RBM Soapbox: Does source data verification (SDV) protect subject safety?

To the degree that unreported adverse outcomes and accurate/precise patient characteristics, responses, and measures are located in the source and then reconciled/added to the database when missing or incorrect, sure. SDV alone does not create quality, it is that gap review and asking questions about missingness and gaining clarifications (that get entered into safety reports and the database) that makes the monitor’s SDV process so valuable. We can’t remotely monitor data that simply hasn’t yet been entered.

I still maintain that the unique value monitors bring while on site is the cooperative auditing approach to monitoring: reviewing for negative trends, and assisting the site in avoiding important protocol deviations. The simple, “does this match that” exercise is really not what I am paying my monitors for, never was. The trending piece is becoming easier to do remotely, as is the reinforcement of protocol training. That auditing piece though, confirming appropriate investigator oversight, reviewing that authorities have been delegated appropriately and only to trained and qualified persons, checking that the records are complete, attributable, organized, etc. These items, are just easier now to do in-person.

Don’t get me wrong, I love remote monitoring

I support the increased vigilance and review of data both in aggregate blinded fashion and for individual patients. However, I still want my monitors on site within 2 weeks of the first subject enrollment, I still want phone calls to reinforce protocol training if certain thresholds of time have passed between screening/enrollment activity. I want the monitors there to review IP storage and record-keeping, check supply levels, cheerlead and encourage quality patient recruitment and reinforce the goals of the trial. I am counting on my trained monitors to perform eligibility and compliance checks to make sure that the enrolled subjects actually end up in the analysis set.

We can have RBM, Just Not in Lieu of Real Quality On-site Visits

OK, climbing down off of my RBM Soapbox now for closing thoughts.  in short, RBM metrics and “risk-indicators” should not be used to justify canceling monitoring visits or limiting this important oversight activity. Regular on-site monitoring visits according to plan remain imperative to confirm quality data and ensure subject safety.

Please join the conversation below in the comments, at one of San Francisco Bay Area ClinOps Toolkit Meetup events, or in the LinkedIn ClinOps Toolkit discussion group.  Are you an RBM fan or do you have your own right-sized RBM Soapbox?

Further reading at the ClinOps Toolkit blog:

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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.