What Does Risk-based Monitoring Mean for QA Auditing?

By now, we all know that risk-based monitoring isn’t just about changing the role of the CRA; it’s transforming the way clinical studies are managed.  So what does that mean for QA teams who audit these new processes?  Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

It’s a slippery subject.  Traditional monitoring relied on the gold standard of on-site visits every 4-8 weeks and 100% SDV.  RBM is not replacing this standard with another.  RBM is a framework for customizing a monitoring approach for each study, and guess what -- “custom” is a lot trickier to audit than “standard.”

Two New RBM Papers from TransCelerate

From One, Come Two
If you follow the TransCelerate RBM initiative closely, since its July update you’ve been eagerly anticipating the availability of the paper entitled “TransCelerate BioPharma: Central Monitoring Model and Technology Specification Proposals to Enable Risk-Based Monitoring Adoption.”  Now that the paper is publically available, your patience has been rewarded twice.  TransCelerate chose to divide the single document into two, one focusing on central monitoring, the other focusing on RBM-enabling technologies.  Publishing separate documents was a good decision.  As you’ll see, each topic is certainly rich enough to warrant individual treatment.

Anatomy of a Vendor Qualification Program

Pharmaceutical companies are only as compliant as their vendors.  In a contract manufacturing arrangement, the manufacturer is held responsible for any cGMP deficiencies; however, you, as the sponsor or CRO, would be held responsible for your lack of vendor oversight.  Moreover, if your manufacturer fails to meet regulatory standards, you could lose millions in profits and patent exclusivity, damage your company’s reputation, and even jeopardize your entire business.

And that’s why a vendor qualification program is so critical.

Is the SDV in Risk-based Monitoring Misunderstood?

What’s in a name?  Not much according to Shakespeare.  But the man who penned “A rose by any other name would smell as sweet” was a 16th century poet and playwright, not a 21st century clinical research professional.  For us, names matter.  Despite recent efforts to standardize the definition of Source Data Verification (SDV), the term still means different things to different people, and that needs to be navigated very carefully. 

Results of First Ever REMOTE Clinical Trial

In the clinical research industry, we’re always evaluating things.  We evaluate drugs and biologics.  We evaluate medical devices.  We also evaluate research techniques.  Yes, we try trials.  We study studies.  That’s what Pfizer was doing when it launched its REMOTE pilot trial in early 2011 – evaluating the effectiveness of a study in which patients participated remotely, without ever having to visit a study site.  How would the results of the REMOTE study compare with those of a similar, completed, conventional study?  Would this innovative research approach be validated?

A Curated Collection of Tweets from ACRP 2014

Some Polaris staff members attended ACRP last month in San Antonio. It was a great conference. See what we and other attendees had to say about a few key sessions here.

(This Twitter compilation was extremely easy to curate and annotate using a free service called Storify. You don’t even need to have a Twitter account to do it. In fact, you don’t even need a Twitter account to follow a conference hashtag. Feel free to contact us via our website if you’d like to learn how; we'd be glad to share!)

Questions All Auditors Should Ask: the Use and Misuse of Audit Checklists

There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: "Why?"  How can you develop the best checklists possible and avoid relying on them too heavily?

On the Quality of Vendor/Supplier Audit Responses

The Compliance Perspectives post this month was written by guest blogger, John Janeri, an independent contractor working with Polaris.

After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.  I’ve done many of these solo audits, and I’ll admit that I've often wondered who at the Sponsor* company would communicate the findings to the Auditee and review their responses.  But no matter, I've completed the contracted assignment and I'm now off doing something else, right?  Not so much anymore.

Summary of TransCelerate’s Update to its Risk-based Monitoring Position Paper

The 7-page document provides an update on TransCelerate’s Risk-based Monitoring (RBM) initiative.  It includes a list of lessons learned, shares FDA feedback on RBM pilot studies, and provides links to RBM training developed by TransCelerate (TCB) member companies.  It also outlines 2014 publishing plans.

The Plain Writing Act of 2010: Lessons for Industry

FDA and other federal agencies are bound by the Plain Writing Act of 2010 to use “clear government communication that the public can understand and use.”  It seems ridiculous that we’d need legislation for such a thing, since “understandable” and “useful” are such obvious and fundamental attributes of communication.  There’s even a companion document, the 118-page Federal Plain Language Guidelines (FPLG).

Be us not, in industry, too smug.