Remote SDV/SDR: Alternatives to Redact/Fax

By Laurie Meehan

As part of their risk-based monitoring strategy, many sponsors and CROs are using remote techniques to conduct source data review and verification (SDR and SDV).  The best implementations out there actually streamline activities at both ends, both for sponsors/CROs and for study sites.  This happy outcome relies on the right combination of enabling technology, privacy/security policies, and source documentation procedures.  At its most elegant, monitors can coordinate with the sites to receive (i) remote, (ii) temporary, and (iii) restricted access to their EMRs.  All quality review of source documentation can be conducted off-site.  Questions and queries about the source data can be also resolved remotely, sometimes by phone and sometimes using online meeting software like WebEx.  With SDV/R complete, on-site monitors can focus on assessing other, more “presence-demanding” study elements, such as drug accountability and PI oversight.

How to Tip Off a GCP Auditor in 25 Words or Less

By Laurie Meehan

“What tipped you off?”  “How did you know to look there?”

When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees.  Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice.  And other times, not so much.

The Principal Investigator and Study Coordinator comments below are real; these are conversations our auditors had with site personnel.  Really.  No kidding.  Pinky swear.  The audit findings, not surprisingly, are real too.  I do confess to having taken some liberties with the Auditor Notes and Remediation Recommendations. 

Regulatory Tools Go UFO: Useful, Free & Online

By Laurie Meehan

Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations.  Indeed, that’s why many people stay away.  But if you can tolerate a little noise, I’ve found the fruitful far outweighs the fruitless.  Case in point:

LinkedIn Member 1: “This looks like a great resource. I just hope they are planning on adding more countries.”
[I bet you wanna know what he’s talking about. Stay tuned.]

LinkedIn Member 2: “Don't you find it encouraging there are more and more online tools available to us?”
[Who is this sickening optimist?]

LinkedIn Member 1: “I do find it encouraging. What's the best way to keep up with all these new tools? Is there a web site keeping track of them?”

Ok, I’m LinkedIn Member 2, and the short answer to the question about tracking is "no".  But I've been maintaining a laundry list of useful regulatory websites and online tools for myself, so thanks to this discussion, I scored my first blog topic for 2015.  In no particular order, here are some of the tools/sites on my list.  (The first in the list is the subject of the LinkedIn discussion above.)

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.