Silence Is Golden
Polaris Compliance Consultants

We have some fun news to share. Last month, our parody “The Sound of Compliance” hit a milestone, surpassing 150,000 views on YouTube. 150,000 is hardly "Baby Shark Dance" territory, but it puts us handily ahead of the Consumer Reports megahit "How to Properly Load a Dishwasher." Surprisingly, only a quarter of "The Sound of Compliance" views originated in the U.S.; colleagues from 60 countries around the world account for the rest. Though over four years old now, the video continues to grab more than 2000 views per month. That means you’re still viewing it, you're still enjoying it, and you're still sharing it. And that's just great. Thanks to you all, from the bottom of our snarky little hearts.

Like Quincy, But for Data

An audit trail is a bit like forensic medicine for data. That a corpse is dead is obvious, but it takes an autopsy to figure out how it got that way. In an SBIA workshop, MHRA’s Stephen Vinter presented “Design and Effective Use of Audit Trails.” (It's towards the bottom of the page.) In it, he provides examples of the ways in which regulatory inspectors use audit trails to uncover compliance and data integrity issues. Companies that have procedures in place to regularly review their systems' audit trails will be able to identify and rectify those issues before the regulators find them.

You Have the Right to Remain Silent

Just because an FDA field investigator asks to see certain documents, doesn’t necessarily mean clinical sites have to comply. There are some records that FDA is not legally entitled to see, but that doesn’t mean they won’t ask. This article describes policies to put in place to ensure your site staff doesn’t share something that could be used against you while under no obligation to do so. (Because FDA field inspectors will not “mirandize” you – if you share it, it’s fair game.)

FitBit Tidbit

Canadian researchers conducted a study to evaluate the use of FitBit trackers for use in health research and for use in informing health care decisions. Their conclusion? “Other than for measures of steps in adults with no limitations in mobility, discretion should be used when considering the use of Fitbit devices as an outcome measurement tool in research or to inform health care decisions, as there are seemingly a limited number of situations where the device is likely to provide accurate measurement.”

They Don't Bite

Even when FDA inspections result in “No Action Indicated” (NAI) or “Voluntary Action Indicated” (VAI), it’s not always the end of the story. The Clinical Inspection Summary that follows is actually what determines whether the agency will take action on data integrity issues. Actions could include a repeat inspection, an inspection of other trial sites, or a third-party audit. Studies could also be forced to exclude questionable data sets.

To avoid such actions, this article recommends informing the FDA as soon as an issue is discovered, and asking the agency for help in resolving it. FDA actively encourages early engagement when an organization has a data integrity issue that arises during a trial.

Polaris QA experts know this is the FDA’s stance, and believe many organizations know it as well. Yet rarely do we see companies take it to heart.

Retroactive Compliance for Legacy Devices
It’s possible that a legacy medical device will be expected to conform to the GMP guidances that went into effect *after* the device was approved. This is an element of “continual improvement” that ICH Q10 emphasizes. Other potential GMP challenges can arise from changes over the years in CPGMs, quality agreements, a focus on data integrity, process validation, ICH guidance u[dates, and new expectations resulting from FDA inspection models.

Regulation Compilation Declaration! (Exclamation)
The 2020 edition of the International Compilation of Human Research Standards has been released and is now available online. The Compilation is a listing of over 1000 laws, regulations, and guidelines on human subject protections in 133 countries and from many international organizations. Sounds like a great beach read. #winkwink

Polaris Compliance Consultants Corner

Polaris is sponsoring Note in the Pocket’s Socks and Undie 5K Rundie fundraiser on April 25th. This is their biggest annual event to raise money for the more than 50,000 school children living in poverty in Wake County, NC. Note in the Pocket provides these children with well-fitting, school-and-weather-appropriate clothing.

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Older Posts

Clinical Trial Tips: Practical and Actionable

Getting the Most From Your GMP Supplier Audit

When Sites, eSystems, and Inspections Meet

FDA Puts Santa on the Naughty List

The One-Hour Study Site Audit

What Surprises GCP Auditors?

Hackin' the GDPR

eSource Terminology Untangled

Delegation of Authority Logs: Tips for Monitors

Study Sites: Show 'Em Your QC

Love at First Site: Early Signs of Strong PI Oversight

Anticipating Tensions Between Clinical Care and Study Protocol

Coping with Scoping your CSV/Part 11 Audit

Notes 2 Fix Your Notes 2 File

When GCP and GMP Meet

Site Selection: Don't Forget About the Study Drug

When is a Customer NOT a Customer?

Avoiding Protocol Deviations

Outsourcing Options for Small Sponsors

FDA Site Inspections: 5 Tips for Success

A Musical Parody: She's More Than a Warehouse to Me

Movie Quotes for QA Professionals

SOP Revision, SWAT Style

Study Sites: Too Many Vendors, Too Little Time

A Musical Parody: the Sound of Compliance

Q&A SOPs for Research Sites

Big Changes for ICH GCP and EU Regs

The CAPA Detective

A Musical Parody: the Modern Risk-based Monitor

Remote SDV/SDR: Alternatives to Redact/Fax

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

Regulatory Tools Go UFO: Useful, Free & Online

What Does Risk-based Monitoring Mean for QA Auditing?

Anatomy of a GMP Vendor Qualification Program

Is the SDV in RBM Misunderstood?

Results of First Ever REMOTE Clinical Trial

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

On the Quality of Vendor/Supplier Audit Responses

The Plain Writing Act of 2010: Lessons for Industry


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