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Polaris Compliance Consultants
Santa Claus Gets a Warning Letter
Polaris Compliance Consultants

Oh no!  FDA found egregious CGMP violations when it inspected *Santa’s Workshop LLC* earlier this year, citing training deficiencies for its Enterprise Labor Force (ELF) team, as well as violations in its warehousing, distribution, and quality control operations. Read the Warning Letter here.

(Happy Holidays, everyone.)

1400 People Can't be Wrong
Polaris Compliance Consultants, Complion

Polaris Compliance Consultants was delighted to present Complion’s October webinar, “What ICH E6(R2) Really Means for Research Sites!”  1400 people registered for the live event, which speaks to the interest in the topic. If you missed the live presentation, you can still watch the recorded version that Complion made available to the public, free of charge. Far more questions were submitted during the webinar than we could address during the Q&A period, so we've answered them for you in this post. It was interesting to see that many of the questions related to documentation and document retention. These issues can be confusing for study sites, so we hope you find our responses helpful.

US Clinical Trial Snapshot
Igor Stefanov

Question: What percent of studies in the US are run by the 10 biggest sponsors?

Answer: 7% 

Is that what you'd expect? Do any of the other 3Q2018 clinical trial statistics in this article surprise you?

Accreditation and Competency Standards
ACRP, ACRES

The past year has seen some significant progress in developing objective standards for clinical research Investigators, staff, and sites. In October, ACRP announced an initiative to develop competency standards for Principal Investigators. This follows the January release of its Core Competency Guidelines for Clinical Research Coordinators. ACRP hopes that these two guidances will, among other things, help address the “one and done” phenomenon by giving prospective PIs a clear understanding of what running a study will require of both themselves and their most critical staff members.

Lastly, ACRES has started testing its Site Accreditation process, and is on target to begin accrediting study site early next year.

When Researchers Must Call Their Shots
CoyoteBlog
 
In 2000, regulations went into effect that required researchers to specify their primary outcomes in ClinicalTrials.gov. How have research results changed since researchers had to identify what they were looking for before the start of the study? You can read about the methodology behind the chart here.

Patients, Protocols, and Platforms
Nature

There have been a lot of articles about both the impact of social media on clinical research and the importance of listening to the patient perspective for study design, but few with as much heart as this.

Recommendations for Remote Trials
Clinical Trial Transformation Initiative (CTTI)

Whether you call them remote trials, virtual trials, siteless trials, direct-to-patient trials, or decentralized clinical trials (DCTs), research models that differ from the traditional site-oriented model impose common challenges. CTTI has developed a detailed set of recommendations to assist DCT researchers overcome those challenges. CTTI offers recommendations for protocol design, telemedicine licensing, supply chain management, delegation, oversight, and safety monitoring.

Polaris Compliance Consultants Corner

To all our readers, clients, and colleagues, we at Polaris extend our sincere wishes for a happy, healthy holiday season and a hopeful start to the new year.
 


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Older Posts

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

Risk-based Monitoring vs. Traditional Monitoring: the ADAMON Project

What if you Needed SOPs to Run your Household?

Key Points of FDA's Draft Guidance on Quality Agreements for Contract Manufacturers

Ignorance Isn't the Problem; Preconception Is

Who's Looking Out for the Investigator

What SOPs Do I Need As A Dietary Supplement Distributor?

Yes, SOPs are Hard to Write...It's Not Just You

Turning GMPs Into Marketing Advantage

 


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