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Polaris Compliance Consultants
eSource Terminology Untangled
Polaris Compliance Consultants

Can you pass this 2-question eSource True/False quiz?

Though FDA has formally defined the term “eSource” for clinical investigations, casual use often leads to conversational cross talk. In “eSource Terminology Untangled,” we offer a short, easy-to-follow description, provide multiple examples, and remedy some of the more common confusions we hear.

It's GDPR Time - Do You Know Where Your Data Are?
Journal of Best Clinical Research Practices

The EU’s General Data Protection Regulation (GDPR), which becomes effective this month, will have significant global impact on the collection and transmission of clinical trial data. Here, the HHS Secretary’s Advisory Committee weighs in on GDPR, reconsenting, and right to withdrawal.

“The application of GDPR requirements to human subjects research has alarmed many in our national research community, as the GDPR appears not to have taken into account  adequately the nature, process and demands of scientific and medical  research.”

There's Nothing Artificial About Improvements Like These
Outsourcing-Pharma

Artificial Intelligence is leading to significantly better clinical trial enrollment and significantly faster screening times. Using IBM’s Watson, Mayo Clinic has seen an 80% increase in clinical trial enrollment for oncology studies. Watson also helped Highlands Oncology Group and Novartis cut average screening time by 75%. These are huge numbers.

Move Over, Snapchat
FDA

You’ll be the life of the party with this on your phone. The Drugs@FDA Express app provides quick access to information about FDA-approved drugs and recent drug approvals. The app shows the last 7 days’ approvals, links to the full Drugs@FDA website, and supports searches by drug name, active ingredient, or application number. The app also has a product information and approval history tab which shows the three most recently approved labels.

You can download the app for Android devices via Google Play for free. It's currently fairly well-rated.

You can download the app for iOS devices via the App Store for free, though comments indicate it currently isn't working well.

Handy GMP Reference
Loganathan Kumarasamy
 
Complying with data integrity requirements from different regulatory agencies can be difficult; FDA, EMA, and MHRA each have their own focus. This article provides a helpful comparison of the nuanced approaches to data integrity that each agency takes.

The Barcode Challenge
ClinicalTrialsArena

Standardization is the key to barcoding. That’s what has made it useful across companies in supply chains and across trading partners since the 1970s. That same standardization is what makes barcoding difficult to apply to investigational product (IP) labeling, because clinical trial processes have complexities not seen in the commercial world. An IP may be intended for only a single patient, and, of course, the trial could be blinded. Other industry sectors don’t have to contend with these complications.

Regulatory News from the EU
Pharma GCP / MakroCare

The common submission portal, a precondition for implementation of the EU Clinical Trial Regulation (CTR 536/2014), is experiencing more delays. Release 0.7 should be available for audit early next year, after which regulators can better estimate an implementation timeline.

MakroCare provides a summary of the changes under the EU medical device regulation MDR 2017/745. All changes go into effect in 2020, which sounds really far away, but it’s only 19 months from now…which probably explains the sudden burst of MDR articles on social media.

Polaris Compliance Consultants News

Polaris President Celine Clive and Senior GCP Auditor Karen Sargent will be attending DIA 2018 in Boston at the end of June. If you plan to attend and would like to meet up, just let us know. Coffee and Compliance go well together!
 


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Older Posts

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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