|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
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
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
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
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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