Regional cooperation key to containment and rebound

From : Communities>>Regulatory Open Forum
Hi everyone, As currently drafted,  the 2020 Chinese Pharmacopeia, the benchmark publication on the safety and efficacy of pharmaceuticals legally available in China, includes 319 new entries. The publication includes more than 5,500 traditional Chinese and Western medicines. The official compendium of the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug legally marketed in China is published by the Chinese Pharmacopoeia Commission. It is designed [More]

Q: If Notes to File can be regulatory red flags, should we quit using them?
A: No, and here's why...

Regulatory inspections are often conducted long after the conclusion of the study. When an FDA investigator asks you a question about an anomaly five years after it’s happened, will anyone recall the circumstances well enough to satisfy the regulator’s concerns? You’ll be doing yourself a huge favor if you write NTFs that answer the questions regulators might one day be asking you.



NTFs can be used to effectively explain an irregularity, locate a document, or note a change in procedures. While there are no regulations or guidances that govern NTFs per se, ICH E6(R2) 2.10 states “All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.” A well-written NTF will not only describe an event, but will document who made the notation and when, why the problem occurred, what was done to fix it, and what changes were made to keep it from happening in the future. That’s a lot, so it’s a good idea to develop an NTF template to remind authors to include these elements.

Example of a poorly written NTF:
Informed Consent for study BH-90210 was revised by the IRB 01/7/2017. Subject 867-5309 was not re-consented at her next study visit, as per IRB instructions.

This NTF does nothing more than document the deficiency.

Improved NTF:
Informed Consent for study BH-90210 was revised by the IRB 01/07/2017 to include lab procedures on Visit 5. IRB instructions required a re-consent for all enrolled subjects at next study visit. Subject 867-5309 was not re-consented at her next (2nd) study visit, but was re-consented at her 3rd visit.

This version of the NTF gives us a little more context and lets us know that the subject was re-consented before the new lab procedures were performed. The oversight was corrected in time to preserve Jenny’s* rights, but we still don’t know why it happened; there’s not enough information to satisfy a regulator that failure to re-consent was not a pervasive problem. What were the site’s re-consenting procedures at the time of this study? Were they being followed? Who do we ask?


Complete NTF Using Template



Since the subject was consented before the additional lab procedures were performed, there was no violation of informed consent regulations. This was an oversight with no ill-effects, not a significant break with procedures. Discussing it at the departmental meeting is an appropriate, proportional response. (Note that if the subject had not been re-consented before the new lab procedures were performed, the site would have been in violation of consent regulations and an NTF would not have been sufficient. Both the IRB and the sponsor would have needed to be informed of the failure to consent.)

A poorly written NTF – one that doesn’t provide enough information, one that identifies a problem but no solution, one that is inadequately standing in for proper record keeping – won’t satisfy a regulator’s concerns. These are the sorts of NTFs that can actually do more harm than good. A well-written NTF, on the other hand, is something your future self will thank you for.

In case you missed it, our last post was about how GMP activities affect GCP study procedures.
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* If you know why Subject 867-5309 goes by “Jenny," one of your friends wore a pink tux with shoulder pads to prom.

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

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UPDATE: The guidance mentioned below was released. Here's the link.

The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:

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Community pharmacies need millions of pounds extra “to keep their heads above water” during the COVID-19 pandemic, pharmacy bodies have warned.

To read the whole article click on the headline

All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.

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I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

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करेंट अफेयर्स एक पंक्ति को नए रूप में प्रस्तुत किया जा रहा है, इसमें विश्व रंगमंच दिवस और G-20 वर्चुअल सम्मलेन आदि को सम्मलित किया गया है.

टॉप हिन्दी करेंट अफ़ेयर्स, 27 मार्च 2020 के अंतर्गत आज के शीर्ष करेंट अफ़ेयर्स को शामिल किया गया है जिसमें मुख्य रूप से-विश्व रंगमंच दिवस और वित्त मंत्री सीतारमण आदि शामिल हैं.

प्रतिदिन के करेंट अफेयर्स से सम्बंधित जानकारी को संक्षिप्त रूप में प्रस्तुत किया गया है. इसमें आज कोरोना वायरस और मूडीज इन्वेस्टर्स सर्विस से संबंधित जानकारी संक्षिप्त रूप में प्रस्तुत किया गया है.

जागरण जोश प्रतियोगी परीक्षाओं की तैयारी कर रहे छात्रों एवं पाठकों के लिए डेली करेंट अफेयर्स क्विज प्रस्तुत कर रहा है.

जागरणजोश.कॉम पाठकों की सुविधा हेतु साप्ताहिक करेंट अफेयर्स से सम्बंधित जानकारी को संक्षिप्त रूप में करेंट अफेयर्स सारांश शीर्षक से नए रूप में प्रस्तुत कर रहा है. इसमें दी गयी जानकारी आईएएस, पीसीएस, एसएससी, बैंक, एमबीए और अन्य प्रतियोगी परीक्षाओं में सफलता के लिए अत्यंत महत्वपूर्ण है.

2012 XA133 or city killer as it is being called is the third asteroid heading towards the Earth.