LMK Blog

Is Your TMF Ready For GDPR? Part Three: Know Your Responsibilities

April 17, 2018

Is your TMF ready for GDPR? This is the third and final post of a series examining how the new European Union General Data Protection Regulation could affect your trial master file. See part one and part two which examine the basic roles within GDPR and the foundational rights of data subjects. Serious Penalties and…

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Bridging The ISF-TMF Divide: What Roles Should Sponsors & Investigators Play?

April 10, 2018

Regulation, more than just stipulating what must be done, must also define whose job it is to complete the task. The assignment of responsibility within the regulatory framework surrounding the clinical trial is essential to protecting the well-being of subjects and the validity of the trial’s data. Clear demarcation of the primary roles of sponsor…

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Is Your TMF Ready For GDPR? Part Two: Know Your Rights

April 5, 2018

Is your TMF ready for GDPR? This post is the second article in a three-part series examining how the new European Union General Data Protection Regulation could affect your Trial Master File. In our last post on the European Union General Data Protection Regulation (GDPR) we examined the primary roles found within the regulatory framework…

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Is Your TMF Ready For GDPR? Part One: Know Your Roles

March 28, 2018

This post is the first in a two-part series outlining how the new European Union General Data Protection regulation could impact your Trial Master File. Since 1995, EU Directive 95/46/EC has provided the foundation for “the protection of individuals with regard to the processing of personal data and on the free movement of such data”.…

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The Silliest Thing We Can Imagine

March 6, 2018

Elon Musk decided to test his revolutionary Falcon Heavy rocket with the “silliest thing we can imagine”. Usually test payloads for new rockets are made of boring hunks of steel and concrete, but if Elon’s past actions are any indication –see his Boring Company branded flamethrower— normal just wouldn’t do. So Musk tweeted out this…

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Fear, Indecision, And The Memo To File

February 23, 2018

“Just write a memo to file.” How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself? A memo to file (MTF) is a document filed in the trial master file (TMF) that is intended to…

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The Spirit of the Olympics in your TMF

February 21, 2018

The PyeongChang Olympics have begun with a flurry of inspiring headlines: Shaun White takes the gold medal and regains his crown’ Russian athletes allowed to compete despite doping controversy’ Unified Korean women’s hockey team takes the ice under united one flag’ These headlines give us hope that the Olympic Games reflects the best of humanity.…

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Romance in the TMF

February 12, 2018

I bet you are familiar with those cliché candy hearts, but did know those little hearts share some history with the pharmaceutical industry? Conversation hearts were first invented in 1847, when Boston pharmacist Oliver Chase decided he wanted to make his fortune in the apothecary lozenge fad of the mid-1800s.  While Chase was working as…

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Embracing the Risk-Based TMF

February 8, 2018

Introduction The release of the 2017 ICH GCP E6(R2) guidelines marks a paradigm shift in clinical research. Risk is mentioned no fewer than 30 times in the guidance. ICH GCP E6(R2) section 5.1 requires that the sponsor of a trial, “implements and maintains systems for quality assurance and quality and control.” 1 The EMA recognizes, that although…

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