Informed Consent: The Story Your TMF Needs to Tell

October 5, 2017

Of all the documents making their way into your TMF, the informed consent form is the most important. Although you probably already knew this fact, do you know how it came to be this way? Why do auditors and inspectors review 100% of the informed consent documents, and typically do so before reviewing anything else?…

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When it comes to Inspection Readiness – Knowledge WINS.

October 5, 2017

Per GCP Directive 2005/38/EC: Chapter 4 Article 16, the Trial Master File (TMF) is THE basis for an inspection by the Regulatory Authority. The definition of TMF Inspection Readiness therefore includes being prepared for a regulatory inspector to reconstruct the clinical trial conduct, using all pertinent data and metadata in the TMF. Essentially, this means…

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Investigative Site Files and Trial Master Files Should Talk to Each Other

August 14, 2017

The major deliverable of a clinical study is an organized collection of documents called a Trial Master File (TMF). The FDA (or any regulatory authority) may review the TMF to determine whether the drug, device or diagnostic product is suitable for marketing. The ICH Guideline for Good Clinical Practices (E6 (R2)) Section 8 specifies the…

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eTMF Placeholder: The Mirage of the TMF

June 6, 2017

When I was first introduced to the concept of Placeholders (PHs) for eTMF over four years ago, I was SO excited! We were in the process of performing TMF reviews for hundreds (yes, hundreds) of studies. I thought, “YES, FINALLY, some intelligent engineer has figured out a way to determine TMF completeness automatically! We don’t…

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What the New England Patriots’ Super Bowl Win Can Teach Us About the TMF

February 9, 2017

On Sunday evening, millions tuned in to watch the team everyone loves to hate (the New England Patriots, of course) make their ninth Super Bowl appearance in a 1:1 match-up against the Atlanta Falcons. For the first three quarters, it seemed as if the Falcons had “risen” and were on their way to take home…

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To Migrate or Not to Migrate? That is the Question

September 22, 2016

You have a shiny new eTMF technology with all of the bells and whistles that you and your team thought would only be possible in your dreams!  Finally, TMF documents can be loaded without a second thought to inspection readiness because this new system provides instant access on your computer screen to what is present…

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Veeva 2016 Paperless TMF Survey

August 29, 2016

At the 2016 Drug Information Association (DIA) conference in Philadelphia a few weeks ago, Veeva released the third annual Veeva 2016 Paperless TMF Survey. The goal of this 13-question Survey (many of which included sub-questions with response matrices) was to further understand the impact of the electronic TMF (eTMF) adoption on clinical processes and the…

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TMF Quality Control or TMF Inventory: What’s the Difference?

May 20, 2016

Over the years, I have participated in and managed a number of TMF Quality Control (QC) projects, and it has become one of my favorite activities. It’s one of the reasons I am facilitating the Metrics Champion Consortium (MCC) initiative on the TMF and leading the quality work stream for the TMF Reference Model. One…

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Five Reasons Why TMF Training is Important

February 29, 2016

Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, US companies spent over $70 billion on corporate training in 2014, an increase of 15%…

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