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How the EU Clinical Trials Regulation (EU CTR) Changed eTMF Site-Level Filing
The EU Clinical Trials Regulation (EU CTR) 536/2014 has brought significant changes to clinical trial management across Europe, including how Trial Master Files (TMFs)—especially electronic TMFs (eTMFs)—are maintained at the site level. Understanding these changes is crucial for site teams, sponsors, and CROs to ensure compliance and efficient document management. What is the EU CTR?…
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Rocky III and the eTMF Specialist: Finding and Keeping Your Eye of the Tiger
Written by Nicole M. Palmer & John R. Nocero There’s something incredibly alluring about underdog stories; they tug at our heartstrings and allow us to see parts of ourselves in the character’s triumphs and defeats. For many, the movie “Rocky” is not just a cinematic masterpiece but a reflection of the highs and lows of…
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25 Tips for Risk-Based Approaches to TMF Management
Written by Nicole M. Palmer In a time where new and amazing things are being invented every day, there’s an important change happening in the world of scientific experiments, a change that asks us to think differently about how we manage Trial Master Files (TMF). I see this as a chance to make the process much smoother…
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Redefining TMF Training
Written by Nicole M. Palmer & John R. Nocero How many times do we just do our homework quickly to get it done, without really learning and understanding it all the way? It’s kind of the same with training in the trial master file. Have you ever heard the phrase, “Where there is smoke, there is…
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5 Steps to GOAT Status as an eTMF Specialist
Written by Nicole M. Palmer and John R. Nocero A G.O.A.T, or “Greatest of All Time,” is someone who excels in their field. A paragon of excellence. Best of the Best. Exceptional individual. Unwavering professionalism and exceptional conduct are only four values that GOATS exhibit on a daily basis. Everything is done with unwavering conviction.…
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TMF Careers: Navigating the Illusion of Greener Grass and Finding Home
Written by Nicole M. Palmer & John R. Nocero Hey there! John and Nicole TMF vibes coming your way! Remember that catchy tune “Hook” by Blues Traveler? Well, it’s more than a melody—it’s a gateway to rethinking our take on the workplace boomerangs. Back in 2019, we started using the term “boomerang” to describe those…
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15 Empowering Tips to Overcome the Sting of a Trial Master File (TMF) Job Layoff
Written by Nicole M. Palmer & John R. Nocero Imagine you had a Trial Master File job that you absolutely LOVED. A job that you loved so much where you were a TMF superhero. But one day, something unexpected happened, and you had to say goodbye to that job. It might feel like you’ve lost…
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Are you a TMF Hero or a Villian?
You either become a TMF hero or stay employed long enough to see yourself become the villain of compliance. Let me share a cautionary tale about my journey with the Trial Master File. In 2020, I joined a clinical trial team and quickly became the go-to person for managing the Trial Master File. From the…
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Recruiting Trial Master File Professionals: Essential Qualities and How to Stand Out
Recruiting the right Trial Master File professional is crucial for ensuring the smooth management of clinical trials. These individuals play a vital role in maintaining organized and compliant trial documentation, safeguarding data integrity, and supporting efficient regulatory submissions. In this blog, we will explore what qualities recruiters and hiring managers look for when recruiting TMF…
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The Importance of Researching Specific Roles in the Trial Master File for Your Career
Written by Nicole M. Palmer and John R. Nocero When you are considering a career in the clinical research industry or looking to make a career shift it’s crucial to research and dive deep on the various roles available within the Trial Master File (TMF) to find your perfect fit. The TMF is an essential…
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Unleashing the Power of Decentralization in Trial Master File Talent Acquisition
Greetings, Forward-thinking TMF Professionals! Welcome to the latest edition of Granular Level, your trusted source for all things related to the world of Trial Master File (TMF). In this issue, we explore the correlation between decentralized clinical trials and how employers should embrace decentralization when hiring TMF candidates. The Rise of Decentralized Clinical Trials Decentralized…
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Why Internal TMF Mock Inspections are Essential for Clinical Trial Success
Today, I want to talk about something that’s crucial for anyone working in the clinical research industry – the importance of conducting internal Trial Master File (TMF) mock inspections. For those of you who may not be familiar with the term, the TMF is a collection of essential documents that provides a complete history of…
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Inside a TMF Mind
By Nicole M. Palmer and John R. Nocero Motivation and personal development help people achieve their goals and become successful. Learning how to cultivate a positive and organized mindset when it comes to maintaining a Trial Master File is essential to ensure you are giving your best. The TMF is a very valuable piece for…
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I Love the TMF: Your Guide to Staying Organized
Written by Nicole M. Palmer As a professional in the clinical research industry, you understand the importance of maintaining a well-organized TMF. It is the backbone of any clinical trial and contains all the documentation necessary to support the study’s conduct, from start to finish. But, with all the documents, processes, and stakeholders involved, staying…
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Are You a Laggard in Clinical Research?
Written by Nicole M. Palmer and Edye Edens In a world of innovative and life-saving therapies, where we constantly push scientific and biomedical boundaries, how is our industry still full of late adopters? As a research compliance expert, this is one of the most frustrating elements of the clinical trial industry. We surround ourselves in…
