Category: Uncategorized
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File Naming Conventions Matter
Written by Nicole M. Palmer and John R. Nocero Before you get started, it’s important to establish how you are going to name your files. This will ensure that your file names will remain consistent and that everyone will know what the process will look like and how it will work. Whether your TMF is…
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Follow These 3 TMF Tips for Career Progression
Written by Nicole M. Palmer It’s that time of year when you start thinking about the New Year and New Goals! You are tired of staying stagnant. We are creatures by habit to stay in motion. We are meant to move. We can only stay in one spot for so long until we get restless.…
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Trick or Treat Trial Master File
Trick or Treat TMF Written by Nicole M. Palmer and John R. Nocero Trick or Treat? What are you going to be for Halloween? Today my team and I dressed as the Backstreet Boys as we presented a collaborative approach to compliance. It was something that we decided as a group to do – all…
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TMF Gold
Written by Nicole M. Palmer and John R. Nocero If you’ve been keeping up with the weather in Florida, hurricane Ian was a category 5, which brought high winds and heavy rainfall that resulted in flooding and power outages. Several homes and businesses have been destroyed. When it comes to hurricanes, there’s a lot of…
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Burnout in Clinical Research Is Real
Written by Nicole M. Palmer and John R. Nocero Working in clinical research you can get burnout fast if you don’t set healthy boundaries. There are tight timelines and pressure from upward management to meet trial requirements. There’s always a sense of urgency. It’s important to set boundaries very early on. Set expectations and stick…
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Staying Audit Ready means BEING PREPARED
Written by Nicole M. Palmer and John R. Nocero Inspections are the apex of the clinical trial. It is something that study teams prepare for, plan for and ultimately get nervous about when they are going on. If you haven’t ever been through an inspection before, here’s what you should expect, according to the FDA. Usually, the…
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Peace, Love & Site Signature Sheet
Written by Nicole M. Pamer & John R. Nocero Last week, Nikki and I talked about Peace and what that brings to our lives. This week, we look at defining how to obtain a peaceful and up-to-date site signature sheet. It is easy to get into a war with the site signature sheet…rather, the people…
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TMF Inspection Readiness: There are no Shortcuts
Written by Nicole M. Palmer and John R. Nocero Some people love making a meal in the crockpot because when you cook low and slow the result is worth the wait. Then some people like to zap something quick in the microwave and have instant results. However, the results between the two do not taste…
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You Paid Them How Much?
Written by Nicole M. Palmer, Edye T. Edens and John R. Nocero You just received a vendor invoice and were asked by upper ward management to file it in the Trial Master File. The study is still new, and a Trial Master File plan has not been created. The sponsor has requested that you use…
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Sites Up and Running Lightning Speed
Written by Nicole M. Palmer and John R. Nocero “Lightning is a discharge of static electricity that has accumulated as a result of collisions between ice particles in storm clouds. The return stroke of a lightning bolt travels at approximately 100,000 kilometers per second, which is one-third the speed of light.” The pharmaceutical industry is booming!…
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10 Ways to Break into The Trial Master File Industry with No Experience
Written by Nicole M. Palmer and Dante Alducin 6 months ago, I did a poll on LinkedIn, and I asked, “How did you break into the TMF industry.” Do you know that more than half responded with NO EXPERIENCE! I am living proof that if I can do it so can you. I will always advocate…
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Get Your TMF Data Back in Shape with Integrity
Written by Nicole M. Palmer and John R. Nocero Have you ever looked at dirty Trial Master File (TMF) data? I would be lying if I said, ‘No.’ That’s because I am a person with integrity. I like to follow the rules and your TMF should too. Let’s look at ICH GCP E6 R2 and…
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TMF Secrets to Pass an Audit
Written by Nicole M. Palmer and John R. Nocero You just received written notice that the Trial Master File (TMF) that you are assigned is being audited by your internal QA department. Now what? Are you cool as a cucumber or sweating like you just ran a marathon? Being inspection ready is a lot like…
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If it’s FREE it’s for Me
Everybody loves free stuff. I know I do. Today I am sharing with you all of my FREE favorite things when it comes to looking for a job in the Trial Master File (TMF), FREE Good Clinical Practice Courses, and free TMF tips! My top 5 favorite ways to find that perfect TMF job! 1. https://www.linkedin.com/jobs/ 2. https://www.indeed.com/ 3. https://www.simplyhired.com/ 4. https://www.ziprecruiter.com/…
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Reduce Note to Files with Root Cause Analysis
Written by Nicole M. Palmer Do you cringe when you hear someone say, “Oh we can just write a Note to File?” Those exact words are like nails on a chalkboard. Often note to files are red flags for inspectors or auditors, leading them to investigate and ask more questions. In clinical research, an effective…