ClinEssentials

TRUE or FALSE? A Trial Master File (TMF) or Electronic Trial Master File (eTMF) should be inspection-ready at all times. Comment with your response. Bonus point for sharing a tip for how you do this. Another bonus point for sharing a mistake you made - and what you do now to ensure you don’t make the mistake again.

Maintaining the Trial Master File (TMF) is a team effort. Each individual plays an important role in ensuring the TMF is accurate and inspection-ready at all times. What is a CTM’s role with the TMF? The CTM is responsible for the overall management and completeness of the Trial Master File. The CTM needs to be available in the event of a TMF audit or inspection. In addition, the CTM updates study documents that relate to the TMF throughout the trial - and makes certain the study remains in compliance. Read more about the role other members of a research team play with the Trial Master File here: https://lnkd.in/eH3EuW-E

CTAs: This Poll is for you! How often should you review the TMF for your study? A - Monthly B - Weekly C - Daily D - When the CTM asks E - When there is an issue F - Quarterly G - Annually H - Other (please share) Please comment with your answer below. Thank you for helping us learn from one another!

Let’s take a Poll! How often do you file emails to the eTMF? A - Once a month B - Once a week C - Immediately D - Per the company SOP E - Other Read more about the TMF here → https://lnkd.in/eH3EuW-E

Do you see clinical trial management as a future career? Did you know there are 4 roles in Clinical Research that transition to Clinical Trial Managers most often? These 4 roles provide the most seamless transition to the CTM role. By planning your career journey to include one of these roles, you can fast-track your path to CTM! Check out our FREE guide, How to Transition to a Clinical Trial Manager, to assist in planning your career path and goals. Click here for the FREE download: https://lnkd.in/ghZeaDB5

Trial Master File (TMF) and Investigator Site File (ISF) are often confused for one another - or are used interchangeably - but they are not the same. Every study has a TMF, which is a compilation of essential documents that together tell the whole story of the clinical trial. The TMF, which should be inspection-ready at all times, is important because it shows compliance, demonstrates successful study management, and showcases quality, uncompromised data. Reconciliation of the TMF is the responsibility of the Sponsor and CRO. Every participating research site also receives an Investigator Site File (ISF), which is also called the Regulatory Binder and is the responsibility of the site to maintain. The ISF contains essential documents such as the protocol, Investigator Brochure, protocol signature page, CVs of team members, IRB approval letter and patient consent forms, delegation of authority log, training logs and more. You can read more about the TMF and the ISF in this blog post: https://lnkd.in/eH3EuW-E

Here’s a hint that many aspiring research professionals don’t know - and it often costs them a lot of time spent on a job search. When you are looking for a job in Clinical Research, applying is not the first thing you should do. In fact, there are six steps you should take before you apply for jobs. We give you these six steps - and many more tips, facts, and resources - in the Introduction to Clinical Research Guidebook. You can buy it here: https://lnkd.in/eEsUZfc6 The information in this Guidebook will kick-start your Clinical Research career journey. You’ll be equipped with the must-know info about the industry, and the best, trusted websites and resources to use throughout your career. Here’s another hint: this Guidebook will get you started on a long, meaningful, successful career in Clinical Research. Buy the Guidebook now! https://lnkd.in/eEsUZfc6

Tiffany Ashton, MAS, CCRA, Director of Operations for ClinEssentials, sat down with Nicole M. Palmer, MS for her TMF Daily podcast. During the episode, called Trial Master File Career Paths, Tiffany and Nicole discuss many Clinical Research roles, including CRC, CTA, CRA, CTM and PM. Watch it here: https://lnkd.in/e4pTfCFX You’ll hear about these topics and much more: - How to learn the Investigator Site File as a CRC - The value of the CTA role - Importance of collaboration for the CRA and study team - The CTM role: helpful soft skills, advice for people who want to become CTMs, and more - Difference between a CTM and a PM This is a beneficial listen for research professionals at any stage in your career. https://lnkd.in/e4pTfCFX

Summer fun has begun! But not if you’re overloaded with work… Boost your efficiency with time-saving tools from ClinEssentials - and spend less time working and more time “summering!” CRA Audit Notes are proven to increase efficiency when monitoring by up to 30%! Think of all the extra time you’ll have for walks, the pool, gardening, BBQs, etc. CRA Audit Notes (and [almost] ALL of the items in the ClinEssentials Shop) are 50% OFF - but the sale ends tomorrow (June 2, 2024 at 11:59 pm PST).* Shop Now: https://lnkd.in/diw8qZ6Z Limited quantities are still available! *The CTM Training Course is not included in this sale.

The road map for Clinical Research jobs is not always clear. Many aspiring research professionals find themselves driving in circles, and getting nowhere fast. To help you get off the slow and windy road and veer on a fast and straight path, ClinEssentials created the Introduction to Clinical Research Guidebook. The Guidebook is your clear road map that will lead you to Clinical Research career success. Lift the fog and buy the Guidebook here: https://lnkd.in/eEsUZfc6 Aspiring Clinical Research Professional, Javier G., says: “The Introduction to Clinical Research Guidebook takes you by the hand and walks you through not only how to enter the clinical research industry but to progress towards senior roles. I feel more confident in how I need to approach my strategy in becoming a clinical research professional!” Your clear road map to Clinical Research is waiting! Buy it now: https://lnkd.in/eEsUZfc6