TMF Daily

Investigator Site File: Site Owner Perspective

In this episode of the TMF Daily Podcast, we’re talking about the Trial Master File (TMF) at the site level, straight from a site owner's perspective.
Joining us today is LaToya Hinton-Howery, a powerhouse who began her clinical research journey as a Study Coordinator and climbed her way up to become a site owner with just $200.
TMF Elite, this episode is packed with insights as LaToya shares her experiences with the Investigator Site File (ISF), also known as the regulatory binder. From learning the ropes of the ISF as a newbie CRC to opening her own site, LaToya has seen it all. We’ll discuss her strategies for managing the ISF, coordinating with her team, dealing with budget challenges, and the crucial role of technology in maintaining compliance.
Plus, she’ll reveal her tips for handling audits remotely and why having a backup person is a non-negotiable in clinical research.
So, get ready to learn from a true ISF expert. 
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Enjoy the show! #clinicalresearch #site #trialmasterfile

How Clinical Research Can Transform Your Career

In this episode of the TMF Daily Podcast, we’re diving deep into how a clinical research career can transform your life. Our special guest, Elizabeth Weekes-Rowe, brings a wealth of knowledge and experience as a nurse turned Study Coordinator, now thriving as a CRA.
Elizabeth is not only an accomplished author but also a renowned public speaker in the clinical research community.
Today, she shares her unique journey from nursing to clinical research, offering invaluable insights for those looking to make a similar transition.
We discuss the importance of attending conferences, how to select the right ones, and Elizabeth’s tips for those aspiring to become confident speakers.
She also sheds light on the evolution of training and mentorship in the industry, providing a comparison of her experiences from when she started to the current landscape.
For our TMF enthusiasts, Elizabeth offers practical advice on why Clinical Trial Assistants should read monitoring visit reports, the importance of timely escalations, and examples of issues that should be escalated.
To wrap up, Elizabeth shares the best career advice she’s ever received and reveals her favorite TMF document.
Tune in for an inspiring and informative conversation with one of the leading voices in clinical research! Don’t forget to like, comment, and subscribe for more expert insights.

Top Trial Master File Best Practices for CRAs: Expert Insights and Tips

Hey TMF Daily enthusiasts! Welcome back to another power-packed episode. Today, we're diving deep into the pivotal role of the Clinical Research Associate (CRA) in the Trial Master File. Whether you're an eTMF Specialist or a Clinical Trial Assistant, this episode is a must-listen as we uncover the crucial responsibilities and interactions of CRAs.
Here's what we'll be breaking down:
*The essential documents you need at a Site Initiation Visit (SIV)
*The critical details CRAs look for in the Delegation of Authority (DOA) log
*Six essential steps that CRAs follow during a Monitoring Visit
Joining us is the incredible Maria Alexander Milas. Maria holds a Master’s Degree in Clinical Trial Monitoring, is a Certified Clinical Research Professional (CCRA), and has extensive experience in clinical operations spanning both CROs and sponsors.
So get ready for an episode packed with actionable tips and career-changing insights for all you CRAs and clinical research professionals out there.
Don’t forget to subscribe, share, and leave us a review. Until next time, keep pushing boundaries and mastering your TMF!
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Enjoy the show! #clinicalresearch #trialmasterfile #clinicaltrials

Non-Interventional Studies (NIS) Summary| NIS Regulations| GCP| Regulations|

Welcome to another insightful episode of the TMF Daily Podcast! Today, we're thrilled to host Stuart McCully, the co-founder of RWR-Regs, a distinguished figure with over two decades of experience in clinical research. Stuart's unique expertise lies in decoding and adeptly applying regulations, guidelines, and best practices, transforming them into actionable strategies for his clients.
In this episode, we delve into:
*The fundamentals and significance of non-interventional studies in clinical research. *Key differences between non-interventional and interventional studies.
*Navigating the regulatory landscape for non-interventional studies and common challenges. *Real-world applications and insights gained from non-interventional studies.
*Methodologies used in conducting non-interventional studies to ensure validity and reliability.
*Emerging trends and advancements in non-interventional studies. *Approaches to data collection and analysis, ensuring patient privacy and data integrity.
*The role of technology and data analytics in enhancing study efficiency and effectiveness.
*The importance of collaboration and partnerships in conducting successful non-interventional studies.
*Advice for researchers and organizations embarking on non-interventional studies for the first time.
Join us for this engaging conversation with Stuart McCully, as we explore the intricacies of non-interventional studies and gain invaluable insights from his extensive experience.
Don't forget to like, comment, and subscribe for more episodes that keep you at the forefront of the Trial Master File!
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Enjoy the show!
#noninterventional #clinicalresearch #trialmasterfile #clinicaltrials #study

Inside the Role of an Associate Director of TMF

In this episode, we shine the spotlight on the pivotal role of the Associate Director of TMF with the insightful Annette Bungo. Join us as we dive deep into:
The daily grind and responsibilities of an Associate Director of TMF.
The fascinating career path that leads to this powerhouse role.
Key skills and attributes that drive success in this position.
Key Topics:
Journey to the Role:
Pivotal moments and experiences that shaped Annette’s career path.
A Day in the Life:
Key responsibilities and daily activities of an Associate Director of TMF.
Essential Skills and Attributes:
What sets apart a successful Associate Director of TMF.
Challenges and Solutions:
Biggest obstacles faced in keeping TMF inspection-ready and strategies to overcome them.
Staying Ahead:
Recent initiatives and breakthroughs led by Annette.
Presentation at CDISC:
Preparation tips for delivering a clear, engaging, and impactful presentation.
Escalation Criteria:
Determining when to escalate a TMF issue to senior leadership.
Advice for Aspiring TMF Professionals:
Tips and focus areas for those aiming to reach the level of an Associate Director of TMF.
Best Career Advice:
The most valuable career advice received by Annette and from whom.
Favorite TMF Document:
Annette’s favorite TMF document and why it stands out to her.

Research Compliance in Shaping the Future of TMF

In this episode, we dive into the critical role of research compliance in the Trial Master File (TMF) and explore the invaluable insights Edye's extensive experience brings to the table. Whether you're new to the world of clinical research or a seasoned professional, you won't want to miss the wisdom Edye shares on maintaining TMF integrity and compliance.
Key Topics Covered:
-Edye's fascinating career journey and how she transitioned into clinical research. -Practical implications of compliance with the TMF.
-Essential TMF components crucial for regulatory compliance. -Common challenges in maintaining a compliant TMF and strategies to overcome them.
-Effective documentation and organization techniques for trial documents. -Conducting TMF audits to identify and rectify compliance issues.
-Ethical considerations in TMF management.
-The importance of training and education in promoting TMF compliance. -Staying updated on regulatory changes and industry best practices.
-Emerging trends and developments in TMF management. Listen Now: Tune in to hear Edye Edens' expert insights on research compliance and the Trial Master File.
This episode is packed with valuable information that can help you enhance your TMF processes and stay ahead in the ever-evolving world of clinical research.
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Alumni Spotlight: Susan Swonger

Susan Swonger, eTMF Specialist alumni, shares with us why she chose the eTMF Specialist course with the hands on experience with Medidata Rave eTMF and what she loved about the course.

Behind the Scenes: The Crucial Role of a TMF Manager

In this episode, Nina Apfelbaum, an outstanding Trial Master File (TMF) professional, shares her insights on the role of a TMF Manager. With a stellar record in documentation and regulatory compliance, Nina’s expertise ensures the seamless operation of TMFs and the success of being inspection-ready.
 
Episode Highlights:
Daily Responsibilities: Explore what a typical day looks like for a TMF Manager and the essential skills required for the role.
Challenges and Solutions: Hear about the biggest challenges Nina faces in managing the TMF and her strategies for overcoming them.
Regulatory Compliance: Learn how Nina ensures the TMF meets all regulatory requirements and guidelines.
Quality Control: Nina’s methods for ensuring all TMF documents are accurate and up-to-date.
Future Trends: Nina’s insights on emerging trends and changes in TMF management in the coming years.
You're watching TMF Daily Podcast, where we talk about all things related to the trial master file (TMF). We interview some of the brightest minds in the industry.
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Enjoy the show!
#trialmaster #clinicalresearch #clinicalresearch